Trial Outcomes & Findings for Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis (NCT NCT02531633)
NCT ID: NCT02531633
Last Updated: 2019-07-31
Results Overview
Sustained remission was defined as having achieved all of the following: 1) remission at Week 12, 2) absence of disease flare Week 12 through Week 52, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of erythrocyte sedimentation rate (ESR) \[\<30 millimeters per hour\] and C-reactive Protein (CRP) \[\<1 milligram/deciliter\]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission at Week 52 is presented. Only those participants who completed Week 52 visit or withdrew before 10 Oct 2017 were included in the analysis.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
161 participants
Primary outcome timeframe
Week 52
Results posted on
2019-07-31
Participant Flow
This was a multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of sirukumab in treatment of participants with Giant Cell Arteritis (GCA). A total of 161 participants were enrolled.
This study was conducted in 2 distinct parts (Part A and Part B), Part A was a 52-week double-blind treatment phase and Part B was a 104-week long-term extension phase with the option to receive open-label sirukumab (SIR) (up to a 52-week duration of open-label treatment). This study was terminated early by sponsor.
Participant milestones
| Measure |
Part A:SIR 100 mg SC q2w+6 Month Prednisone
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
Part A:SIR 100 mg SC q2w+3 Month Prednisone
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
Part A:SIR 50 mg SC q4w+6 Month Prednisone
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
Part A:Placebo SC q2w + 6 Month Prednisone
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
Part A:Placebo SC q2w+12 Month Prednisone
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
Part B:SIR 100 mg SC q2w+6 Month Prednisone
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A
|
Part B:SIR 100 mg SC q2w+3 Month Prednisone
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A
|
Part B:SIR 50 mg SC q4w+6 Month Prednisone
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A
|
Part B:Placebo SC q2w + 6 Month Prednisone
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A
|
Part B:Placebo SC q2w + 12 Month Prednisone
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A (52 Weeks)
STARTED
|
42
|
39
|
26
|
27
|
27
|
0
|
0
|
0
|
0
|
0
|
|
Part A (52 Weeks)
Completed Part A and Didn't Enter Part B
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A (52 Weeks)
COMPLETED
|
8
|
5
|
4
|
5
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Part A (52 Weeks)
NOT COMPLETED
|
34
|
34
|
22
|
22
|
23
|
0
|
0
|
0
|
0
|
0
|
|
Part B (104 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
0
|
8
|
5
|
4
|
5
|
4
|
|
Part B (104 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B (104 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
8
|
5
|
4
|
5
|
4
|
Reasons for withdrawal
| Measure |
Part A:SIR 100 mg SC q2w+6 Month Prednisone
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
Part A:SIR 100 mg SC q2w+3 Month Prednisone
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
Part A:SIR 50 mg SC q4w+6 Month Prednisone
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
Part A:Placebo SC q2w + 6 Month Prednisone
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
Part A:Placebo SC q2w+12 Month Prednisone
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
Part B:SIR 100 mg SC q2w+6 Month Prednisone
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A
|
Part B:SIR 100 mg SC q2w+3 Month Prednisone
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A
|
Part B:SIR 50 mg SC q4w+6 Month Prednisone
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A
|
Part B:Placebo SC q2w + 6 Month Prednisone
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A
|
Part B:Placebo SC q2w + 12 Month Prednisone
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A (52 Weeks)
Sponsor request
|
24
|
24
|
18
|
18
|
19
|
0
|
0
|
0
|
0
|
0
|
|
Part A (52 Weeks)
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A (52 Weeks)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part A (52 Weeks)
Physician Decision
|
1
|
4
|
3
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A (52 Weeks)
Withdrawal by Subject
|
6
|
6
|
1
|
3
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Part A (52 Weeks)
Other
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B (104 Weeks)
Sponsor request
|
0
|
0
|
0
|
0
|
0
|
8
|
5
|
3
|
5
|
4
|
|
Part B (104 Weeks)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis
Baseline characteristics by cohort
| Measure |
SIR100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
70.5 Years
STANDARD_DEVIATION 7.25 • n=5 Participants
|
68.1 Years
STANDARD_DEVIATION 6.72 • n=7 Participants
|
67.5 Years
STANDARD_DEVIATION 9.45 • n=5 Participants
|
71.6 Years
STANDARD_DEVIATION 7.10 • n=4 Participants
|
70.7 Years
STANDARD_DEVIATION 8.96 • n=21 Participants
|
69.6 Years
STANDARD_DEVIATION 7.85 • n=10 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
124 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
37 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White: Arabic/North African Heritage
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian/European Heritage
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
156 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: Intent-to-Treat (ITT) Population comprised of all randomized participants who received at least 1 dose of SC investigational product (IP).
Sustained remission was defined as having achieved all of the following: 1) remission at Week 12, 2) absence of disease flare Week 12 through Week 52, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of erythrocyte sedimentation rate (ESR) \[\<30 millimeters per hour\] and C-reactive Protein (CRP) \[\<1 milligram/deciliter\]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission at Week 52 is presented. Only those participants who completed Week 52 visit or withdrew before 10 Oct 2017 were included in the analysis.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=17 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=13 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=9 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=9 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=7 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Number of Participants in Sustained Remission at Week 52
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: ITT-Part B Population included all randomized participants who received at least 1 dose of SC IP in Part A and entered Part B.
Participants who remained in sustained remission without requirement for rescue therapy or treatment change at each scheduled visit of Part B were defined as participants having achieved all of the following criteria: 1. Participants in sustained remission at the Week 52 visit of Part A, 2. Absence of disease flare, 3. No requirement for rescue therapy at any time through Week 24 of Part B, 4. No requirement for treatment change at any time through Week 24 of Part B. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR \[\<30 millimeters per hour\] and CRP \[\<1 milligram/deciliter\]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=2 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24
|
NA Participants
5 participants in clinical remission entered Part B, all withdrew prior to week 24. Therefore, No data was available for week 24 for this population.
|
NA Participants
5 participants in clinical remission entered Part B, all withdrew prior to week 24. Therefore, No data was available for week 24 for this population.
|
NA Participants
5 participants in clinical remission entered Part B, all withdrew prior to week 24. Therefore, No data was available for week 24 for this population.
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Cumulative prednisone is the dose from the taper (both open-label and blinded) as well as from the corticosteroid rescue therapies. Cumulative dose at the specified Week was derived as the sum of all the doses from Baseline to the specified Week at each visit was calculated based on the number of participants who attended that visit. For the main analysis of cumulative prednisone dose over time. Data for Prednisone Dose- Study Drug and Prednisone Equivalent Concomitant Therapy for part A is presented. ITT population and the number of participants included at specific time points were based on the participants who attended a scheduled or unscheduled visit mapped to that time point and received a total prednisone dose greater than 0 mg.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Cumulative Prednisone Dose Over Time
Week 2, n= 40,39,26,27,26
|
439.575 Milligrams
Standard Deviation 237.8990
|
464.923 Milligrams
Standard Deviation 299.6445
|
424.577 Milligrams
Standard Deviation 270.2183
|
432.815 Milligrams
Standard Deviation 315.6851
|
430.846 Milligrams
Standard Deviation 241.3540
|
|
Part A: Cumulative Prednisone Dose Over Time
Week 12,n=34,32,24,22,24
|
1344.441 Milligrams
Standard Deviation 779.6775
|
1063.773 Milligrams
Standard Deviation 619.4002
|
1208.167 Milligrams
Standard Deviation 650.6975
|
1379.409 Milligrams
Standard Deviation 1255.4397
|
1462.917 Milligrams
Standard Deviation 630.1717
|
|
Part A: Cumulative Prednisone Dose Over Time
Week 16,n=32,30,24,22,22
|
1545.602 Milligrams
Standard Deviation 964.3264
|
1182.288 Milligrams
Standard Deviation 718.6186
|
1348.750 Milligrams
Standard Deviation 689.2484
|
1672.795 Milligrams
Standard Deviation 1261.7121
|
1729.977 Milligrams
Standard Deviation 701.3734
|
|
Part A: Cumulative Prednisone Dose Over Time
Week 24,n=30,25,19,18,17
|
1878.458 Milligrams
Standard Deviation 1333.1175
|
1495.015 Milligrams
Standard Deviation 1055.9615
|
1626.342 Milligrams
Standard Deviation 813.8284
|
1917.444 Milligrams
Standard Deviation 861.6887
|
2299.471 Milligrams
Standard Deviation 840.8758
|
|
Part A: Cumulative Prednisone Dose Over Time
Week 28,n=24,23,15,17,15
|
2000.813 Milligrams
Standard Deviation 1594.5982
|
1575.549 Milligrams
Standard Deviation 1170.7294
|
1797.533 Milligrams
Standard Deviation 933.3753
|
2141.294 Milligrams
Standard Deviation 1082.2754
|
2387.800 Milligrams
Standard Deviation 741.1663
|
|
Part A: Cumulative Prednisone Dose Over Time
Week 32,n=19,21,13,15,18
|
2216.000 Milligrams
Standard Deviation 1953.8211
|
1716.863 Milligrams
Standard Deviation 1328.1426
|
1859.346 Milligrams
Standard Deviation 858.5431
|
2531.417 Milligrams
Standard Deviation 1327.9125
|
2404.500 Milligrams
Standard Deviation 808.8642
|
|
Part A: Cumulative Prednisone Dose Over Time
Week 36,n=19,17,14,13,14
|
2321.711 Milligrams
Standard Deviation 2090.2393
|
1803.919 Milligrams
Standard Deviation 1536.5304
|
1705.214 Milligrams
Standard Deviation 802.8858
|
2617.817 Milligrams
Standard Deviation 1636.2516
|
2717.696 Milligrams
Standard Deviation 897.0689
|
|
Part A: Cumulative Prednisone Dose Over Time
Week 40,n=18,15,11,13,12
|
2003.264 Milligrams
Standard Deviation 1426.0271
|
2023.342 Milligrams
Standard Deviation 1651.4092
|
1842.500 Milligrams
Standard Deviation 904.4136
|
2960.144 Milligrams
Standard Deviation 1736.2249
|
2963.865 Milligrams
Standard Deviation 909.0195
|
|
Part A: Cumulative Prednisone Dose Over Time
Week 44,n=17,13,10,12,13
|
2051.603 Milligrams
Standard Deviation 1588.9627
|
1481.115 Milligrams
Standard Deviation 1381.3957
|
1980.733 Milligrams
Standard Deviation 1444.8664
|
2783.542 Milligrams
Standard Deviation 1776.0608
|
2954.760 Milligrams
Standard Deviation 1022.5491
|
|
Part A: Cumulative Prednisone Dose Over Time
Week 48,n=10,16,9,8,11
|
1821.325 Milligrams
Standard Deviation 1139.5986
|
1601.656 Milligrams
Standard Deviation 1362.9717
|
1562.333 Milligrams
Standard Deviation 828.5650
|
2859.208 Milligrams
Standard Deviation 1882.7422
|
3167.898 Milligrams
Standard Deviation 1195.4020
|
|
Part A: Cumulative Prednisone Dose Over Time
Week 52,n=11,10,6,7,6
|
2974.295 Milligrams
Standard Deviation 2966.6259
|
2418.213 Milligrams
Standard Deviation 2085.2345
|
2556.222 Milligrams
Standard Deviation 1363.1832
|
3157.054 Milligrams
Standard Deviation 1988.0610
|
3603.229 Milligrams
Standard Deviation 1477.6777
|
|
Part A: Cumulative Prednisone Dose Over Time
Week 4,n=40,39,26,25,27
|
701.100 Milligrams
Standard Deviation 370.9798
|
741.115 Milligrams
Standard Deviation 436.4205
|
701.192 Milligrams
Standard Deviation 439.7251
|
705.480 Milligrams
Standard Deviation 601.9706
|
751.407 Milligrams
Standard Deviation 431.3442
|
|
Part A: Cumulative Prednisone Dose Over Time
Week 8,n=37, 37,26,23,26
|
1086.676 Milligrams
Standard Deviation 600.7400
|
987.730 Milligrams
Standard Deviation 559.4458
|
1014.731 Milligrams
Standard Deviation 592.3515
|
1161.391 Milligrams
Standard Deviation 1202.8504
|
1129.077 Milligrams
Standard Deviation 546.8037
|
|
Part A: Cumulative Prednisone Dose Over Time
Week 20,n=29,27,21,24,19
|
1690.302 Milligrams
Standard Deviation 1173.6005
|
1339.546 Milligrams
Standard Deviation 888.5007
|
1475.786 Milligrams
Standard Deviation 734.7667
|
1646.177 Milligrams
Standard Deviation 701.5240
|
2041.632 Milligrams
Standard Deviation 771.3504
|
SECONDARY outcome
Timeframe: Weeks 4, 8 and 12Population: ITT-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Sustained remission was defined as having achieved all of the following: 1) remission at Week 12 (absence of signs and symptoms of GCA and normalization of ESR and CRP), 2) absence of disease flare Week 12 through Week 52 with or without elevations in ESR and/or CRP, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR \[\<30millimeters per hour\] and CRP \[\<1milligram/deciliter\]) and Flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission over time for Part B is presented. Only participants who were in sustained remission at Week 52 of Part A, who Completed the Week X Visit of Part B or who Withdraw before 10th of October 2017 were included in the analysis.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=2 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Number of Participants in Sustained Remission Over Time
Week 4,n=1,1,1,0,0
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Part B: Number of Participants in Sustained Remission Over Time
Week 8,n=1,0,1,0,0
|
1 Participants
|
—
|
1 Participants
|
—
|
—
|
|
Part B: Number of Participants in Sustained Remission Over Time
Week 12,n=1,0,0,0,0
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: ITT Population. Only participants who achieved clinical remission were included in this analysis.
Clinical remission was defined as absence of clinical signs and symptoms of GCA, which was determined by a lack of flare for the participant. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to first disease flare (days) was calculated as (Date of First Flare - Date of Clinical Remission + 1 day). Data for Time to first disease flare after clinical remission for part A is presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=40 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Time to First Disease Flare After Clinical Remission
|
NA Days
No. of participants achieving remission was not sufficient to calculate the median survival time from the Kaplan-Meier analysis, as less than half of subjects who achieved clinical remission in any dose arm had a flare at or before Week 52
|
NA Days
No. of participants achieving remission was not sufficient to calculate the median survival time from the Kaplan-Meier analysis, as less than half of subjects who achieved clinical remission in any dose arm had a flare at or before Week 52
|
NA Days
Interval 176.0 to
No. of participants achieving remission was not sufficient to calculate the median survival time from the Kaplan-Meier analysis, as less than half of subjects who achieved clinical remission in any dose arm had a flare at or before Week 52
|
NA Days
Interval 99.0 to
No. of participants achieving remission was not sufficient to calculate the median survival time from the Kaplan-Meier analysis, as less than half of subjects who achieved clinical remission in any dose arm had a flare at or before Week 52
|
NA Days
Interval 183.0 to
No. of participants achieving remission was not sufficient to calculate the median survival time from the Kaplan-Meier analysis, as less than half of subjects who achieved clinical remission in any dose arm had a flare at or before Week 52
|
SECONDARY outcome
Timeframe: Week 52Population: ITT-Part B Population. Only those participants with available data at the specified time points were analyzed.
Clinical remission was defined as absence of clinical signs and symptoms of GCA. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to event (days) is defined as the duration in days from the date of the Week 52 visit of Part A to the start date of Event (Date of First Flare - Date of Week 52 visit of Part A + 1). Data for Time to first disease flare after clinical remission for part B is presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=2 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Time to First Disease Flare for Participants in Sustained Remission
|
NA Days
No. of participants achieving remission was not sufficient to calculate the median survival time from the Kaplan-Meier analysis, as less than half of subjects who achieved clinical remission in any dose arm had a flare at or before Week 52
|
NA Days
No. of participants achieving remission was not sufficient to calculate the median survival time from the Kaplan-Meier analysis, as less than half of subjects who achieved clinical remission in any dose arm had a flare at or before Week 52
|
NA Days
No. of participants achieving remission was not sufficient to calculate the median survival time from the Kaplan-Meier analysis, as less than half of subjects who achieved clinical remission in any dose arm had a flare at or before Week 52
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants; participants who did not reach Week 2 were not included in this analysis. Data for number of disease flares per participant over time for part A were presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Number of Disease Flares Over Time
Week 2, n=38, 39,26,25,27
|
1 Disease flares
|
2 Disease flares
|
2 Disease flares
|
0 Disease flares
|
2 Disease flares
|
|
Part A: Number of Disease Flares Over Time
Week 4, n=37,37,25,23,27
|
3 Disease flares
|
4 Disease flares
|
3 Disease flares
|
0 Disease flares
|
2 Disease flares
|
|
Part A: Number of Disease Flares Over Time
Week 8, n=34,32,24,23,23
|
2 Disease flares
|
6 Disease flares
|
3 Disease flares
|
1 Disease flares
|
5 Disease flares
|
|
Part A: Number of Disease Flares Over Time
Week 12, n=32,29,24,22,22
|
4 Disease flares
|
9 Disease flares
|
4 Disease flares
|
4 Disease flares
|
4 Disease flares
|
|
Part A: Number of Disease Flares Over Time
Week 16, n=28,26,22,19,19
|
4 Disease flares
|
9 Disease flares
|
5 Disease flares
|
9 Disease flares
|
4 Disease flares
|
|
Part A: Number of Disease Flares Over Time
Week 20, n=26,23,19,18,16
|
4 Disease flares
|
9 Disease flares
|
6 Disease flares
|
10 Disease flares
|
3 Disease flares
|
|
Part A: Number of Disease Flares Over Time
Week 28, n=19,18,12,14,14
|
5 Disease flares
|
8 Disease flares
|
8 Disease flares
|
11 Disease flares
|
5 Disease flares
|
|
Part A: Number of Disease Flares Over Time
Week 32, n=19,15,10,12,13
|
5 Disease flares
|
8 Disease flares
|
5 Disease flares
|
10 Disease flares
|
6 Disease flares
|
|
Part A: Number of Disease Flares Over Time
Week 36, n=15,13,10,12,13
|
3 Disease flares
|
8 Disease flares
|
5 Disease flares
|
10 Disease flares
|
6 Disease flares
|
|
Part A: Number of Disease Flares Over Time
Week 44, n=11,11,6,8,9
|
1 Disease flares
|
8 Disease flares
|
3 Disease flares
|
6 Disease flares
|
7 Disease flares
|
|
Part A: Number of Disease Flares Over Time
Week 40, n=15,11,9,10,10
|
2 Disease flares
|
7 Disease flares
|
5 Disease flares
|
8 Disease flares
|
5 Disease flares
|
|
Part A: Number of Disease Flares Over Time
Week 48, n=9,8,5,8,5
|
1 Disease flares
|
4 Disease flares
|
1 Disease flares
|
7 Disease flares
|
3 Disease flares
|
|
Part A: Number of Disease Flares Over Time
Week 52, n=9,5,5,5,4
|
1 Disease flares
|
2 Disease flares
|
1 Disease flares
|
7 Disease flares
|
4 Disease flares
|
|
Part A: Number of Disease Flares Over Time
Week 24, n=23,21,16,17,16
|
6 Disease flares
|
9 Disease flares
|
8 Disease flares
|
11 Disease flares
|
5 Disease flares
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Number of participants with at least one hospitalization for disease flare at a given visit is the number of participants with at least one hospitalization for disease flare between first SC IP intake and the day of the given visit. Data for participants requiring at least one hospitalization for disease flare for part A is presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Number of Participants With at Least One Hospitalization for Disease Flare
Week 2, n=38, 39,26,25,27
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With at Least One Hospitalization for Disease Flare
Week 4, n=37,37,25,23,27
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With at Least One Hospitalization for Disease Flare
Week 8, n=34,32,24,23,23
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With at Least One Hospitalization for Disease Flare
Week 16, n=28,26,22,19,19
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With at Least One Hospitalization for Disease Flare
Week 24, n=23,21,16,17,16
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With at Least One Hospitalization for Disease Flare
Week 28, n=19,18,12,14,14
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With at Least One Hospitalization for Disease Flare
Week 40, n=15,11,9,10,10
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With at Least One Hospitalization for Disease Flare
Week 44, n=11,11,6,8,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With at Least One Hospitalization for Disease Flare
Week 48, n=9,8,5,8,5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With at Least One Hospitalization for Disease Flare
Week 52, n=9,5,5,5,4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With at Least One Hospitalization for Disease Flare
Week 12, n=32,29,24,22,22
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With at Least One Hospitalization for Disease Flare
Week 20, n=26,23,19,18,16
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With at Least One Hospitalization for Disease Flare
Week 32, n=19,15,10,12,13
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With at Least One Hospitalization for Disease Flare
Week 36, n=15,13,10,12,13
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Number of hospitalizations for disease flare at given visit is the number of hospitalizations for disease flare between first SC IP intake and the day of the of the given visit.. Data for number of hospitalizations for disease flare over time for part A was presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Number of Hospitalizations for Disease Flare Over Time
Week 2, n=38, 39,26,25,27
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
|
Part A: Number of Hospitalizations for Disease Flare Over Time
Week 4, n=37,37,25,23,27
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
|
Part A: Number of Hospitalizations for Disease Flare Over Time
Week 48, n=9,8,5,8,5
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
|
Part A: Number of Hospitalizations for Disease Flare Over Time
Week 8, n=34,32,24,23,23
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
|
Part A: Number of Hospitalizations for Disease Flare Over Time
Week 12, n=32,29,24,22,22
|
2 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
|
Part A: Number of Hospitalizations for Disease Flare Over Time
Week 16, n=28,26,22,19,19
|
2 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
|
Part A: Number of Hospitalizations for Disease Flare Over Time
Week 20, n=26,23,19,18,16
|
2 Number of Hospitalizations
|
0 Number of Hospitalizations
|
1 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
|
Part A: Number of Hospitalizations for Disease Flare Over Time
Week 24, n=23,21,16,17,16
|
2 Number of Hospitalizations
|
0 Number of Hospitalizations
|
1 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
|
Part A: Number of Hospitalizations for Disease Flare Over Time
Week 28, n=19,18,12,14,14
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
1 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
|
Part A: Number of Hospitalizations for Disease Flare Over Time
Week 32, n=19,15,10,12,13
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
|
Part A: Number of Hospitalizations for Disease Flare Over Time
Week 36, n=15,13,10,12,13
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
|
Part A: Number of Hospitalizations for Disease Flare Over Time
Week 40, n=15,11,9,10,10
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
|
Part A: Number of Hospitalizations for Disease Flare Over Time
Week 44, n=11,11,6,8,9
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
|
Part A: Number of Hospitalizations for Disease Flare Over Time
Week 52, n=9,5,5,5,4
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
0 Number of Hospitalizations
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 12, 24, 36, 52Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
SF-36v2 acute health survey questionnaire consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for Physical Component Summary (PCS), Mental Component Summary (MCS) scores was presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time
MCS,Week 52, n=9,5,5,5,4
|
44.810 Scores on scale
Standard Deviation 6.4757
|
45.008 Scores on scale
Standard Deviation 2.2373
|
42.004 Scores on scale
Standard Deviation 5.5695
|
42.258 Scores on scale
Standard Deviation 4.1002
|
42.125 Scores on scale
Standard Deviation 1.9020
|
|
Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time
PCS,Week 24, n=23,20,15,17,16
|
50.023 Scores on scale
Standard Deviation 11.4731
|
45.677 Scores on scale
Standard Deviation 12.1192
|
45.097 Scores on scale
Standard Deviation 15.0552
|
46.911 Scores on scale
Standard Deviation 9.2901
|
44.280 Scores on scale
Standard Deviation 11.4740
|
|
Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time
PCS,Week 36, n=15,13,10,12,13
|
51.989 Scores on scale
Standard Deviation 10.7521
|
47.069 Scores on scale
Standard Deviation 12.7103
|
46.005 Scores on scale
Standard Deviation 12.2496
|
48.336 Scores on scale
Standard Deviation 10.0154
|
44.946 Scores on scale
Standard Deviation 10.1921
|
|
Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time
PCS,Baseline, n=42,38,25,23,27
|
49.258 Scores on scale
Standard Deviation 11.7655
|
43.271 Scores on scale
Standard Deviation 12.3169
|
42.919 Scores on scale
Standard Deviation 11.7298
|
49.240 Scores on scale
Standard Deviation 9.2759
|
45.470 Scores on scale
Standard Deviation 12.8498
|
|
Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time
PCS,Week 12, n=31,28,24,22,22
|
51.519 Scores on scale
Standard Deviation 10.5352
|
43.128 Scores on scale
Standard Deviation 11.4559
|
43.655 Scores on scale
Standard Deviation 11.0324
|
48.552 Scores on scale
Standard Deviation 10.4184
|
47.007 Scores on scale
Standard Deviation 12.8749
|
|
Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time
PCS,Week 52, n=9,5,5,5,4
|
50.269 Scores on scale
Standard Deviation 10.8743
|
53.690 Scores on scale
Standard Deviation 7.9049
|
53.608 Scores on scale
Standard Deviation 7.7721
|
52.026 Scores on scale
Standard Deviation 6.4892
|
53.143 Scores on scale
Standard Deviation 12.8351
|
|
Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time
MCS,Week 12, n=31,28,24,22,22
|
43.955 Scores on scale
Standard Deviation 4.6164
|
45.264 Scores on scale
Standard Deviation 5.7982
|
46.393 Scores on scale
Standard Deviation 6.1792
|
43.746 Scores on scale
Standard Deviation 5.3179
|
43.182 Scores on scale
Standard Deviation 4.6707
|
|
Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time
MCS,Week 24, n=23,20,15,17,16
|
44.538 Scores on scale
Standard Deviation 5.6952
|
45.954 Scores on scale
Standard Deviation 5.4884
|
44.877 Scores on scale
Standard Deviation 6.5210
|
45.372 Scores on scale
Standard Deviation 6.4561
|
45.526 Scores on scale
Standard Deviation 5.8924
|
|
Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time
MCS,Week 36, n=15,13,10,12,13
|
45.258 Scores on scale
Standard Deviation 5.2429
|
45.540 Scores on scale
Standard Deviation 4.8330
|
44.550 Scores on scale
Standard Deviation 6.7199
|
42.959 Scores on scale
Standard Deviation 4.8484
|
46.755 Scores on scale
Standard Deviation 4.8284
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 12, 24, 36, 52Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score).
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time
Week 12, n=31,28,24,22,22
|
0.7866 Scores on scale
Standard Deviation 0.22042
|
0.7024 Scores on scale
Standard Deviation 0.22087
|
0.7452 Scores on scale
Standard Deviation 0.17942
|
0.7228 Scores on scale
Standard Deviation 0.16993
|
0.7069 Scores on scale
Standard Deviation 0.22289
|
|
Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time
Baseline, n=42,38,25,23,27
|
0.7918 Scores on scale
Standard Deviation 0.20589
|
0.6681 Scores on scale
Standard Deviation 0.31299
|
0.6912 Scores on scale
Standard Deviation 0.19348
|
0.7429 Scores on scale
Standard Deviation 0.22387
|
0.7554 Scores on scale
Standard Deviation 0.16610
|
|
Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time
Week 24, n=23,20,15,17,16
|
0.7485 Scores on scale
Standard Deviation 0.20310
|
0.7217 Scores on scale
Standard Deviation 0.21397
|
0.7135 Scores on scale
Standard Deviation 0.24006
|
0.7323 Scores on scale
Standard Deviation 0.10346
|
0.7301 Scores on scale
Standard Deviation 0.11498
|
|
Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time
Week 36, n=15,13,10,12,13
|
0.8011 Scores on scale
Standard Deviation 0.13468
|
0.7454 Scores on scale
Standard Deviation 0.22373
|
0.7774 Scores on scale
Standard Deviation 0.11809
|
0.6950 Scores on scale
Standard Deviation 0.15242
|
0.7506 Scores on scale
Standard Deviation 0.17536
|
|
Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time
Week 52, n=9,5,5,5,4
|
0.8210 Scores on scale
Standard Deviation 0.13502
|
0.7628 Scores on scale
Standard Deviation 0.15352
|
0.8092 Scores on scale
Standard Deviation 0.04275
|
0.7864 Scores on scale
Standard Deviation 0.05892
|
0.8068 Scores on scale
Standard Deviation 0.06050
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 12, 24, 36, 52Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of the 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. The index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for the conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1 (best score). The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 'Best imaginable health state' and 'Worst imaginable health state'.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time
Baseline, n=42,38,25,23,27
|
67.0 Scores on scale
Standard Deviation 17.83
|
65.6 Scores on scale
Standard Deviation 21.43
|
57.0 Scores on scale
Standard Deviation 17.61
|
62.1 Scores on scale
Standard Deviation 23.81
|
65.1 Scores on scale
Standard Deviation 16.00
|
|
Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time
Week 12, n=31,28,24,22,22
|
74.3 Scores on scale
Standard Deviation 19.77
|
64.2 Scores on scale
Standard Deviation 22.89
|
68.4 Scores on scale
Standard Deviation 19.39
|
63.3 Scores on scale
Standard Deviation 22.61
|
65.5 Scores on scale
Standard Deviation 21.33
|
|
Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time
Week 24, n=23,20,15,17,16
|
74.6 Scores on scale
Standard Deviation 16.26
|
70.6 Scores on scale
Standard Deviation 24.05
|
65.1 Scores on scale
Standard Deviation 23.11
|
64.9 Scores on scale
Standard Deviation 19.03
|
61.5 Scores on scale
Standard Deviation 19.71
|
|
Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time
Week 36, n=15,13,10,12,13
|
79.5 Scores on scale
Standard Deviation 9.55
|
73.9 Scores on scale
Standard Deviation 24.55
|
66.9 Scores on scale
Standard Deviation 20.72
|
68.3 Scores on scale
Standard Deviation 18.66
|
61.6 Scores on scale
Standard Deviation 21.29
|
|
Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time
Week 52, n=9,5,5,5,4
|
79.9 Scores on scale
Standard Deviation 9.74
|
80.6 Scores on scale
Standard Deviation 16.50
|
78.4 Scores on scale
Standard Deviation 14.77
|
60.2 Scores on scale
Standard Deviation 26.33
|
70.0 Scores on scale
Standard Deviation 27.41
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 12, 24, 36, 52Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Each negatively-worded item response was recoded so that 0 is a bad response and 4 is good response. All responses were added with equal weight to obtain the total score. The total score was calculated as the sum of all the individual items after recoding some of the items.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time
Baseline, n=42,38,25,23,27
|
38.7 Scores on scale
Standard Deviation 10.72
|
34.2 Scores on scale
Standard Deviation 12.25
|
31.1 Scores on scale
Standard Deviation 9.89
|
38.0 Scores on scale
Standard Deviation 8.37
|
34.1 Scores on scale
Standard Deviation 13.32
|
|
Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time
Week 12, n=31,28,24,22,22
|
40.2 Scores on scale
Standard Deviation 8.83
|
32.7 Scores on scale
Standard Deviation 11.25
|
34.3 Scores on scale
Standard Deviation 11.12
|
38.5 Scores on scale
Standard Deviation 9.82
|
35.5 Scores on scale
Standard Deviation 13.34
|
|
Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time
Week 24, n=23,20,15,17,16
|
38.1 Scores on scale
Standard Deviation 10.48
|
36.5 Scores on scale
Standard Deviation 13.22
|
31.2 Scores on scale
Standard Deviation 13.09
|
36.2 Scores on scale
Standard Deviation 6.15
|
36.0 Scores on scale
Standard Deviation 9.18
|
|
Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time
Week 36, n=15,13,10,12,13
|
41.4 Scores on scale
Standard Deviation 9.41
|
38.4 Scores on scale
Standard Deviation 9.95
|
36.9 Scores on scale
Standard Deviation 10.88
|
40.9 Scores on scale
Standard Deviation 6.49
|
37.5 Scores on scale
Standard Deviation 10.02
|
|
Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time
Week 52, n=9,5,5,5,4
|
42.1 Scores on scale
Standard Deviation 6.72
|
43.0 Scores on scale
Standard Deviation 6.48
|
40.4 Scores on scale
Standard Deviation 5.22
|
44.0 Scores on scale
Standard Deviation 5.48
|
41.0 Scores on scale
Standard Deviation 12.25
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain on a 11-point numeric rating scale ranging from 0, "no pain" to 10, "the worst pain imaginable". Data for NRS scores over time for part A is reported.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time
Week 16, n=27,25,22,19,19
|
1.4 Scores on scale
Standard Deviation 2.22
|
3.3 Scores on scale
Standard Deviation 2.84
|
3.0 Scores on scale
Standard Deviation 2.60
|
2.4 Scores on scale
Standard Deviation 2.06
|
2.7 Scores on scale
Standard Deviation 2.16
|
|
Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time
Week 24, n=23,20,15,17,16
|
2.4 Scores on scale
Standard Deviation 2.82
|
2.5 Scores on scale
Standard Deviation 2.42
|
3.3 Scores on scale
Standard Deviation 2.94
|
2.4 Scores on scale
Standard Deviation 1.84
|
3.5 Scores on scale
Standard Deviation 2.22
|
|
Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time
Week 32, n=19,14,9,12,12
|
2.1 Scores on scale
Standard Deviation 2.57
|
1.9 Scores on scale
Standard Deviation 2.67
|
2.9 Scores on scale
Standard Deviation 1.90
|
2.6 Scores on scale
Standard Deviation 2.15
|
3.1 Scores on scale
Standard Deviation 2.35
|
|
Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time
Week 52, n=9,5,5,5,4
|
1.3 Scores on scale
Standard Deviation 1.66
|
0.8 Scores on scale
Standard Deviation 0.84
|
2.8 Scores on scale
Standard Deviation 2.28
|
2.2 Scores on scale
Standard Deviation 0.84
|
1.0 Scores on scale
Standard Deviation 0.82
|
|
Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time
Baseline, n=42,38,25,23,27
|
1.8 Scores on scale
Standard Deviation 2.31
|
2.5 Scores on scale
Standard Deviation 2.97
|
3.1 Scores on scale
Standard Deviation 2.27
|
2.6 Scores on scale
Standard Deviation 2.09
|
2.6 Scores on scale
Standard Deviation 2.39
|
|
Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time
Week 2, n=38,38,25,21,27
|
1.3 Scores on scale
Standard Deviation 1.55
|
2.8 Scores on scale
Standard Deviation 3.08
|
2.8 Scores on scale
Standard Deviation 1.96
|
2.6 Scores on scale
Standard Deviation 2.13
|
2.6 Scores on scale
Standard Deviation 2.63
|
|
Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time
Week 4, n=36,37,24,22,27
|
1.7 Scores on scale
Standard Deviation 2.16
|
3.1 Scores on scale
Standard Deviation 3.13
|
3.3 Scores on scale
Standard Deviation 2.20
|
2.4 Scores on scale
Standard Deviation 2.28
|
1.8 Scores on scale
Standard Deviation 1.72
|
|
Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time
Week 8, n=34,30,24,21,23
|
1.8 Scores on scale
Standard Deviation 2.42
|
2.9 Scores on scale
Standard Deviation 2.73
|
3.0 Scores on scale
Standard Deviation 2.54
|
2.1 Scores on scale
Standard Deviation 1.96
|
3.3 Scores on scale
Standard Deviation 2.82
|
|
Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time
Week 12, n=31,28,24,22,22
|
1.7 Scores on scale
Standard Deviation 2.30
|
3.6 Scores on scale
Standard Deviation 3.05
|
3.3 Scores on scale
Standard Deviation 2.42
|
2.3 Scores on scale
Standard Deviation 2.50
|
2.0 Scores on scale
Standard Deviation 2.08
|
|
Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time
Week 20, n=26,23,19,18,15
|
1.7 Scores on scale
Standard Deviation 2.27
|
2.9 Scores on scale
Standard Deviation 2.70
|
3.6 Scores on scale
Standard Deviation 2.63
|
1.4 Scores on scale
Standard Deviation 1.54
|
2.7 Scores on scale
Standard Deviation 2.02
|
|
Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time
Week 28, n=18,17,11,13,14
|
2.6 Scores on scale
Standard Deviation 2.38
|
2.8 Scores on scale
Standard Deviation 3.03
|
3.6 Scores on scale
Standard Deviation 2.87
|
2.3 Scores on scale
Standard Deviation 2.14
|
2.9 Scores on scale
Standard Deviation 2.40
|
|
Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time
Week 36, n=15,13,10,12,13
|
1.6 Scores on scale
Standard Deviation 1.88
|
2.0 Scores on scale
Standard Deviation 2.55
|
2.9 Scores on scale
Standard Deviation 2.02
|
2.3 Scores on scale
Standard Deviation 2.42
|
1.9 Scores on scale
Standard Deviation 1.93
|
|
Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time
Week 40, n=15,11,9,10,10
|
2.0 Scores on scale
Standard Deviation 2.54
|
2.0 Scores on scale
Standard Deviation 2.57
|
3.1 Scores on scale
Standard Deviation 2.09
|
1.9 Scores on scale
Standard Deviation 1.91
|
2.6 Scores on scale
Standard Deviation 2.07
|
|
Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time
Week 44, n=11,11,6,8,8
|
2.1 Scores on scale
Standard Deviation 2.74
|
1.9 Scores on scale
Standard Deviation 2.47
|
2.2 Scores on scale
Standard Deviation 1.72
|
1.3 Scores on scale
Standard Deviation 0.71
|
3.0 Scores on scale
Standard Deviation 2.39
|
|
Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time
Week 48, n=9,8,5,7,5
|
1.9 Scores on scale
Standard Deviation 2.42
|
0.8 Scores on scale
Standard Deviation 1.04
|
2.6 Scores on scale
Standard Deviation 0.89
|
1.6 Scores on scale
Standard Deviation 1.27
|
4.0 Scores on scale
Standard Deviation 3.74
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 12, 24, 36 and 52Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing "no difficulty" (0), "some difficulty" (1), "much difficulty" (2), and "unable to do" (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time
Week 24, n=10, 7,7,7,9
|
0.5875 Scores on scale
Standard Deviation 0.58940
|
0.8750 Scores on scale
Standard Deviation 0.78395
|
0.9821 Scores on scale
Standard Deviation 0.92823
|
0.9107 Scores on scale
Standard Deviation 0.83452
|
0.9583 Scores on scale
Standard Deviation 0.70986
|
|
Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time
Baseline, n=19,14,13,9,12
|
0.6776 Scores on scale
Standard Deviation 0.65658
|
1.1250 Scores on scale
Standard Deviation 0.75479
|
0.9615 Scores on scale
Standard Deviation 0.84376
|
0.8889 Scores on scale
Standard Deviation 0.80875
|
0.8646 Scores on scale
Standard Deviation 0.62034
|
|
Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time
Week 12, n=12,8,12,9,9
|
0.3229 Scores on scale
Standard Deviation 0.41785
|
1.0938 Scores on scale
Standard Deviation 0.91063
|
0.7292 Scores on scale
Standard Deviation 0.87392
|
0.5694 Scores on scale
Standard Deviation 0.54526
|
0.9306 Scores on scale
Standard Deviation 0.66764
|
|
Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time
Week 36, n=6,5,4,4,7
|
0.5208 Scores on scale
Standard Deviation 0.70007
|
0.8250 Scores on scale
Standard Deviation 0.80816
|
0.6250 Scores on scale
Standard Deviation 0.51031
|
0.5625 Scores on scale
Standard Deviation 0.58184
|
1.0000 Scores on scale
Standard Deviation 0.91287
|
|
Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time
Week 52, n=5,2,3,1,2
|
0.3000 Scores on scale
Standard Deviation 0.41079
|
0.3125 Scores on scale
Standard Deviation 0.44194
|
0.1667 Scores on scale
Standard Deviation 0.14434
|
0.0000 Scores on scale
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
0.1875 Scores on scale
Standard Deviation 0.26517
|
SECONDARY outcome
Timeframe: Weeks 12, 24 and 52Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Week 12,No Change, n=31,28,24,22,22
|
3 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
|
Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Week 12,Slightly Worse, n=31,28,24,22,22
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Week 12,Worse, n=31,28,24,22,22
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Week 12,Much Worse, n=31,28,24,22,22
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Week 24,Much Better, n=23,20,15,17,16
|
11 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
|
Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Week 24,Better, n=23,20,15,17,16
|
7 Participants
|
8 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
|
Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Week 24,No Change, n=23,20,15,17,16
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Week 24,Slightly Worse, n=23,20,15,17,16
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Week 24, Worse,n=23,20,15,17,16
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Week 24, Much Worse,n=23,20,15,17,16
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Week 52,Better, n=9,5,5,5,4
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Week 52,Slightly Better, n=9,5,5,5,4
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Week 52,Worse, n=9,5,5,5,4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Week 52,Much Worse, n=9,5,5,5,4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Week 52,No Change, n=9,5,5,5,4
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Week 52,Slightly Worse, n=9,5,5,5,4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Week 12,Much Better, n=31,28,24,22,22
|
11 Participants
|
7 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
|
Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Week 12,Better, n=31,28,24,22,22
|
11 Participants
|
10 Participants
|
11 Participants
|
4 Participants
|
11 Participants
|
|
Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Week 12, Slightly Better, n=31,28,24,22,22
|
3 Participants
|
5 Participants
|
4 Participants
|
8 Participants
|
3 Participants
|
|
Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Week 24, Slightly Better,n=23,20,15,17,16
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time
Week 52,Much Better, n=9,5,5,5,4
|
6 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS) of 10 centimeter (cm) ranging from 0 ("very well) to 10 ("very poor").
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time
Baseline, n=42,39,25,26,27
|
2.96 Scores on scale
Standard Deviation 2.148
|
3.72 Scores on scale
Standard Deviation 2.649
|
4.24 Scores on scale
Standard Deviation 2.049
|
3.60 Scores on scale
Standard Deviation 2.133
|
3.64 Scores on scale
Standard Deviation 2.732
|
|
Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time
Week 2, n=38,38,25,21,27
|
2.59 Scores on scale
Standard Deviation 1.923
|
3.51 Scores on scale
Standard Deviation 2.389
|
3.73 Scores on scale
Standard Deviation 1.911
|
3.45 Scores on scale
Standard Deviation 2.247
|
3.52 Scores on scale
Standard Deviation 2.177
|
|
Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time
Week 16, n=27,25,22,19,19
|
1.95 Scores on scale
Standard Deviation 2.237
|
3.82 Scores on scale
Standard Deviation 2.615
|
3.39 Scores on scale
Standard Deviation 2.523
|
2.86 Scores on scale
Standard Deviation 1.809
|
2.76 Scores on scale
Standard Deviation 1.777
|
|
Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time
Week 20, n=26,23,19,18,15
|
2.60 Scores on scale
Standard Deviation 2.089
|
3.20 Scores on scale
Standard Deviation 2.663
|
4.17 Scores on scale
Standard Deviation 2.334
|
2.45 Scores on scale
Standard Deviation 1.697
|
2.90 Scores on scale
Standard Deviation 1.869
|
|
Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time
Week 28, n=18,17,11,13,14
|
2.44 Scores on scale
Standard Deviation 2.094
|
3.09 Scores on scale
Standard Deviation 2.915
|
4.18 Scores on scale
Standard Deviation 2.169
|
2.68 Scores on scale
Standard Deviation 2.106
|
2.74 Scores on scale
Standard Deviation 1.791
|
|
Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time
Week 32, n=19,14,9,12,12
|
2.01 Scores on scale
Standard Deviation 1.781
|
2.22 Scores on scale
Standard Deviation 2.564
|
3.02 Scores on scale
Standard Deviation 1.199
|
2.43 Scores on scale
Standard Deviation 2.385
|
2.88 Scores on scale
Standard Deviation 2.541
|
|
Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time
Week 36, n=15,13,10,12,13
|
1.46 Scores on scale
Standard Deviation 1.253
|
2.66 Scores on scale
Standard Deviation 2.982
|
2.79 Scores on scale
Standard Deviation 2.013
|
2.68 Scores on scale
Standard Deviation 2.490
|
2.62 Scores on scale
Standard Deviation 1.990
|
|
Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time
Week 44, n=11,11,6,8,8
|
2.28 Scores on scale
Standard Deviation 2.872
|
2.19 Scores on scale
Standard Deviation 2.429
|
2.17 Scores on scale
Standard Deviation 1.824
|
2.18 Scores on scale
Standard Deviation 1.835
|
3.49 Scores on scale
Standard Deviation 2.322
|
|
Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time
Week 4, n=36,37,24,22,27
|
2.43 Scores on scale
Standard Deviation 2.138
|
3.75 Scores on scale
Standard Deviation 2.770
|
3.81 Scores on scale
Standard Deviation 1.737
|
3.01 Scores on scale
Standard Deviation 1.997
|
2.62 Scores on scale
Standard Deviation 1.762
|
|
Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time
Week 8, n=34,30,24,21,23
|
1.97 Scores on scale
Standard Deviation 2.076
|
3.87 Scores on scale
Standard Deviation 2.322
|
3.44 Scores on scale
Standard Deviation 1.763
|
2.85 Scores on scale
Standard Deviation 1.769
|
2.90 Scores on scale
Standard Deviation 2.230
|
|
Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time
Week 12, n=31,28,24,22,22
|
1.97 Scores on scale
Standard Deviation 1.567
|
3.80 Scores on scale
Standard Deviation 2.557
|
3.95 Scores on scale
Standard Deviation 2.200
|
3.20 Scores on scale
Standard Deviation 2.340
|
2.75 Scores on scale
Standard Deviation 2.056
|
|
Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time
Week 24, n=23,20,15,17,16
|
2.63 Scores on scale
Standard Deviation 2.140
|
2.33 Scores on scale
Standard Deviation 1.975
|
3.83 Scores on scale
Standard Deviation 2.447
|
2.85 Scores on scale
Standard Deviation 2.256
|
3.34 Scores on scale
Standard Deviation 1.791
|
|
Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time
Week 40, n=15,11,9,10,10
|
2.05 Scores on scale
Standard Deviation 1.809
|
2.35 Scores on scale
Standard Deviation 2.495
|
3.20 Scores on scale
Standard Deviation 2.329
|
2.24 Scores on scale
Standard Deviation 1.883
|
3.00 Scores on scale
Standard Deviation 2.658
|
|
Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time
Week 48, n=9,8,5,7,5
|
1.81 Scores on scale
Standard Deviation 1.934
|
1.03 Scores on scale
Standard Deviation 1.253
|
2.30 Scores on scale
Standard Deviation 1.515
|
1.86 Scores on scale
Standard Deviation 1.586
|
4.48 Scores on scale
Standard Deviation 3.545
|
|
Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time
Week 52, n=9,5,5,5,4
|
1.10 Scores on scale
Standard Deviation 0.857
|
0.46 Scores on scale
Standard Deviation 0.358
|
2.76 Scores on scale
Standard Deviation 2.668
|
2.44 Scores on scale
Standard Deviation 1.716
|
2.13 Scores on scale
Standard Deviation 2.651
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
The Physician's Global Assessments of Disease Activity was recorded on a VAS of 10 cm ranging from 0 ("none") to 10 ("extremely active").
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time
Week 16, n=26,23,21,16,19
|
0.74 Scores on scale
Standard Deviation 0.895
|
1.54 Scores on scale
Standard Deviation 1.793
|
1.87 Scores on scale
Standard Deviation 2.078
|
1.39 Scores on scale
Standard Deviation 1.830
|
0.67 Scores on scale
Standard Deviation 0.779
|
|
Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time
Week 28, n=17,17,11,12,13
|
0.76 Scores on scale
Standard Deviation 1.068
|
1.43 Scores on scale
Standard Deviation 1.986
|
1.18 Scores on scale
Standard Deviation 2.116
|
0.88 Scores on scale
Standard Deviation 0.586
|
0.85 Scores on scale
Standard Deviation 1.440
|
|
Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time
Week 36, n=13,11,10,11,13
|
0.48 Scores on scale
Standard Deviation 0.660
|
1.12 Scores on scale
Standard Deviation 1.589
|
0.61 Scores on scale
Standard Deviation 0.792
|
0.56 Scores on scale
Standard Deviation 0.408
|
0.75 Scores on scale
Standard Deviation 0.906
|
|
Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time
Week 40, n=13,9,8,9,10
|
0.38 Scores on scale
Standard Deviation 0.395
|
0.77 Scores on scale
Standard Deviation 1.417
|
0.36 Scores on scale
Standard Deviation 0.283
|
0.52 Scores on scale
Standard Deviation 0.531
|
0.57 Scores on scale
Standard Deviation 0.566
|
|
Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time
Week 44, n=10,9,6,8,7
|
0.31 Scores on scale
Standard Deviation 0.228
|
1.07 Scores on scale
Standard Deviation 1.574
|
0.43 Scores on scale
Standard Deviation 0.547
|
0.58 Scores on scale
Standard Deviation 0.740
|
0.87 Scores on scale
Standard Deviation 1.404
|
|
Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time
Week 48, n=7,7,5,6,5
|
0.27 Scores on scale
Standard Deviation 0.446
|
0.31 Scores on scale
Standard Deviation 0.540
|
0.30 Scores on scale
Standard Deviation 0.316
|
0.78 Scores on scale
Standard Deviation 1.482
|
1.60 Scores on scale
Standard Deviation 2.164
|
|
Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time
Week 52, n=9,5,5,4,4
|
0.31 Scores on scale
Standard Deviation 0.434
|
0.10 Scores on scale
Standard Deviation 0.141
|
0.32 Scores on scale
Standard Deviation 0.311
|
1.35 Scores on scale
Standard Deviation 0.947
|
1.80 Scores on scale
Standard Deviation 3.082
|
|
Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time
Baseline, n=42,39,25,26,27
|
2.33 Scores on scale
Standard Deviation 2.101
|
2.95 Scores on scale
Standard Deviation 2.208
|
2.94 Scores on scale
Standard Deviation 2.374
|
3.05 Scores on scale
Standard Deviation 2.501
|
3.25 Scores on scale
Standard Deviation 2.823
|
|
Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time
Week 2, n=36,35,25,20,26
|
1.09 Scores on scale
Standard Deviation 1.373
|
1.52 Scores on scale
Standard Deviation 1.822
|
1.83 Scores on scale
Standard Deviation 1.558
|
1.85 Scores on scale
Standard Deviation 1.879
|
1.76 Scores on scale
Standard Deviation 2.094
|
|
Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time
Week 4, n=33,32,23,21,25
|
0.81 Scores on scale
Standard Deviation 1.191
|
1.44 Scores on scale
Standard Deviation 1.904
|
1.55 Scores on scale
Standard Deviation 1.236
|
0.92 Scores on scale
Standard Deviation 1.125
|
1.02 Scores on scale
Standard Deviation 1.090
|
|
Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time
Week 8, n=33,28,23,20,21
|
1.09 Scores on scale
Standard Deviation 1.508
|
1.30 Scores on scale
Standard Deviation 1.723
|
1.35 Scores on scale
Standard Deviation 1.229
|
0.79 Scores on scale
Standard Deviation 0.798
|
1.14 Scores on scale
Standard Deviation 1.226
|
|
Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time
Week 12, n=29,25,23,18,21
|
1.08 Scores on scale
Standard Deviation 1.486
|
1.81 Scores on scale
Standard Deviation 2.183
|
1.64 Scores on scale
Standard Deviation 1.908
|
1.28 Scores on scale
Standard Deviation 1.629
|
1.47 Scores on scale
Standard Deviation 2.151
|
|
Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time
Week 20, n=25,23,18,17,15
|
0.71 Scores on scale
Standard Deviation 1.189
|
1.42 Scores on scale
Standard Deviation 1.808
|
1.16 Scores on scale
Standard Deviation 1.628
|
0.83 Scores on scale
Standard Deviation 0.882
|
1.27 Scores on scale
Standard Deviation 1.622
|
|
Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time
Week 24, n=20,20,15,15,15
|
0.82 Scores on scale
Standard Deviation 1.089
|
0.68 Scores on scale
Standard Deviation 0.869
|
1.50 Scores on scale
Standard Deviation 1.690
|
1.48 Scores on scale
Standard Deviation 2.003
|
1.37 Scores on scale
Standard Deviation 1.551
|
|
Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time
Week 32, n=19,14,8,11,12
|
0.83 Scores on scale
Standard Deviation 1.320
|
0.67 Scores on scale
Standard Deviation 0.841
|
1.40 Scores on scale
Standard Deviation 1.516
|
1.26 Scores on scale
Standard Deviation 1.546
|
0.89 Scores on scale
Standard Deviation 1.672
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected for analysis of CRP. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for Change from Baseline in serum CRP over time for part A was reported. The Safety set comprised of all randomized participants who received at least 1 dose of SC IP.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time
Week 2,n=38,39,26,24,26
|
-5.07 Milligrams per liter
Standard Deviation 6.616
|
-8.81 Milligrams per liter
Standard Deviation 22.954
|
-5.15 Milligrams per liter
Standard Deviation 8.436
|
1.27 Milligrams per liter
Standard Deviation 13.155
|
1.07 Milligrams per liter
Standard Deviation 6.794
|
|
Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time
Week 4,n=37,38,25,23,27
|
-4.39 Milligrams per liter
Standard Deviation 6.384
|
-9.01 Milligrams per liter
Standard Deviation 23.327
|
-4.09 Milligrams per liter
Standard Deviation 7.169
|
4.91 Milligrams per liter
Standard Deviation 10.503
|
0.76 Milligrams per liter
Standard Deviation 5.511
|
|
Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time
Week 8,n=34,31,24,22,23
|
-4.98 Milligrams per liter
Standard Deviation 6.583
|
-9.94 Milligrams per liter
Standard Deviation 25.685
|
-4.19 Milligrams per liter
Standard Deviation 7.197
|
10.00 Milligrams per liter
Standard Deviation 14.652
|
7.86 Milligrams per liter
Standard Deviation 25.894
|
|
Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time
Week 12,n=32,28,24,21,21
|
-5.08 Milligrams per liter
Standard Deviation 6.690
|
-9.96 Milligrams per liter
Standard Deviation 26.849
|
-4.22 Milligrams per liter
Standard Deviation 7.335
|
14.81 Milligrams per liter
Standard Deviation 18.082
|
4.04 Milligrams per liter
Standard Deviation 9.339
|
|
Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time
Week 16,n=28,26,22,19,18
|
-4.35 Milligrams per liter
Standard Deviation 5.648
|
-10.43 Milligrams per liter
Standard Deviation 27.765
|
-4.48 Milligrams per liter
Standard Deviation 7.621
|
10.53 Milligrams per liter
Standard Deviation 17.303
|
6.99 Milligrams per liter
Standard Deviation 15.503
|
|
Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time
Week 28,n=19,18,12,14,14
|
-5.28 Milligrams per liter
Standard Deviation 6.498
|
-13.42 Milligrams per liter
Standard Deviation 33.182
|
-6.33 Milligrams per liter
Standard Deviation 10.022
|
1.87 Milligrams per liter
Standard Deviation 10.926
|
0.22 Milligrams per liter
Standard Deviation 11.318
|
|
Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time
Week 48,n=9,7,5,8,5
|
-5.91 Milligrams per liter
Standard Deviation 4.993
|
-23.39 Milligrams per liter
Standard Deviation 52.962
|
-2.20 Milligrams per liter
Standard Deviation 1.562
|
6.31 Milligrams per liter
Standard Deviation 20.952
|
8.10 Milligrams per liter
Standard Deviation 18.084
|
|
Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time
Week 52,n=9,5,5,5,4
|
-6.00 Milligrams per liter
Standard Deviation 4.663
|
-7.26 Milligrams per liter
Standard Deviation 9.461
|
-2.20 Milligrams per liter
Standard Deviation 1.575
|
0.64 Milligrams per liter
Standard Deviation 9.453
|
-1.65 Milligrams per liter
Standard Deviation 4.561
|
|
Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time
Week 24,n=23,20,16,17,16
|
-4.38 Milligrams per liter
Standard Deviation 4.640
|
-13.19 Milligrams per liter
Standard Deviation 31.269
|
-5.14 Milligrams per liter
Standard Deviation 8.837
|
5.07 Milligrams per liter
Standard Deviation 13.815
|
6.54 Milligrams per liter
Standard Deviation 20.711
|
|
Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time
Week 32,n=19,15,10,12,13
|
-4.85 Milligrams per liter
Standard Deviation 7.259
|
-14.47 Milligrams per liter
Standard Deviation 36.343
|
-7.15 Milligrams per liter
Standard Deviation 10.875
|
2.61 Milligrams per liter
Standard Deviation 9.835
|
4.37 Milligrams per liter
Standard Deviation 16.277
|
|
Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time
Week 36,n=15,12,10,12,13
|
-4.72 Milligrams per liter
Standard Deviation 4.473
|
-16.28 Milligrams per liter
Standard Deviation 40.531
|
-7.08 Milligrams per liter
Standard Deviation 10.874
|
5.73 Milligrams per liter
Standard Deviation 19.040
|
1.64 Milligrams per liter
Standard Deviation 10.418
|
|
Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time
Week 40,n=15,11,8,10,10
|
-4.72 Milligrams per liter
Standard Deviation 4.374
|
-17.67 Milligrams per liter
Standard Deviation 42.240
|
-4.69 Milligrams per liter
Standard Deviation 8.510
|
6.27 Milligrams per liter
Standard Deviation 21.164
|
2.77 Milligrams per liter
Standard Deviation 13.101
|
|
Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time
Week 44,n=11,11,6,8,9
|
-5.35 Milligrams per liter
Standard Deviation 4.523
|
-17.47 Milligrams per liter
Standard Deviation 42.350
|
-1.90 Milligrams per liter
Standard Deviation 1.456
|
2.80 Milligrams per liter
Standard Deviation 20.439
|
5.13 Milligrams per liter
Standard Deviation 7.292
|
|
Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time
Week 20,n=26,23,19,18,16
|
-4.50 Milligrams per liter
Standard Deviation 5.876
|
-11.67 Milligrams per liter
Standard Deviation 29.422
|
-4.78 Milligrams per liter
Standard Deviation 8.100
|
5.32 Milligrams per liter
Standard Deviation 14.506
|
2.35 Milligrams per liter
Standard Deviation 7.840
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52Population: Safety population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected for analysis of ESR. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for Change from Baseline in ESR over time for part A was reported.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
Week 2,n=37,39,26,24,26
|
-13.05 Millimeters per hour
Standard Deviation 9.885
|
-12.78 Millimeters per hour
Standard Deviation 15.560
|
-14.62 Millimeters per hour
Standard Deviation 16.500
|
-1.33 Millimeters per hour
Standard Deviation 9.323
|
-9.96 Millimeters per hour
Standard Deviation 20.142
|
|
Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
Week 4,n=36,38,25,22,27
|
-12.83 Millimeters per hour
Standard Deviation 9.346
|
-17.41 Millimeters per hour
Standard Deviation 15.867
|
-14.13 Millimeters per hour
Standard Deviation 12.419
|
7.59 Millimeters per hour
Standard Deviation 15.308
|
-5.30 Millimeters per hour
Standard Deviation 22.250
|
|
Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
Week 8,n=33,31,24,22,23
|
-14.21 Millimeters per hour
Standard Deviation 9.927
|
-18.76 Millimeters per hour
Standard Deviation 17.727
|
-15.05 Millimeters per hour
Standard Deviation 14.030
|
6.41 Millimeters per hour
Standard Deviation 12.105
|
1.78 Millimeters per hour
Standard Deviation 27.361
|
|
Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
Week 12,n=32,28,24,22,22
|
-14.97 Millimeters per hour
Standard Deviation 11.361
|
-17.89 Millimeters per hour
Standard Deviation 17.846
|
-14.30 Millimeters per hour
Standard Deviation 13.271
|
20.36 Millimeters per hour
Standard Deviation 18.017
|
-2.55 Millimeters per hour
Standard Deviation 21.498
|
|
Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
Week 16,n=28,26,22,19,19
|
-12.50 Millimeters per hour
Standard Deviation 10.469
|
-17.17 Millimeters per hour
Standard Deviation 17.693
|
-15.37 Millimeters per hour
Standard Deviation 13.956
|
14.21 Millimeters per hour
Standard Deviation 25.189
|
-2.53 Millimeters per hour
Standard Deviation 20.839
|
|
Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
Week 20,n=26,23,18,18,16
|
-13.19 Millimeters per hour
Standard Deviation 9.600
|
-17.07 Millimeters per hour
Standard Deviation 18.498
|
-14.33 Millimeters per hour
Standard Deviation 15.442
|
10.00 Millimeters per hour
Standard Deviation 22.141
|
-5.81 Millimeters per hour
Standard Deviation 23.063
|
|
Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
Week 24,n=23,19,16,17,16
|
-13.63 Millimeters per hour
Standard Deviation 11.209
|
-16.84 Millimeters per hour
Standard Deviation 15.378
|
-14.89 Millimeters per hour
Standard Deviation 14.504
|
7.59 Millimeters per hour
Standard Deviation 21.567
|
-3.06 Millimeters per hour
Standard Deviation 22.389
|
|
Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
Week 28,n=19,18,11,14,14
|
-15.26 Millimeters per hour
Standard Deviation 12.274
|
-19.94 Millimeters per hour
Standard Deviation 20.069
|
-16.84 Millimeters per hour
Standard Deviation 16.856
|
1.50 Millimeters per hour
Standard Deviation 15.854
|
-1.71 Millimeters per hour
Standard Deviation 29.148
|
|
Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
Week 32,n=19,15,10,12,13
|
-13.26 Millimeters per hour
Standard Deviation 17.486
|
-19.80 Millimeters per hour
Standard Deviation 19.266
|
-14.52 Millimeters per hour
Standard Deviation 13.630
|
-2.42 Millimeters per hour
Standard Deviation 20.129
|
-2.85 Millimeters per hour
Standard Deviation 29.493
|
|
Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
Week 36,n=15,12,10,12, 13
|
-14.47 Millimeters per hour
Standard Deviation 11.673
|
-21.25 Millimeters per hour
Standard Deviation 20.855
|
-14.42 Millimeters per hour
Standard Deviation 13.482
|
0.67 Millimeters per hour
Standard Deviation 19.009
|
0.92 Millimeters per hour
Standard Deviation 28.324
|
|
Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
Week 44,n=11,11,6,8,8
|
-12.64 Millimeters per hour
Standard Deviation 10.347
|
-22.18 Millimeters per hour
Standard Deviation 21.409
|
-12.00 Millimeters per hour
Standard Deviation 13.520
|
4.88 Millimeters per hour
Standard Deviation 18.256
|
2.88 Millimeters per hour
Standard Deviation 21.860
|
|
Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
Week 52,n=9,5,5,5,4
|
-14.78 Millimeters per hour
Standard Deviation 11.692
|
-24.60 Millimeters per hour
Standard Deviation 17.700
|
-12.80 Millimeters per hour
Standard Deviation 15.385
|
-4.60 Millimeters per hour
Standard Deviation 10.431
|
1.25 Millimeters per hour
Standard Deviation 15.042
|
|
Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
Week 40,n=15,11,9,10,10
|
-14.40 Millimeters per hour
Standard Deviation 12.070
|
-22.27 Millimeters per hour
Standard Deviation 21.873
|
-11.24 Millimeters per hour
Standard Deviation 13.277
|
9.80 Millimeters per hour
Standard Deviation 28.840
|
-2.60 Millimeters per hour
Standard Deviation 27.818
|
|
Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
Week 48,n=9,8,5,8,5
|
-15.33 Millimeters per hour
Standard Deviation 11.822
|
-25.63 Millimeters per hour
Standard Deviation 24.372
|
-14.00 Millimeters per hour
Standard Deviation 14.335
|
4.50 Millimeters per hour
Standard Deviation 24.308
|
8.60 Millimeters per hour
Standard Deviation 25.205
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Safety Population.
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs have been reported.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs
Any AE
|
41 Participants
|
36 Participants
|
25 Participants
|
26 Participants
|
24 Participants
|
|
Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs
Any SAE
|
8 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
|
Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs
Any Corticosteroid related AE
|
18 Participants
|
21 Participants
|
15 Participants
|
13 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52Population: Safety Population Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)..
SBP and DBP were measured in semi-supine position after 5 minutes rest at indicated time points. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP,Week 2,n=37,39,26,24,27
|
-0.9 Millimeters of mercury
Standard Deviation 13.11
|
3.5 Millimeters of mercury
Standard Deviation 13.97
|
-2.1 Millimeters of mercury
Standard Deviation 17.19
|
5.7 Millimeters of mercury
Standard Deviation 12.67
|
-0.9 Millimeters of mercury
Standard Deviation 15.63
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP,Week 4,n=37,37,25,23,27
|
-0.9 Millimeters of mercury
Standard Deviation 15.17
|
0.2 Millimeters of mercury
Standard Deviation 15.99
|
-4.7 Millimeters of mercury
Standard Deviation 15.00
|
-2.2 Millimeters of mercury
Standard Deviation 14.60
|
-3.4 Millimeters of mercury
Standard Deviation 14.25
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP,Week 12,n=32,29,24,22,22
|
-2.3 Millimeters of mercury
Standard Deviation 15.19
|
-2.4 Millimeters of mercury
Standard Deviation 17.15
|
-6.2 Millimeters of mercury
Standard Deviation 13.45
|
1.4 Millimeters of mercury
Standard Deviation 12.97
|
-6.1 Millimeters of mercury
Standard Deviation 19.31
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP,Week 16,n=28,26,22,19,19
|
-6.0 Millimeters of mercury
Standard Deviation 15.39
|
-5.1 Millimeters of mercury
Standard Deviation 18.28
|
-3.0 Millimeters of mercury
Standard Deviation 20.22
|
1.9 Millimeters of mercury
Standard Deviation 17.51
|
-6.4 Millimeters of mercury
Standard Deviation 12.73
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP,Week 20,n=26,23,19,18,16
|
-6.7 Millimeters of mercury
Standard Deviation 10.73
|
-0.7 Millimeters of mercury
Standard Deviation 14.09
|
-3.4 Millimeters of mercury
Standard Deviation 15.39
|
-1.7 Millimeters of mercury
Standard Deviation 17.16
|
-9.4 Millimeters of mercury
Standard Deviation 21.44
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP,Week 24,n=23,21,16,17,16
|
-5.2 Millimeters of mercury
Standard Deviation 12.65
|
-2.5 Millimeters of mercury
Standard Deviation 15.46
|
-5.6 Millimeters of mercury
Standard Deviation 16.55
|
-2.6 Millimeters of mercury
Standard Deviation 18.75
|
-8.6 Millimeters of mercury
Standard Deviation 15.65
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP,Week 44,n=11,11,6,8,9
|
-12.7 Millimeters of mercury
Standard Deviation 17.66
|
-4.2 Millimeters of mercury
Standard Deviation 19.22
|
2.7 Millimeters of mercury
Standard Deviation 13.26
|
2.9 Millimeters of mercury
Standard Deviation 15.99
|
1.8 Millimeters of mercury
Standard Deviation 13.91
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP,Week 8,n=34,32,24,22,23
|
2.1 Millimeters of mercury
Standard Deviation 8.47
|
-1.3 Millimeters of mercury
Standard Deviation 7.62
|
-4.0 Millimeters of mercury
Standard Deviation 12.26
|
2.6 Millimeters of mercury
Standard Deviation 11.27
|
-5.6 Millimeters of mercury
Standard Deviation 11.83
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP,Week 12,n=32,29,24,22,22
|
1.0 Millimeters of mercury
Standard Deviation 9.60
|
2.0 Millimeters of mercury
Standard Deviation 12.35
|
-4.7 Millimeters of mercury
Standard Deviation 12.14
|
1.3 Millimeters of mercury
Standard Deviation 10.58
|
-2.5 Millimeters of mercury
Standard Deviation 11.16
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP,Week 16,n=28,26,22,19,19
|
0.2 Millimeters of mercury
Standard Deviation 7.48
|
-2.5 Millimeters of mercury
Standard Deviation 11.58
|
-3.1 Millimeters of mercury
Standard Deviation 12.80
|
-1.3 Millimeters of mercury
Standard Deviation 10.64
|
-3.4 Millimeters of mercury
Standard Deviation 7.97
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP,Week 20,n=26,23,19,18,16
|
-0.9 Millimeters of mercury
Standard Deviation 7.66
|
1.4 Millimeters of mercury
Standard Deviation 12.47
|
-3.2 Millimeters of mercury
Standard Deviation 16.21
|
-2.0 Millimeters of mercury
Standard Deviation 9.06
|
-2.1 Millimeters of mercury
Standard Deviation 10.98
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP,Week 32,n=19,15,10,12,13
|
-4.2 Millimeters of mercury
Standard Deviation 7.50
|
-2.3 Millimeters of mercury
Standard Deviation 12.92
|
-6.9 Millimeters of mercury
Standard Deviation 25.47
|
-1.2 Millimeters of mercury
Standard Deviation 11.17
|
-5.8 Millimeters of mercury
Standard Deviation 9.09
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP,Week 36,n=15,13,10,12,13
|
-0.6 Millimeters of mercury
Standard Deviation 8.92
|
-5.1 Millimeters of mercury
Standard Deviation 9.89
|
-5.6 Millimeters of mercury
Standard Deviation 17.02
|
-1.2 Millimeters of mercury
Standard Deviation 13.31
|
-2.7 Millimeters of mercury
Standard Deviation 13.05
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP,Week 40,n=15,11,9,10,10
|
-6.9 Millimeters of mercury
Standard Deviation 12.41
|
2.6 Millimeters of mercury
Standard Deviation 11.88
|
-8.0 Millimeters of mercury
Standard Deviation 21.60
|
-2.0 Millimeters of mercury
Standard Deviation 14.07
|
-6.1 Millimeters of mercury
Standard Deviation 11.97
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP,Week 44,n=11,11,6,8,9
|
-2.7 Millimeters of mercury
Standard Deviation 12.10
|
-6.5 Millimeters of mercury
Standard Deviation 14.56
|
-2.5 Millimeters of mercury
Standard Deviation 23.89
|
-1.5 Millimeters of mercury
Standard Deviation 8.28
|
1.3 Millimeters of mercury
Standard Deviation 11.36
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP,Week 8,n=34,32,24,22,23
|
0.3 Millimeters of mercury
Standard Deviation 14.33
|
-3.9 Millimeters of mercury
Standard Deviation 17.17
|
-3.5 Millimeters of mercury
Standard Deviation 15.73
|
-0.8 Millimeters of mercury
Standard Deviation 18.94
|
-8.3 Millimeters of mercury
Standard Deviation 21.05
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP,Week 28,n=19,18,12,14,14
|
-8.8 Millimeters of mercury
Standard Deviation 12.87
|
-4.2 Millimeters of mercury
Standard Deviation 20.49
|
-0.1 Millimeters of mercury
Standard Deviation 14.76
|
6.4 Millimeters of mercury
Standard Deviation 19.31
|
-2.6 Millimeters of mercury
Standard Deviation 17.71
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP,Week 32,n=19,15,10,12,13
|
-10.7 Millimeters of mercury
Standard Deviation 13.96
|
-3.7 Millimeters of mercury
Standard Deviation 15.03
|
-7.4 Millimeters of mercury
Standard Deviation 11.80
|
3.4 Millimeters of mercury
Standard Deviation 14.99
|
-8.8 Millimeters of mercury
Standard Deviation 14.80
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP,Week 36,n=15,13,10,12,13
|
-6.2 Millimeters of mercury
Standard Deviation 13.92
|
-8.0 Millimeters of mercury
Standard Deviation 15.80
|
-6.8 Millimeters of mercury
Standard Deviation 12.10
|
-0.6 Millimeters of mercury
Standard Deviation 20.46
|
-2.5 Millimeters of mercury
Standard Deviation 16.13
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP,Week 40,n=15,11,9,10,10
|
-11.9 Millimeters of mercury
Standard Deviation 11.75
|
0.9 Millimeters of mercury
Standard Deviation 13.14
|
-4.8 Millimeters of mercury
Standard Deviation 14.17
|
2.1 Millimeters of mercury
Standard Deviation 19.31
|
-7.4 Millimeters of mercury
Standard Deviation 20.14
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP,Week 48,n=9,8,5,8,5
|
-13.6 Millimeters of mercury
Standard Deviation 11.85
|
-0.4 Millimeters of mercury
Standard Deviation 9.44
|
-3.6 Millimeters of mercury
Standard Deviation 28.13
|
8.8 Millimeters of mercury
Standard Deviation 14.15
|
4.8 Millimeters of mercury
Standard Deviation 15.51
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP,Week 52,n=9,5,5,5,4
|
-8.1 Millimeters of mercury
Standard Deviation 15.85
|
1.2 Millimeters of mercury
Standard Deviation 14.46
|
2.2 Millimeters of mercury
Standard Deviation 19.52
|
2.2 Millimeters of mercury
Standard Deviation 18.46
|
-3.8 Millimeters of mercury
Standard Deviation 12.34
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP,Week 2,n=37,39,26,24,27
|
0.3 Millimeters of mercury
Standard Deviation 7.41
|
1.2 Millimeters of mercury
Standard Deviation 10.05
|
-2.3 Millimeters of mercury
Standard Deviation 14.00
|
2.4 Millimeters of mercury
Standard Deviation 9.85
|
-2.2 Millimeters of mercury
Standard Deviation 9.22
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP,Week 4,n=37,37,25,23,27
|
1.8 Millimeters of mercury
Standard Deviation 8.85
|
1.5 Millimeters of mercury
Standard Deviation 10.24
|
-4.1 Millimeters of mercury
Standard Deviation 13.22
|
0.1 Millimeters of mercury
Standard Deviation 11.66
|
-3.0 Millimeters of mercury
Standard Deviation 10.22
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP,Week 24,n=23,21,16,17,16
|
1.3 Millimeters of mercury
Standard Deviation 8.72
|
-0.6 Millimeters of mercury
Standard Deviation 12.85
|
-2.7 Millimeters of mercury
Standard Deviation 11.77
|
-3.3 Millimeters of mercury
Standard Deviation 10.21
|
-3.1 Millimeters of mercury
Standard Deviation 9.27
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP,Week 28,n=19,18,12,14,14
|
-3.1 Millimeters of mercury
Standard Deviation 9.39
|
-2.2 Millimeters of mercury
Standard Deviation 10.05
|
-4.3 Millimeters of mercury
Standard Deviation 15.80
|
0.1 Millimeters of mercury
Standard Deviation 13.87
|
-1.9 Millimeters of mercury
Standard Deviation 10.37
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP,Week 48,n=9,8,5,8,5
|
-5.6 Millimeters of mercury
Standard Deviation 11.79
|
-2.3 Millimeters of mercury
Standard Deviation 11.42
|
-2.0 Millimeters of mercury
Standard Deviation 16.00
|
-3.4 Millimeters of mercury
Standard Deviation 12.75
|
0.6 Millimeters of mercury
Standard Deviation 8.47
|
|
Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP,Week 52,n=9,5,5,5,4
|
0.2 Millimeters of mercury
Standard Deviation 12.55
|
1.8 Millimeters of mercury
Standard Deviation 10.23
|
2.2 Millimeters of mercury
Standard Deviation 3.35
|
1.4 Millimeters of mercury
Standard Deviation 11.89
|
0.5 Millimeters of mercury
Standard Deviation 5.92
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)
Pulse rate was measured in semi-supine position after 5 minutes rest at Baseline and up to 52 weeks. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Change From Baseline in Pulse Rate
Week 2, ,n=37,39,25,24,27
|
-1.9 Beats per minute
Standard Deviation 8.07
|
-2.1 Beats per minute
Standard Deviation 8.93
|
1.8 Beats per minute
Standard Deviation 10.40
|
-0.4 Beats per minute
Standard Deviation 12.34
|
-1.6 Beats per minute
Standard Deviation 9.79
|
|
Part A: Change From Baseline in Pulse Rate
Week 4,n=37,37,25,22,27
|
0.2 Beats per minute
Standard Deviation 8.82
|
-1.4 Beats per minute
Standard Deviation 8.94
|
-2.4 Beats per minute
Standard Deviation 9.42
|
2.2 Beats per minute
Standard Deviation 13.39
|
-1.9 Beats per minute
Standard Deviation 10.33
|
|
Part A: Change From Baseline in Pulse Rate
Week 12,n=32,29,23,22,22
|
-3.8 Beats per minute
Standard Deviation 8.50
|
-1.2 Beats per minute
Standard Deviation 13.62
|
-0.8 Beats per minute
Standard Deviation 8.35
|
4.5 Beats per minute
Standard Deviation 14.54
|
-2.7 Beats per minute
Standard Deviation 10.95
|
|
Part A: Change From Baseline in Pulse Rate
Week 20,n=26,23,19,18,16
|
-3.0 Beats per minute
Standard Deviation 9.75
|
0.2 Beats per minute
Standard Deviation 11.35
|
-0.7 Beats per minute
Standard Deviation 12.62
|
1.0 Beats per minute
Standard Deviation 13.76
|
-4.0 Beats per minute
Standard Deviation 12.54
|
|
Part A: Change From Baseline in Pulse Rate
Week 24,n=23,21,16,17,16
|
-2.1 Beats per minute
Standard Deviation 9.29
|
-3.5 Beats per minute
Standard Deviation 11.18
|
0.7 Beats per minute
Standard Deviation 14.13
|
0.1 Beats per minute
Standard Deviation 12.76
|
2.7 Beats per minute
Standard Deviation 8.27
|
|
Part A: Change From Baseline in Pulse Rate
Week 44,n=11,11,6,8,9
|
-7.1 Beats per minute
Standard Deviation 8.01
|
-3.4 Beats per minute
Standard Deviation 15.86
|
-8.3 Beats per minute
Standard Deviation 13.41
|
4.3 Beats per minute
Standard Deviation 15.34
|
-3.4 Beats per minute
Standard Deviation 8.57
|
|
Part A: Change From Baseline in Pulse Rate
Week 48,n=9,8,5,8,5
|
-8.2 Beats per minute
Standard Deviation 7.36
|
-9.3 Beats per minute
Standard Deviation 8.76
|
-7.2 Beats per minute
Standard Deviation 10.47
|
-1.9 Beats per minute
Standard Deviation 11.47
|
0.0 Beats per minute
Standard Deviation 16.72
|
|
Part A: Change From Baseline in Pulse Rate
Week 52,n=9,5,5,5,4
|
-5.0 Beats per minute
Standard Deviation 12.97
|
-11.0 Beats per minute
Standard Deviation 3.74
|
-4.0 Beats per minute
Standard Deviation 15.89
|
6.8 Beats per minute
Standard Deviation 6.34
|
-5.3 Beats per minute
Standard Deviation 12.04
|
|
Part A: Change From Baseline in Pulse Rate
Week 8,n=34,32,24,22,23
|
-1.1 Beats per minute
Standard Deviation 10.23
|
-3.2 Beats per minute
Standard Deviation 11.42
|
-3.1 Beats per minute
Standard Deviation 8.80
|
4.3 Beats per minute
Standard Deviation 12.36
|
0.5 Beats per minute
Standard Deviation 11.06
|
|
Part A: Change From Baseline in Pulse Rate
Week 16,n=28,26,22,19,19
|
-3.4 Beats per minute
Standard Deviation 10.79
|
0.3 Beats per minute
Standard Deviation 9.06
|
-5.3 Beats per minute
Standard Deviation 10.32
|
0.3 Beats per minute
Standard Deviation 15.04
|
-2.2 Beats per minute
Standard Deviation 10.76
|
|
Part A: Change From Baseline in Pulse Rate
Week 28,n=19,18,12,14,14
|
-1.4 Beats per minute
Standard Deviation 10.33
|
-1.2 Beats per minute
Standard Deviation 9.21
|
-3.5 Beats per minute
Standard Deviation 13.26
|
0.1 Beats per minute
Standard Deviation 13.24
|
0.5 Beats per minute
Standard Deviation 10.60
|
|
Part A: Change From Baseline in Pulse Rate
Week 32,n=19,15,10,12,13
|
-1.3 Beats per minute
Standard Deviation 8.20
|
-4.7 Beats per minute
Standard Deviation 8.50
|
-2.2 Beats per minute
Standard Deviation 10.78
|
-0.8 Beats per minute
Standard Deviation 16.10
|
-0.6 Beats per minute
Standard Deviation 12.58
|
|
Part A: Change From Baseline in Pulse Rate
Week 36,n=15,13,10,12,13
|
-5.9 Beats per minute
Standard Deviation 9.79
|
-5.1 Beats per minute
Standard Deviation 9.06
|
-4.5 Beats per minute
Standard Deviation 9.12
|
-0.5 Beats per minute
Standard Deviation 12.22
|
-3.2 Beats per minute
Standard Deviation 9.83
|
|
Part A: Change From Baseline in Pulse Rate
Week 40,n=15,11,9,10,10
|
-3.9 Beats per minute
Standard Deviation 5.64
|
-3.0 Beats per minute
Standard Deviation 11.93
|
-3.4 Beats per minute
Standard Deviation 10.57
|
3.3 Beats per minute
Standard Deviation 12.83
|
-3.8 Beats per minute
Standard Deviation 14.09
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)
Temperature was measured in semi-supine position after 5 minutes rest at Baseline and up to 52 weeks. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Change From Baseline in Temperature
Week 2, ,n=37,39,26,24,27
|
-0.11 Celsius
Standard Deviation 0.269
|
-0.04 Celsius
Standard Deviation 0.336
|
0.03 Celsius
Standard Deviation 0.433
|
-0.16 Celsius
Standard Deviation 0.421
|
0.10 Celsius
Standard Deviation 0.449
|
|
Part A: Change From Baseline in Temperature
Week 4,n=37,37,25,23,27
|
-0.12 Celsius
Standard Deviation 0.345
|
0.01 Celsius
Standard Deviation 0.407
|
0.04 Celsius
Standard Deviation 0.399
|
-0.10 Celsius
Standard Deviation 0.387
|
0.11 Celsius
Standard Deviation 0.340
|
|
Part A: Change From Baseline in Temperature
Week 8,n=34,32,23,22,23
|
-0.04 Celsius
Standard Deviation 0.400
|
-0.09 Celsius
Standard Deviation 0.432
|
-0.07 Celsius
Standard Deviation 0.553
|
0.04 Celsius
Standard Deviation 0.579
|
0.19 Celsius
Standard Deviation 0.425
|
|
Part A: Change From Baseline in Temperature
Week 12,n=32,29,24,22,22
|
-0.08 Celsius
Standard Deviation 0.461
|
-0.11 Celsius
Standard Deviation 0.367
|
0.01 Celsius
Standard Deviation 0.444
|
-0.15 Celsius
Standard Deviation 0.494
|
0.09 Celsius
Standard Deviation 0.450
|
|
Part A: Change From Baseline in Temperature
Week 16,n=28,26,22,19,19
|
-0.08 Celsius
Standard Deviation 0.313
|
-0.05 Celsius
Standard Deviation 0.392
|
0.04 Celsius
Standard Deviation 0.316
|
-0.21 Celsius
Standard Deviation 0.664
|
0.09 Celsius
Standard Deviation 0.317
|
|
Part A: Change From Baseline in Temperature
Week 20,n=26,23,19,18,16
|
0.03 Celsius
Standard Deviation 0.428
|
-0.05 Celsius
Standard Deviation 0.483
|
-0.12 Celsius
Standard Deviation 0.651
|
-0.07 Celsius
Standard Deviation 0.355
|
0.05 Celsius
Standard Deviation 0.395
|
|
Part A: Change From Baseline in Temperature
Week 24,n=23,21,16,17,16
|
0.03 Celsius
Standard Deviation 0.389
|
-0.11 Celsius
Standard Deviation 0.255
|
-0.11 Celsius
Standard Deviation 0.558
|
-0.26 Celsius
Standard Deviation 0.476
|
0.04 Celsius
Standard Deviation 0.441
|
|
Part A: Change From Baseline in Temperature
Week 32,n=19,15,10,12,13
|
-0.01 Celsius
Standard Deviation 0.515
|
-0.07 Celsius
Standard Deviation 0.349
|
0.28 Celsius
Standard Deviation 0.418
|
-0.13 Celsius
Standard Deviation 0.367
|
0.01 Celsius
Standard Deviation 0.364
|
|
Part A: Change From Baseline in Temperature
Week 36,n=15,13,9,12,13
|
-0.09 Celsius
Standard Deviation 0.406
|
-0.11 Celsius
Standard Deviation 0.569
|
-0.10 Celsius
Standard Deviation 0.391
|
-0.09 Celsius
Standard Deviation 0.390
|
-0.08 Celsius
Standard Deviation 0.367
|
|
Part A: Change From Baseline in Temperature
Week 40,n=15,11,9,10,10
|
0.08 Celsius
Standard Deviation 0.426
|
-0.03 Celsius
Standard Deviation 0.454
|
0.18 Celsius
Standard Deviation 0.438
|
-0.05 Celsius
Standard Deviation 0.334
|
-0.05 Celsius
Standard Deviation 0.306
|
|
Part A: Change From Baseline in Temperature
Week 44,n=11,11,6,8,9
|
-0.14 Celsius
Standard Deviation 0.347
|
-0.06 Celsius
Standard Deviation 0.391
|
-0.03 Celsius
Standard Deviation 0.314
|
0.00 Celsius
Standard Deviation 0.438
|
-0.08 Celsius
Standard Deviation 0.396
|
|
Part A: Change From Baseline in Temperature
Week 48,n=9,8,5,8,5
|
-0.22 Celsius
Standard Deviation 0.233
|
-0.05 Celsius
Standard Deviation 0.510
|
-0.14 Celsius
Standard Deviation 0.498
|
-0.01 Celsius
Standard Deviation 0.280
|
-0.08 Celsius
Standard Deviation 0.559
|
|
Part A: Change From Baseline in Temperature
Week 28,n=19,18,12,13,14
|
0.03 Celsius
Standard Deviation 0.444
|
-0.07 Celsius
Standard Deviation 0.517
|
-0.09 Celsius
Standard Deviation 0.683
|
-0.16 Celsius
Standard Deviation 0.479
|
-0.06 Celsius
Standard Deviation 0.282
|
|
Part A: Change From Baseline in Temperature
Week 52,n=9,5,5,5,4
|
-0.08 Celsius
Standard Deviation 0.291
|
-0.32 Celsius
Standard Deviation 0.286
|
0.14 Celsius
Standard Deviation 0.230
|
0.02 Celsius
Standard Deviation 0.409
|
-0.08 Celsius
Standard Deviation 0.814
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)
Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Eosinophils,Week 2,n=37,36,24,23,25
|
0.019 Giga cells per liter
Standard Deviation 0.0543
|
0.001 Giga cells per liter
Standard Deviation 0.0690
|
0.010 Giga cells per liter
Standard Deviation 0.0433
|
0.015 Giga cells per liter
Standard Deviation 0.0557
|
0.062 Giga cells per liter
Standard Deviation 0.2084
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Eosinophils,Week 4,n=36,37,24,22,26
|
0.043 Giga cells per liter
Standard Deviation 0.0934
|
0.035 Giga cells per liter
Standard Deviation 0.1238
|
0.012 Giga cells per liter
Standard Deviation 0.0719
|
0.023 Giga cells per liter
Standard Deviation 0.0617
|
0.030 Giga cells per liter
Standard Deviation 0.1164
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Eosinophils,Week 8,n=34,29,22,22,21
|
0.056 Giga cells per liter
Standard Deviation 0.0959
|
0.102 Giga cells per liter
Standard Deviation 0.1634
|
0.054 Giga cells per liter
Standard Deviation 0.1036
|
0.048 Giga cells per liter
Standard Deviation 0.1498
|
0.010 Giga cells per liter
Standard Deviation 0.0591
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Eosinophils,Week 12,n=31,28,23,22,22
|
0.077 Giga cells per liter
Standard Deviation 0.1128
|
0.155 Giga cells per liter
Standard Deviation 0.1971
|
0.090 Giga cells per liter
Standard Deviation 0.0860
|
0.090 Giga cells per liter
Standard Deviation 0.1684
|
0.030 Giga cells per liter
Standard Deviation 0.0548
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Eosinophils,Week 16,n=27,26,20,19,19
|
0.097 Giga cells per liter
Standard Deviation 0.1307
|
0.162 Giga cells per liter
Standard Deviation 0.2170
|
0.117 Giga cells per liter
Standard Deviation 0.1772
|
0.067 Giga cells per liter
Standard Deviation 0.1148
|
0.067 Giga cells per liter
Standard Deviation 0.1746
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Eosinophils,Week 24,n=22,21,16,16,16
|
0.210 Giga cells per liter
Standard Deviation 0.4418
|
0.109 Giga cells per liter
Standard Deviation 0.1590
|
0.109 Giga cells per liter
Standard Deviation 0.1094
|
0.089 Giga cells per liter
Standard Deviation 0.2392
|
0.051 Giga cells per liter
Standard Deviation 0.0676
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Eosinophils,Week 32,n=19,15,10,12,13
|
0.244 Giga cells per liter
Standard Deviation 0.3707
|
0.069 Giga cells per liter
Standard Deviation 0.1580
|
0.092 Giga cells per liter
Standard Deviation 0.1253
|
0.038 Giga cells per liter
Standard Deviation 0.0597
|
0.056 Giga cells per liter
Standard Deviation 0.0733
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Eosinophils,Week 40,n=14,11,8,10,10
|
0.191 Giga cells per liter
Standard Deviation 0.2175
|
0.075 Giga cells per liter
Standard Deviation 0.1924
|
0.104 Giga cells per liter
Standard Deviation 0.1161
|
0.065 Giga cells per liter
Standard Deviation 0.0737
|
0.071 Giga cells per liter
Standard Deviation 0.1140
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Eosinophils,Week 44,n=11,10,6,7,9
|
0.144 Giga cells per liter
Standard Deviation 0.1952
|
0.045 Giga cells per liter
Standard Deviation 0.1329
|
0.165 Giga cells per liter
Standard Deviation 0.1564
|
0.024 Giga cells per liter
Standard Deviation 0.0541
|
0.066 Giga cells per liter
Standard Deviation 0.0600
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Lymphocytes,Week 28,n=18,18,11,14,13
|
-0.614 Giga cells per liter
Standard Deviation 1.5450
|
-0.273 Giga cells per liter
Standard Deviation 1.3296
|
-0.192 Giga cells per liter
Standard Deviation 0.7271
|
-0.258 Giga cells per liter
Standard Deviation 1.0211
|
-0.565 Giga cells per liter
Standard Deviation 1.0397
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Eosinophils,Week 48,n=9,8,4,8,5
|
0.091 Giga cells per liter
Standard Deviation 0.0664
|
0.059 Giga cells per liter
Standard Deviation 0.1561
|
0.233 Giga cells per liter
Standard Deviation 0.2387
|
0.028 Giga cells per liter
Standard Deviation 0.0489
|
0.030 Giga cells per liter
Standard Deviation 0.0604
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Leukocytes,Week 2,n=37,38,24,24,25
|
-3.12 Giga cells per liter
Standard Deviation 2.268
|
-3.63 Giga cells per liter
Standard Deviation 1.971
|
-3.32 Giga cells per liter
Standard Deviation 2.816
|
-0.76 Giga cells per liter
Standard Deviation 2.145
|
0.34 Giga cells per liter
Standard Deviation 2.238
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Leukocytes,Week 4,n=36,37,24,22,26
|
-3.66 Giga cells per liter
Standard Deviation 2.621
|
-4.76 Giga cells per liter
Standard Deviation 2.411
|
-4.07 Giga cells per liter
Standard Deviation 2.157
|
-1.64 Giga cells per liter
Standard Deviation 2.247
|
-0.16 Giga cells per liter
Standard Deviation 2.330
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Leukocytes,Week 20,n=25,23,18,18,16
|
-5.24 Giga cells per liter
Standard Deviation 1.950
|
-5.20 Giga cells per liter
Standard Deviation 3.104
|
-5.40 Giga cells per liter
Standard Deviation 2.414
|
-3.24 Giga cells per liter
Standard Deviation 3.592
|
-1.71 Giga cells per liter
Standard Deviation 2.840
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Leukocytes,Week 40,n=14,11,8,10,10
|
-6.14 Giga cells per liter
Standard Deviation 1.987
|
-7.10 Giga cells per liter
Standard Deviation 2.534
|
-6.46 Giga cells per liter
Standard Deviation 2.130
|
-3.18 Giga cells per liter
Standard Deviation 3.662
|
-2.23 Giga cells per liter
Standard Deviation 3.142
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Lymphocytes,Week 4,n=36,37,24,22,26
|
0.027 Giga cells per liter
Standard Deviation 1.2460
|
-0.255 Giga cells per liter
Standard Deviation 1.2225
|
0.057 Giga cells per liter
Standard Deviation 1.2338
|
-0.002 Giga cells per liter
Standard Deviation 0.7340
|
-0.382 Giga cells per liter
Standard Deviation 1.0808
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Lymphocytes,Week 8,n=34,29,22,22,21
|
-0.191 Giga cells per liter
Standard Deviation 1.3361
|
-0.411 Giga cells per liter
Standard Deviation 1.2086
|
-0.067 Giga cells per liter
Standard Deviation 1.2814
|
-0.049 Giga cells per liter
Standard Deviation 1.0832
|
-0.516 Giga cells per liter
Standard Deviation 0.8562
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Lymphocytes,Week 48,n=9,8,4,8,5
|
-1.258 Giga cells per liter
Standard Deviation 1.2063
|
-0.923 Giga cells per liter
Standard Deviation 1.4811
|
0.118 Giga cells per liter
Standard Deviation 1.0588
|
-0.576 Giga cells per liter
Standard Deviation 1.1994
|
-0.510 Giga cells per liter
Standard Deviation 1.1450
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Neutrophils,Week 16,n=27,26,20,19,19
|
-4.933 Giga cells per liter
Standard Deviation 2.4430
|
-4.929 Giga cells per liter
Standard Deviation 3.7907
|
-5.358 Giga cells per liter
Standard Deviation 2.2367
|
-2.766 Giga cells per liter
Standard Deviation 3.3212
|
-0.263 Giga cells per liter
Standard Deviation 3.3610
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Neutrophils,Week 20,n=25,22,18,17,16
|
-4.867 Giga cells per liter
Standard Deviation 2.3110
|
-4.997 Giga cells per liter
Standard Deviation 3.0763
|
-5.168 Giga cells per liter
Standard Deviation 2.4898
|
-2.856 Giga cells per liter
Standard Deviation 4.0311
|
-1.355 Giga cells per liter
Standard Deviation 3.3883
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Neutrophils,Week 24,n=22,21,16,16,16
|
-4.985 Giga cells per liter
Standard Deviation 3.5051
|
-6.257 Giga cells per liter
Standard Deviation 2.7551
|
-5.030 Giga cells per liter
Standard Deviation 1.9579
|
-2.570 Giga cells per liter
Standard Deviation 4.2089
|
-1.342 Giga cells per liter
Standard Deviation 3.1038
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Neutrophils,Week 28,n=18,18,11,14,13
|
-5.076 Giga cells per liter
Standard Deviation 2.3415
|
-5.729 Giga cells per liter
Standard Deviation 3.1699
|
-4.469 Giga cells per liter
Standard Deviation 2.1333
|
-2.764 Giga cells per liter
Standard Deviation 3.5787
|
-1.503 Giga cells per liter
Standard Deviation 4.3502
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Neutrophils,Week 32,n=19,15,10,12,13
|
-5.357 Giga cells per liter
Standard Deviation 2.5525
|
-5.153 Giga cells per liter
Standard Deviation 3.1939
|
-4.840 Giga cells per liter
Standard Deviation 1.9387
|
-3.006 Giga cells per liter
Standard Deviation 3.7915
|
-2.018 Giga cells per liter
Standard Deviation 3.5674
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Neutrophils,Week 44,n=11,10,6,7,9
|
-5.432 Giga cells per liter
Standard Deviation 2.5555
|
-5.799 Giga cells per liter
Standard Deviation 3.1785
|
-6.185 Giga cells per liter
Standard Deviation 1.3944
|
-1.807 Giga cells per liter
Standard Deviation 4.5472
|
-2.883 Giga cells per liter
Standard Deviation 3.8690
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Neutrophils,Week 48,n=9,8,4,8,5
|
-5.628 Giga cells per liter
Standard Deviation 2.3471
|
-6.396 Giga cells per liter
Standard Deviation 3.4832
|
-6.790 Giga cells per liter
Standard Deviation 1.6060
|
-2.160 Giga cells per liter
Standard Deviation 3.3843
|
-2.650 Giga cells per liter
Standard Deviation 4.0017
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Neutrophils,Week 52,n=8,5,5,5,4
|
-5.520 Giga cells per liter
Standard Deviation 2.7316
|
-6.774 Giga cells per liter
Standard Deviation 2.6817
|
-6.256 Giga cells per liter
Standard Deviation 1.8929
|
-4.214 Giga cells per liter
Standard Deviation 3.6948
|
-2.990 Giga cells per liter
Standard Deviation 4.8629
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Platelets,Week 2,n=37,38,24,23,25
|
-39.0 Giga cells per liter
Standard Deviation 39.46
|
-49.2 Giga cells per liter
Standard Deviation 52.77
|
-41.1 Giga cells per liter
Standard Deviation 40.29
|
-1.9 Giga cells per liter
Standard Deviation 37.57
|
-4.3 Giga cells per liter
Standard Deviation 49.32
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Platelets,Week 8,n=34,29,22,22,21
|
-37.3 Giga cells per liter
Standard Deviation 31.22
|
-72.2 Giga cells per liter
Standard Deviation 75.77
|
-53.3 Giga cells per liter
Standard Deviation 37.10
|
14.2 Giga cells per liter
Standard Deviation 45.62
|
15.7 Giga cells per liter
Standard Deviation 57.21
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Platelets,Week 12,n=31,28,23,22,22
|
-51.2 Giga cells per liter
Standard Deviation 33.25
|
-74.0 Giga cells per liter
Standard Deviation 52.17
|
-55.4 Giga cells per liter
Standard Deviation 38.89
|
17.8 Giga cells per liter
Standard Deviation 50.58
|
4.3 Giga cells per liter
Standard Deviation 55.14
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Platelets,Week 16,n=27,26,20,19,19
|
-53.8 Giga cells per liter
Standard Deviation 33.54
|
-69.9 Giga cells per liter
Standard Deviation 53.79
|
-54.8 Giga cells per liter
Standard Deviation 39.71
|
12.4 Giga cells per liter
Standard Deviation 52.98
|
13.8 Giga cells per liter
Standard Deviation 60.11
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Platelets,Week 28,n=18,18,11,14,13
|
-70.2 Giga cells per liter
Standard Deviation 45.09
|
-61.3 Giga cells per liter
Standard Deviation 54.34
|
-50.6 Giga cells per liter
Standard Deviation 27.71
|
15.4 Giga cells per liter
Standard Deviation 31.84
|
13.1 Giga cells per liter
Standard Deviation 47.56
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Platelets,Week 32,n=19,15,10,12,13
|
-57.6 Giga cells per liter
Standard Deviation 66.52
|
-65.5 Giga cells per liter
Standard Deviation 51.20
|
-50.8 Giga cells per liter
Standard Deviation 33.70
|
-1.5 Giga cells per liter
Standard Deviation 45.26
|
10.7 Giga cells per liter
Standard Deviation 53.95
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Platelets,Week 36,n=15,12,10,12,12
|
-74.1 Giga cells per liter
Standard Deviation 32.84
|
-70.6 Giga cells per liter
Standard Deviation 58.49
|
-48.6 Giga cells per liter
Standard Deviation 23.64
|
13.4 Giga cells per liter
Standard Deviation 32.69
|
20.0 Giga cells per liter
Standard Deviation 85.28
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Platelets,Week 44,n=11,10,6,7,9
|
-69.5 Giga cells per liter
Standard Deviation 36.62
|
-76.7 Giga cells per liter
Standard Deviation 64.91
|
-58.2 Giga cells per liter
Standard Deviation 19.28
|
11.1 Giga cells per liter
Standard Deviation 48.18
|
-3.3 Giga cells per liter
Standard Deviation 56.78
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Platelets,Week 48,n=9,8,4,8,5
|
-68.3 Giga cells per liter
Standard Deviation 41.94
|
-71.4 Giga cells per liter
Standard Deviation 57.71
|
-80.8 Giga cells per liter
Standard Deviation 22.98
|
14.4 Giga cells per liter
Standard Deviation 53.59
|
0.4 Giga cells per liter
Standard Deviation 61.59
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Platelets,Week 52,n=8,5,5,5,4
|
-81.9 Giga cells per liter
Standard Deviation 38.36
|
-51.6 Giga cells per liter
Standard Deviation 43.90
|
-58.6 Giga cells per liter
Standard Deviation 40.79
|
-18.6 Giga cells per liter
Standard Deviation 55.44
|
-17.5 Giga cells per liter
Standard Deviation 38.04
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Eosinophils,Week 20,n=25,22,18,17,16
|
0.166 Giga cells per liter
Standard Deviation 0.2073
|
0.114 Giga cells per liter
Standard Deviation 0.2085
|
0.136 Giga cells per liter
Standard Deviation 0.1518
|
0.094 Giga cells per liter
Standard Deviation 0.1743
|
0.057 Giga cells per liter
Standard Deviation 0.0637
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Eosinophils,Week 28,n=18,18,11,14,13
|
0.163 Giga cells per liter
Standard Deviation 0.2562
|
0.068 Giga cells per liter
Standard Deviation 0.1340
|
0.120 Giga cells per liter
Standard Deviation 0.1340
|
0.046 Giga cells per liter
Standard Deviation 0.0714
|
0.051 Giga cells per liter
Standard Deviation 0.0538
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Eosinophils,Week 36,n=15,12,10,12,12
|
0.282 Giga cells per liter
Standard Deviation 0.3117
|
0.076 Giga cells per liter
Standard Deviation 0.1753
|
0.153 Giga cells per liter
Standard Deviation 0.1166
|
0.049 Giga cells per liter
Standard Deviation 0.0720
|
0.059 Giga cells per liter
Standard Deviation 0.0585
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Eosinophils,Week 52,n=8,5,5,5,4
|
0.151 Giga cells per liter
Standard Deviation 0.1865
|
0.192 Giga cells per liter
Standard Deviation 0.1839
|
0.172 Giga cells per liter
Standard Deviation 0.1207
|
0.108 Giga cells per liter
Standard Deviation 0.1139
|
0.013 Giga cells per liter
Standard Deviation 0.0802
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Leukocytes,Week 8,n=34,29,23,22,21
|
-4.04 Giga cells per liter
Standard Deviation 2.481
|
-5.65 Giga cells per liter
Standard Deviation 3.672
|
-4.42 Giga cells per liter
Standard Deviation 2.469
|
-1.79 Giga cells per liter
Standard Deviation 2.682
|
-0.26 Giga cells per liter
Standard Deviation 1.880
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Leukocytes,Week 12,n=31,28,23,22,22
|
-4.68 Giga cells per liter
Standard Deviation 2.666
|
-5.67 Giga cells per liter
Standard Deviation 2.551
|
-5.23 Giga cells per liter
Standard Deviation 2.581
|
-2.66 Giga cells per liter
Standard Deviation 2.883
|
-1.28 Giga cells per liter
Standard Deviation 1.810
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Leukocytes,Week 16,n=27,26,20,19,19
|
-5.21 Giga cells per liter
Standard Deviation 2.244
|
-5.61 Giga cells per liter
Standard Deviation 3.502
|
-5.36 Giga cells per liter
Standard Deviation 2.309
|
-2.98 Giga cells per liter
Standard Deviation 3.018
|
-0.79 Giga cells per liter
Standard Deviation 3.018
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Leukocytes,Week 24,n=22,21,16,16,16
|
-5.14 Giga cells per liter
Standard Deviation 3.559
|
-6.39 Giga cells per liter
Standard Deviation 2.952
|
-5.01 Giga cells per liter
Standard Deviation 1.884
|
-2.89 Giga cells per liter
Standard Deviation 3.892
|
-1.52 Giga cells per liter
Standard Deviation 2.738
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Leukocytes,Week 28,n=18,18,12,14,13
|
-5.46 Giga cells per liter
Standard Deviation 2.619
|
-6.04 Giga cells per liter
Standard Deviation 3.274
|
-4.58 Giga cells per liter
Standard Deviation 2.143
|
-3.01 Giga cells per liter
Standard Deviation 3.368
|
-1.97 Giga cells per liter
Standard Deviation 3.461
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Leukocytes,Week 32,n=19,15,10,12,13
|
-5.71 Giga cells per liter
Standard Deviation 2.419
|
-5.61 Giga cells per liter
Standard Deviation 3.250
|
-5.27 Giga cells per liter
Standard Deviation 1.696
|
-3.43 Giga cells per liter
Standard Deviation 3.342
|
-2.33 Giga cells per liter
Standard Deviation 3.011
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Leukocytes,Week 36,n=15,12,10,12,12
|
-5.76 Giga cells per liter
Standard Deviation 2.106
|
-6.82 Giga cells per liter
Standard Deviation 2.814
|
-5.58 Giga cells per liter
Standard Deviation 1.757
|
-3.36 Giga cells per liter
Standard Deviation 3.612
|
-2.95 Giga cells per liter
Standard Deviation 3.635
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Leukocytes,Week 44,n=11,10,6,7,9
|
-6.25 Giga cells per liter
Standard Deviation 2.300
|
-6.95 Giga cells per liter
Standard Deviation 2.441
|
-6.17 Giga cells per liter
Standard Deviation 1.726
|
-2.83 Giga cells per liter
Standard Deviation 3.875
|
-3.08 Giga cells per liter
Standard Deviation 3.056
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Leukocytes,Week 48,n=9,8,4,8,5
|
-6.88 Giga cells per liter
Standard Deviation 2.436
|
-7.35 Giga cells per liter
Standard Deviation 2.853
|
-6.48 Giga cells per liter
Standard Deviation 2.887
|
-2.69 Giga cells per liter
Standard Deviation 2.979
|
-3.00 Giga cells per liter
Standard Deviation 3.045
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Leukocytes,Week 52,n=8,5,5,5,4
|
-6.66 Giga cells per liter
Standard Deviation 2.654
|
-7.36 Giga cells per liter
Standard Deviation 2.920
|
-6.38 Giga cells per liter
Standard Deviation 2.262
|
-3.84 Giga cells per liter
Standard Deviation 3.467
|
-3.10 Giga cells per liter
Standard Deviation 4.090
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Lymphocytes,Week 2,n=37,36,24,23,25
|
0.015 Giga cells per liter
Standard Deviation 1.1645
|
0.002 Giga cells per liter
Standard Deviation 1.2620
|
-0.041 Giga cells per liter
Standard Deviation 1.3241
|
-0.159 Giga cells per liter
Standard Deviation 0.9064
|
-0.209 Giga cells per liter
Standard Deviation 0.9381
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Lymphocytes,Week 12,n=31,28,23,22,22
|
-0.215 Giga cells per liter
Standard Deviation 1.3052
|
-0.437 Giga cells per liter
Standard Deviation 1.2479
|
-0.081 Giga cells per liter
Standard Deviation 1.2018
|
-0.128 Giga cells per liter
Standard Deviation 1.0505
|
-0.344 Giga cells per liter
Standard Deviation 0.7846
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Lymphocytes,Week 16,n=27,26,20,19,19
|
-0.450 Giga cells per liter
Standard Deviation 1.3450
|
-0.704 Giga cells per liter
Standard Deviation 1.2994
|
-0.153 Giga cells per liter
Standard Deviation 0.7804
|
-0.327 Giga cells per liter
Standard Deviation 1.4269
|
-0.635 Giga cells per liter
Standard Deviation 0.8037
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Lymphocytes,Week 20,n=25,22,18,17,16
|
-0.616 Giga cells per liter
Standard Deviation 1.2793
|
-0.313 Giga cells per liter
Standard Deviation 1.3011
|
-0.439 Giga cells per liter
Standard Deviation 1.4363
|
-0.385 Giga cells per liter
Standard Deviation 0.8819
|
-0.533 Giga cells per liter
Standard Deviation 0.7432
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Lymphocytes,Week 24,n=22,21,16,16,16
|
-0.399 Giga cells per liter
Standard Deviation 1.4276
|
-0.179 Giga cells per liter
Standard Deviation 1.8386
|
-0.073 Giga cells per liter
Standard Deviation 0.7890
|
-0.401 Giga cells per liter
Standard Deviation 1.2030
|
-0.386 Giga cells per liter
Standard Deviation 0.7504
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Lymphocytes,Week 32,n=19,15,10,12,13
|
-0.602 Giga cells per liter
Standard Deviation 1.3438
|
-0.407 Giga cells per liter
Standard Deviation 1.4002
|
-0.476 Giga cells per liter
Standard Deviation 0.7997
|
-0.402 Giga cells per liter
Standard Deviation 1.2625
|
-0.492 Giga cells per liter
Standard Deviation 0.7877
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Lymphocytes,Week 36,n=15,12,10,12,12
|
-0.625 Giga cells per liter
Standard Deviation 1.5738
|
-0.672 Giga cells per liter
Standard Deviation 1.2263
|
-0.430 Giga cells per liter
Standard Deviation 0.7690
|
-0.417 Giga cells per liter
Standard Deviation 1.0538
|
-0.078 Giga cells per liter
Standard Deviation 0.7182
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Lymphocytes,Week 40,n=14,11,8,10,10
|
-0.929 Giga cells per liter
Standard Deviation 1.5351
|
-0.845 Giga cells per liter
Standard Deviation 1.3603
|
-0.570 Giga cells per liter
Standard Deviation 0.8261
|
-0.519 Giga cells per liter
Standard Deviation 1.1491
|
-0.681 Giga cells per liter
Standard Deviation 0.7363
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Lymphocytes,Week 44,n=11,10,6,7,9
|
-0.915 Giga cells per liter
Standard Deviation 1.2235
|
-1.047 Giga cells per liter
Standard Deviation 1.3375
|
-0.198 Giga cells per liter
Standard Deviation 0.9783
|
-1.029 Giga cells per liter
Standard Deviation 1.0293
|
-0.343 Giga cells per liter
Standard Deviation 0.8113
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Lymphocytes,Week 52,n=8,5,5,5,4
|
-1.253 Giga cells per liter
Standard Deviation 1.2857
|
-0.754 Giga cells per liter
Standard Deviation 1.0291
|
-0.286 Giga cells per liter
Standard Deviation 1.0455
|
0.194 Giga cells per liter
Standard Deviation 0.8800
|
-0.128 Giga cells per liter
Standard Deviation 1.2618
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Neutrophils,Week 2,n=37,36,24,23,25
|
-3.208 Giga cells per liter
Standard Deviation 2.5761
|
-3.454 Giga cells per liter
Standard Deviation 2.2265
|
-3.367 Giga cells per liter
Standard Deviation 2.5781
|
-0.748 Giga cells per liter
Standard Deviation 2.2688
|
0.387 Giga cells per liter
Standard Deviation 2.6156
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Neutrophils,Week 4,n=36,37,24,22,26
|
-3.791 Giga cells per liter
Standard Deviation 2.5242
|
-4.476 Giga cells per liter
Standard Deviation 2.3632
|
-4.106 Giga cells per liter
Standard Deviation 2.4354
|
-1.673 Giga cells per liter
Standard Deviation 1.9745
|
0.089 Giga cells per liter
Standard Deviation 3.1611
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Neutrophils,Week 8,n=34,29,22,22,21
|
-3.949 Giga cells per liter
Standard Deviation 2.5477
|
-5.271 Giga cells per liter
Standard Deviation 3.2214
|
-4.354 Giga cells per liter
Standard Deviation 2.4128
|
-1.869 Giga cells per liter
Standard Deviation 3.2525
|
0.192 Giga cells per liter
Standard Deviation 2.2180
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Neutrophils,Week 12,n=31,28,23,22,22
|
-4.590 Giga cells per liter
Standard Deviation 2.6603
|
-5.340 Giga cells per liter
Standard Deviation 2.6437
|
-5.250 Giga cells per liter
Standard Deviation 2.1872
|
-2.678 Giga cells per liter
Standard Deviation 3.1106
|
-1.019 Giga cells per liter
Standard Deviation 2.1306
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Neutrophils,Week 36,n=15,12,10,12,12
|
-5.444 Giga cells per liter
Standard Deviation 2.1894
|
-6.079 Giga cells per liter
Standard Deviation 3.0406
|
-5.265 Giga cells per liter
Standard Deviation 1.8375
|
-3.023 Giga cells per liter
Standard Deviation 3.9443
|
-3.018 Giga cells per liter
Standard Deviation 4.1223
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Neutrophils,Week 40,n=14,11,8,10,10
|
-5.416 Giga cells per liter
Standard Deviation 2.4371
|
-6.179 Giga cells per liter
Standard Deviation 2.8859
|
-5.916 Giga cells per liter
Standard Deviation 1.7172
|
-2.705 Giga cells per liter
Standard Deviation 3.4469
|
-1.663 Giga cells per liter
Standard Deviation 3.4090
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Platelets,Week 4,n=36,37,24,22,26
|
-45.9 Giga cells per liter
Standard Deviation 41.70
|
-64.3 Giga cells per liter
Standard Deviation 56.21
|
-49.0 Giga cells per liter
Standard Deviation 35.74
|
2.1 Giga cells per liter
Standard Deviation 41.23
|
-5.7 Giga cells per liter
Standard Deviation 43.51
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Platelets,Week 20,n=25,22,18,17,16
|
-52.2 Giga cells per liter
Standard Deviation 54.64
|
-69.5 Giga cells per liter
Standard Deviation 58.27
|
-53.5 Giga cells per liter
Standard Deviation 38.00
|
14.8 Giga cells per liter
Standard Deviation 44.55
|
-0.1 Giga cells per liter
Standard Deviation 56.21
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Platelets,Week 24,n=22,21,16,16,16
|
-58.0 Giga cells per liter
Standard Deviation 39.58
|
-72.4 Giga cells per liter
Standard Deviation 64.56
|
-57.5 Giga cells per liter
Standard Deviation 44.46
|
6.3 Giga cells per liter
Standard Deviation 46.94
|
20.1 Giga cells per liter
Standard Deviation 45.30
|
|
Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets
Platelets,Week 40,n=14,11,8,10,10
|
-77.4 Giga cells per liter
Standard Deviation 41.72
|
-66.9 Giga cells per liter
Standard Deviation 62.21
|
-42.0 Giga cells per liter
Standard Deviation 21.33
|
5.6 Giga cells per liter
Standard Deviation 45.38
|
5.3 Giga cells per liter
Standard Deviation 54.71
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)
Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
Hemoglobin,Week 52,n=8,5,5,5,4
|
2.9 Grams per liter
Standard Deviation 5.33
|
8.6 Grams per liter
Standard Deviation 12.84
|
10.4 Grams per liter
Standard Deviation 13.28
|
4.4 Grams per liter
Standard Deviation 6.47
|
2.8 Grams per liter
Standard Deviation 13.57
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
MCHC,Week 36,n=10,10,8,10,10
|
6.9 Grams per liter
Standard Deviation 5.11
|
6.7 Grams per liter
Standard Deviation 9.72
|
13.5 Grams per liter
Standard Deviation 8.07
|
7.9 Grams per liter
Standard Deviation 11.44
|
4.2 Grams per liter
Standard Deviation 5.90
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
MCHC,Week 2,n=32,33,18,22,23
|
-0.5 Grams per liter
Standard Deviation 6.21
|
0.1 Grams per liter
Standard Deviation 9.47
|
1.9 Grams per liter
Standard Deviation 5.11
|
-1.1 Grams per liter
Standard Deviation 6.56
|
1.2 Grams per liter
Standard Deviation 8.41
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
MCHC,Week 8,n=28,24,18,20,20
|
6.1 Grams per liter
Standard Deviation 8.97
|
6.7 Grams per liter
Standard Deviation 10.98
|
6.4 Grams per liter
Standard Deviation 9.09
|
0.6 Grams per liter
Standard Deviation 9.53
|
6.7 Grams per liter
Standard Deviation 8.19
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
MCHC,Week 12,n=25,23,18,20,20
|
6.5 Grams per liter
Standard Deviation 9.77
|
6.7 Grams per liter
Standard Deviation 9.03
|
5.9 Grams per liter
Standard Deviation 14.20
|
1.3 Grams per liter
Standard Deviation 9.55
|
4.9 Grams per liter
Standard Deviation 7.81
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
MCHC,Week 20,n=19,18,14,16,14
|
7.7 Grams per liter
Standard Deviation 8.43
|
10.8 Grams per liter
Standard Deviation 9.53
|
9.0 Grams per liter
Standard Deviation 8.60
|
3.4 Grams per liter
Standard Deviation 10.38
|
4.6 Grams per liter
Standard Deviation 12.48
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
MCHC,Week 24,n=16,16,13,15,14
|
4.7 Grams per liter
Standard Deviation 7.50
|
14.6 Grams per liter
Standard Deviation 11.04
|
4.9 Grams per liter
Standard Deviation 9.97
|
3.0 Grams per liter
Standard Deviation 7.46
|
4.9 Grams per liter
Standard Deviation 11.49
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
MCHC,Week 44,n=8,8,4,5,8
|
12.5 Grams per liter
Standard Deviation 7.17
|
9.9 Grams per liter
Standard Deviation 9.86
|
13.5 Grams per liter
Standard Deviation 4.12
|
5.2 Grams per liter
Standard Deviation 4.60
|
12.1 Grams per liter
Standard Deviation 10.99
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
MCHC,Week 48,n=6,7,2,6,4
|
13.3 Grams per liter
Standard Deviation 9.07
|
11.9 Grams per liter
Standard Deviation 9.84
|
10.5 Grams per liter
Standard Deviation 13.44
|
3.8 Grams per liter
Standard Deviation 11.48
|
9.3 Grams per liter
Standard Deviation 9.32
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
MCHC,Week 52,n=6,4,3,4,3
|
16.5 Grams per liter
Standard Deviation 5.47
|
18.8 Grams per liter
Standard Deviation 5.68
|
24.0 Grams per liter
Standard Deviation 3.46
|
11.3 Grams per liter
Standard Deviation 5.06
|
5.0 Grams per liter
Standard Deviation 9.85
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
Hemoglobin,Week 2,n=38,39,24,24,25
|
1.2 Grams per liter
Standard Deviation 6.50
|
2.5 Grams per liter
Standard Deviation 6.85
|
1.3 Grams per liter
Standard Deviation 8.72
|
-2.4 Grams per liter
Standard Deviation 7.08
|
-0.9 Grams per liter
Standard Deviation 5.44
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
Hemoglobin,Week 4,n=36,37,24,22,27
|
3.0 Grams per liter
Standard Deviation 6.37
|
2.8 Grams per liter
Standard Deviation 8.17
|
2.5 Grams per liter
Standard Deviation 6.55
|
-1.0 Grams per liter
Standard Deviation 8.45
|
-2.1 Grams per liter
Standard Deviation 6.86
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
Hemoglobin,Week 8,n=34,29,23,22,21
|
5.9 Grams per liter
Standard Deviation 9.57
|
4.7 Grams per liter
Standard Deviation 9.59
|
3.1 Grams per liter
Standard Deviation 7.00
|
-1.4 Grams per liter
Standard Deviation 10.54
|
-2.8 Grams per liter
Standard Deviation 7.41
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
Hemoglobin,Week 16,n=27,26,21,19,19
|
2.6 Grams per liter
Standard Deviation 6.00
|
5.8 Grams per liter
Standard Deviation 8.87
|
4.2 Grams per liter
Standard Deviation 7.03
|
-3.8 Grams per liter
Standard Deviation 10.55
|
-1.7 Grams per liter
Standard Deviation 7.47
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
Hemoglobin,Week 24,n=22,21,16,16,16
|
2.2 Grams per liter
Standard Deviation 8.67
|
7.0 Grams per liter
Standard Deviation 9.99
|
5.4 Grams per liter
Standard Deviation 6.38
|
-3.1 Grams per liter
Standard Deviation 12.05
|
-0.9 Grams per liter
Standard Deviation 6.43
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
Hemoglobin,Week 28,n=18,18,12,14,13
|
0.3 Grams per liter
Standard Deviation 9.68
|
5.8 Grams per liter
Standard Deviation 11.83
|
2.8 Grams per liter
Standard Deviation 6.92
|
-4.4 Grams per liter
Standard Deviation 11.45
|
-1.5 Grams per liter
Standard Deviation 8.88
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
Hemoglobin,Week 32,n=19,15,10,12,13
|
0.9 Grams per liter
Standard Deviation 9.04
|
5.1 Grams per liter
Standard Deviation 10.88
|
2.0 Grams per liter
Standard Deviation 9.42
|
-3.0 Grams per liter
Standard Deviation 10.05
|
0.8 Grams per liter
Standard Deviation 9.64
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
Hemoglobin,Week 36,n=15,12,10,12,12
|
4.4 Grams per liter
Standard Deviation 7.97
|
4.8 Grams per liter
Standard Deviation 11.91
|
4.0 Grams per liter
Standard Deviation 7.26
|
-2.6 Grams per liter
Standard Deviation 10.93
|
1.3 Grams per liter
Standard Deviation 9.68
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
Hemoglobin,Week 40,n=14,11,8,10,10
|
1.3 Grams per liter
Standard Deviation 8.03
|
3.8 Grams per liter
Standard Deviation 12.40
|
6.3 Grams per liter
Standard Deviation 5.47
|
-3.4 Grams per liter
Standard Deviation 11.24
|
-0.4 Grams per liter
Standard Deviation 7.86
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
Hemoglobin,Week 44,n=11,10,6,8,9
|
0.0 Grams per liter
Standard Deviation 8.00
|
6.7 Grams per liter
Standard Deviation 14.60
|
2.3 Grams per liter
Standard Deviation 7.84
|
-0.3 Grams per liter
Standard Deviation 11.70
|
2.8 Grams per liter
Standard Deviation 12.85
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
Hemoglobin,Week 48,n=9,8,4,8,5
|
2.4 Grams per liter
Standard Deviation 7.57
|
4.8 Grams per liter
Standard Deviation 12.62
|
2.8 Grams per liter
Standard Deviation 12.69
|
-4.6 Grams per liter
Standard Deviation 14.66
|
7.6 Grams per liter
Standard Deviation 15.57
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
MCHC,Week 4,n=31,31,19,20,25
|
1.6 Grams per liter
Standard Deviation 7.36
|
2.3 Grams per liter
Standard Deviation 11.94
|
2.6 Grams per liter
Standard Deviation 9.46
|
0.1 Grams per liter
Standard Deviation 5.17
|
2.4 Grams per liter
Standard Deviation 9.32
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
MCHC,Week 16,n=22,21,17,17,17
|
8.3 Grams per liter
Standard Deviation 9.80
|
8.9 Grams per liter
Standard Deviation 12.41
|
10.2 Grams per liter
Standard Deviation 8.50
|
0.9 Grams per liter
Standard Deviation 11.52
|
4.5 Grams per liter
Standard Deviation 9.62
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
MCHC,Week 28,n=13,14,10,12,11
|
4.5 Grams per liter
Standard Deviation 7.78
|
9.2 Grams per liter
Standard Deviation 11.52
|
8.9 Grams per liter
Standard Deviation 11.41
|
2.8 Grams per liter
Standard Deviation 13.57
|
-0.4 Grams per liter
Standard Deviation 7.86
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
MCHC,Week 32,n=13,11,8,10,11
|
6.9 Grams per liter
Standard Deviation 9.33
|
8.4 Grams per liter
Standard Deviation 10.45
|
8.8 Grams per liter
Standard Deviation 9.05
|
6.7 Grams per liter
Standard Deviation 8.88
|
1.4 Grams per liter
Standard Deviation 8.58
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
MCHC,Week 40,n=10,9,7,8,9
|
11.5 Grams per liter
Standard Deviation 9.89
|
11.3 Grams per liter
Standard Deviation 7.75
|
14.4 Grams per liter
Standard Deviation 12.45
|
5.1 Grams per liter
Standard Deviation 15.30
|
13.9 Grams per liter
Standard Deviation 12.39
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
Hemoglobin,Week 12,n=31,28,23,22,22
|
5.8 Grams per liter
Standard Deviation 7.85
|
8.4 Grams per liter
Standard Deviation 10.62
|
4.7 Grams per liter
Standard Deviation 6.24
|
-3.2 Grams per liter
Standard Deviation 11.11
|
-1.4 Grams per liter
Standard Deviation 7.10
|
|
Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin
Hemoglobin,Week 20,n=25,23,18,18,16
|
2.0 Grams per liter
Standard Deviation 7.89
|
7.4 Grams per liter
Standard Deviation 9.69
|
3.3 Grams per liter
Standard Deviation 5.58
|
-4.6 Grams per liter
Standard Deviation 11.32
|
-0.6 Grams per liter
Standard Deviation 6.22
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Change From Baseline in Hematology Parameter-Hematocrit
Week 2,n=38,39,24,24,25
|
0.0040 Proportion of red blood cells in blood
Standard Deviation 0.01988
|
0.0060 Proportion of red blood cells in blood
Standard Deviation 0.02186
|
0.0008 Proportion of red blood cells in blood
Standard Deviation 0.02909
|
-0.0063 Proportion of red blood cells in blood
Standard Deviation 0.02491
|
-0.0030 Proportion of red blood cells in blood
Standard Deviation 0.01813
|
|
Part A: Change From Baseline in Hematology Parameter-Hematocrit
Week 4,n=36,37,24,22,27
|
0.0059 Proportion of red blood cells in blood
Standard Deviation 0.01903
|
0.0048 Proportion of red blood cells in blood
Standard Deviation 0.02635
|
0.0040 Proportion of red blood cells in blood
Standard Deviation 0.01531
|
-0.0035 Proportion of red blood cells in blood
Standard Deviation 0.02676
|
-0.0087 Proportion of red blood cells in blood
Standard Deviation 0.02004
|
|
Part A: Change From Baseline in Hematology Parameter-Hematocrit
Week 8,n=34,29,23,22,21
|
0.0101 Proportion of red blood cells in blood
Standard Deviation 0.02601
|
0.0054 Proportion of red blood cells in blood
Standard Deviation 0.03213
|
0.0019 Proportion of red blood cells in blood
Standard Deviation 0.02110
|
-0.0054 Proportion of red blood cells in blood
Standard Deviation 0.03286
|
-0.0159 Proportion of red blood cells in blood
Standard Deviation 0.01918
|
|
Part A: Change From Baseline in Hematology Parameter-Hematocrit
Week 12,n=31,28,23,22,22
|
0.0087 Proportion of red blood cells in blood
Standard Deviation 0.02386
|
0.0148 Proportion of red blood cells in blood
Standard Deviation 0.03272
|
0.0059 Proportion of red blood cells in blood
Standard Deviation 0.01970
|
-0.0118 Proportion of red blood cells in blood
Standard Deviation 0.03281
|
-0.0095 Proportion of red blood cells in blood
Standard Deviation 0.02108
|
|
Part A: Change From Baseline in Hematology Parameter-Hematocrit
Week 16,n=27,26,21,19,19
|
-0.0037 Proportion of red blood cells in blood
Standard Deviation 0.02187
|
0.0049 Proportion of red blood cells in blood
Standard Deviation 0.02833
|
0.0008 Proportion of red blood cells in blood
Standard Deviation 0.01961
|
-0.0135 Proportion of red blood cells in blood
Standard Deviation 0.02976
|
-0.0095 Proportion of red blood cells in blood
Standard Deviation 0.02347
|
|
Part A: Change From Baseline in Hematology Parameter-Hematocrit
Week 20,n=25,23,18,18,16
|
-0.0063 Proportion of red blood cells in blood
Standard Deviation 0.02436
|
0.0066 Proportion of red blood cells in blood
Standard Deviation 0.03019
|
-0.0015 Proportion of red blood cells in blood
Standard Deviation 0.01398
|
-0.0184 Proportion of red blood cells in blood
Standard Deviation 0.02972
|
-0.0062 Proportion of red blood cells in blood
Standard Deviation 0.02076
|
|
Part A: Change From Baseline in Hematology Parameter-Hematocrit
Week 24,n=22,21,16,16,16
|
-0.0017 Proportion of red blood cells in blood
Standard Deviation 0.02882
|
0.0010 Proportion of red blood cells in blood
Standard Deviation 0.02839
|
0.0089 Proportion of red blood cells in blood
Standard Deviation 0.01973
|
-0.0133 Proportion of red blood cells in blood
Standard Deviation 0.03478
|
-0.0077 Proportion of red blood cells in blood
Standard Deviation 0.01599
|
|
Part A: Change From Baseline in Hematology Parameter-Hematocrit
Week 28,n=18,18,12,14,13
|
-0.0089 Proportion of red blood cells in blood
Standard Deviation 0.02917
|
0.0039 Proportion of red blood cells in blood
Standard Deviation 0.03455
|
-0.0046 Proportion of red blood cells in blood
Standard Deviation 0.01858
|
-0.0186 Proportion of red blood cells in blood
Standard Deviation 0.02814
|
-0.0035 Proportion of red blood cells in blood
Standard Deviation 0.02785
|
|
Part A: Change From Baseline in Hematology Parameter-Hematocrit
Week 32,n=19,15,10,12,13
|
-0.0076 Proportion of red blood cells in blood
Standard Deviation 0.02782
|
0.0027 Proportion of red blood cells in blood
Standard Deviation 0.02994
|
-0.0060 Proportion of red blood cells in blood
Standard Deviation 0.03161
|
-0.0176 Proportion of red blood cells in blood
Standard Deviation 0.02473
|
0.0025 Proportion of red blood cells in blood
Standard Deviation 0.02741
|
|
Part A: Change From Baseline in Hematology Parameter-Hematocrit
Week 36,n=15,12,10,12,12
|
0.0012 Proportion of red blood cells in blood
Standard Deviation 0.02603
|
0.0036 Proportion of red blood cells in blood
Standard Deviation 0.03232
|
-0.0054 Proportion of red blood cells in blood
Standard Deviation 0.01811
|
-0.0198 Proportion of red blood cells in blood
Standard Deviation 0.02570
|
0.0018 Proportion of red blood cells in blood
Standard Deviation 0.03090
|
|
Part A: Change From Baseline in Hematology Parameter-Hematocrit
Week 40,n=14,11,8,10,10
|
-0.0115 Proportion of red blood cells in blood
Standard Deviation 0.03075
|
-0.0052 Proportion of red blood cells in blood
Standard Deviation 0.03398
|
-0.0009 Proportion of red blood cells in blood
Standard Deviation 0.01086
|
-0.0193 Proportion of red blood cells in blood
Standard Deviation 0.02157
|
-0.0160 Proportion of red blood cells in blood
Standard Deviation 0.02099
|
|
Part A: Change From Baseline in Hematology Parameter-Hematocrit
Week 44,n=11,10,6,7,9
|
-0.0185 Proportion of red blood cells in blood
Standard Deviation 0.03039
|
0.0054 Proportion of red blood cells in blood
Standard Deviation 0.03463
|
-0.0097 Proportion of red blood cells in blood
Standard Deviation 0.02548
|
-0.0126 Proportion of red blood cells in blood
Standard Deviation 0.03225
|
-0.0037 Proportion of red blood cells in blood
Standard Deviation 0.03048
|
|
Part A: Change From Baseline in Hematology Parameter-Hematocrit
Week 48,n=9,8,4,8,5
|
-0.0136 Proportion of red blood cells in blood
Standard Deviation 0.02709
|
-0.0025 Proportion of red blood cells in blood
Standard Deviation 0.03217
|
-0.0053 Proportion of red blood cells in blood
Standard Deviation 0.04366
|
-0.0216 Proportion of red blood cells in blood
Standard Deviation 0.03428
|
0.0144 Proportion of red blood cells in blood
Standard Deviation 0.04123
|
|
Part A: Change From Baseline in Hematology Parameter-Hematocrit
Week 52,n=8,5,5,5,4
|
-0.0135 Proportion of red blood cells in blood
Standard Deviation 0.02112
|
0.0016 Proportion of red blood cells in blood
Standard Deviation 0.04082
|
0.0058 Proportion of red blood cells in blood
Standard Deviation 0.04370
|
-0.0006 Proportion of red blood cells in blood
Standard Deviation 0.01558
|
0.0025 Proportion of red blood cells in blood
Standard Deviation 0.03288
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume
Week 2,n=38,39,24,24,25
|
0.5 Femtoliter
Standard Deviation 1.35
|
0.5 Femtoliter
Standard Deviation 1.64
|
0.5 Femtoliter
Standard Deviation 1.38
|
0.6 Femtoliter
Standard Deviation 1.38
|
0.4 Femtoliter
Standard Deviation 1.44
|
|
Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume
Week 4,n=36,37,24,22,27
|
0.9 Femtoliter
Standard Deviation 1.95
|
1.1 Femtoliter
Standard Deviation 2.15
|
1.0 Femtoliter
Standard Deviation 1.69
|
0.6 Femtoliter
Standard Deviation 1.68
|
0.6 Femtoliter
Standard Deviation 2.28
|
|
Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume
Week 8,n=34,29,23,22,21
|
1.2 Femtoliter
Standard Deviation 2.54
|
1.8 Femtoliter
Standard Deviation 3.27
|
1.9 Femtoliter
Standard Deviation 2.72
|
1.7 Femtoliter
Standard Deviation 2.34
|
-0.2 Femtoliter
Standard Deviation 2.91
|
|
Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume
Week 12,n=31,28,23,22,22
|
0.8 Femtoliter
Standard Deviation 3.41
|
2.0 Femtoliter
Standard Deviation 4.29
|
2.6 Femtoliter
Standard Deviation 3.14
|
0.9 Femtoliter
Standard Deviation 3.16
|
0.3 Femtoliter
Standard Deviation 4.07
|
|
Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume
Week 24,n=22,21,16,16,16
|
1.1 Femtoliter
Standard Deviation 4.20
|
1.1 Femtoliter
Standard Deviation 3.91
|
2.6 Femtoliter
Standard Deviation 3.36
|
-1.0 Femtoliter
Standard Deviation 4.44
|
-1.6 Femtoliter
Standard Deviation 4.84
|
|
Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume
Week 32,n=19,15,10,12,13
|
0.9 Femtoliter
Standard Deviation 4.42
|
2.0 Femtoliter
Standard Deviation 4.44
|
1.3 Femtoliter
Standard Deviation 3.13
|
0.3 Femtoliter
Standard Deviation 4.89
|
-0.5 Femtoliter
Standard Deviation 3.64
|
|
Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume
Week 40,n=14,11,8,10,10
|
0.6 Femtoliter
Standard Deviation 3.73
|
1.8 Femtoliter
Standard Deviation 5.25
|
2.0 Femtoliter
Standard Deviation 2.83
|
0.4 Femtoliter
Standard Deviation 4.95
|
-2.1 Femtoliter
Standard Deviation 3.00
|
|
Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume
Week 44,n=11,10,6,8,9
|
-0.5 Femtoliter
Standard Deviation 3.50
|
2.5 Femtoliter
Standard Deviation 5.08
|
1.7 Femtoliter
Standard Deviation 3.50
|
-0.7 Femtoliter
Standard Deviation 6.87
|
-0.7 Femtoliter
Standard Deviation 2.83
|
|
Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume
Week 48,n=9,8,4,8,5
|
-0.4 Femtoliter
Standard Deviation 3.50
|
3.3 Femtoliter
Standard Deviation 4.95
|
2.3 Femtoliter
Standard Deviation 4.50
|
-1.1 Femtoliter
Standard Deviation 6.92
|
2.0 Femtoliter
Standard Deviation 2.12
|
|
Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume
Week 52,n=8,5,5,5,4
|
-0.6 Femtoliter
Standard Deviation 3.02
|
3.2 Femtoliter
Standard Deviation 5.12
|
1.4 Femtoliter
Standard Deviation 4.16
|
3.2 Femtoliter
Standard Deviation 5.72
|
1.0 Femtoliter
Standard Deviation 2.58
|
|
Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume
Week 16,n=27,26,21,19,19
|
1.0 Femtoliter
Standard Deviation 4.14
|
2.2 Femtoliter
Standard Deviation 4.36
|
3.1 Femtoliter
Standard Deviation 3.37
|
0.4 Femtoliter
Standard Deviation 4.03
|
-0.3 Femtoliter
Standard Deviation 4.98
|
|
Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume
Week 20,n=25,23,18,18,16
|
1.2 Femtoliter
Standard Deviation 4.42
|
1.8 Femtoliter
Standard Deviation 4.35
|
2.1 Femtoliter
Standard Deviation 3.12
|
-0.5 Femtoliter
Standard Deviation 4.72
|
0.1 Femtoliter
Standard Deviation 3.54
|
|
Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume
Week 28,n=18,18,12,14,13
|
0.6 Femtoliter
Standard Deviation 4.02
|
1.4 Femtoliter
Standard Deviation 4.19
|
2.0 Femtoliter
Standard Deviation 2.26
|
-0.4 Femtoliter
Standard Deviation 4.43
|
-0.5 Femtoliter
Standard Deviation 3.95
|
|
Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume
Week 36,n=15,12,10,12,12
|
1.8 Femtoliter
Standard Deviation 3.49
|
1.6 Femtoliter
Standard Deviation 4.76
|
0.9 Femtoliter
Standard Deviation 2.47
|
-0.5 Femtoliter
Standard Deviation 4.93
|
-0.2 Femtoliter
Standard Deviation 2.55
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin
Week 36,n=15,12,10,12,12
|
1.42 Picograms
Standard Deviation 0.944
|
1.29 Picograms
Standard Deviation 1.905
|
1.39 Picograms
Standard Deviation 1.005
|
0.68 Picograms
Standard Deviation 2.327
|
0.15 Picograms
Standard Deviation 0.971
|
|
Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin
Week 2,n=38,39,24,24,25
|
0.13 Picograms
Standard Deviation 0.571
|
0.29 Picograms
Standard Deviation 0.730
|
0.42 Picograms
Standard Deviation 0.512
|
0.12 Picograms
Standard Deviation 0.494
|
0.22 Picograms
Standard Deviation 0.678
|
|
Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin
Week 8,n=34,29,23,22,21
|
0.96 Picograms
Standard Deviation 1.041
|
1.20 Picograms
Standard Deviation 1.056
|
1.16 Picograms
Standard Deviation 1.178
|
0.60 Picograms
Standard Deviation 0.751
|
0.49 Picograms
Standard Deviation 1.022
|
|
Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin
Week 12,n=31,28,23,22,22
|
0.94 Picograms
Standard Deviation 1.341
|
1.43 Picograms
Standard Deviation 1.372
|
1.38 Picograms
Standard Deviation 1.630
|
0.44 Picograms
Standard Deviation 1.110
|
0.47 Picograms
Standard Deviation 1.480
|
|
Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin
Week 20,n=25,23,18,18,16
|
1.24 Picograms
Standard Deviation 1.529
|
1.69 Picograms
Standard Deviation 1.605
|
1.48 Picograms
Standard Deviation 1.256
|
0.14 Picograms
Standard Deviation 1.666
|
0.39 Picograms
Standard Deviation 1.696
|
|
Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin
Week 32,n=19,15,10,12,13
|
1.01 Picograms
Standard Deviation 1.498
|
1.57 Picograms
Standard Deviation 1.694
|
1.27 Picograms
Standard Deviation 1.111
|
0.68 Picograms
Standard Deviation 2.103
|
-0.14 Picograms
Standard Deviation 1.413
|
|
Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin
Week 40,n=14,11,8,10,10
|
1.30 Picograms
Standard Deviation 0.818
|
1.75 Picograms
Standard Deviation 1.914
|
1.91 Picograms
Standard Deviation 1.373
|
0.71 Picograms
Standard Deviation 2.617
|
0.44 Picograms
Standard Deviation 1.492
|
|
Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin
Week 44,n=11,10,6,8,9
|
1.16 Picograms
Standard Deviation 0.727
|
1.83 Picograms
Standard Deviation 2.214
|
1.63 Picograms
Standard Deviation 1.178
|
0.30 Picograms
Standard Deviation 2.460
|
0.77 Picograms
Standard Deviation 1.261
|
|
Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin
Week 52,n=8,5,5,5,4
|
1.44 Picograms
Standard Deviation 0.950
|
2.70 Picograms
Standard Deviation 1.744
|
2.24 Picograms
Standard Deviation 1.484
|
1.84 Picograms
Standard Deviation 1.889
|
0.80 Picograms
Standard Deviation 1.068
|
|
Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin
Week 4,n=36,37,24,22,27
|
0.53 Picograms
Standard Deviation 0.786
|
0.58 Picograms
Standard Deviation 0.877
|
0.55 Picograms
Standard Deviation 0.672
|
0.25 Picograms
Standard Deviation 0.458
|
0.36 Picograms
Standard Deviation 0.892
|
|
Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin
Week 16,n=27,26,21,19,19
|
1.16 Picograms
Standard Deviation 1.345
|
1.59 Picograms
Standard Deviation 1.617
|
1.83 Picograms
Standard Deviation 1.424
|
0.24 Picograms
Standard Deviation 1.508
|
0.22 Picograms
Standard Deviation 1.927
|
|
Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin
Week 24,n=22,21,16,16,16
|
0.97 Picograms
Standard Deviation 1.491
|
1.80 Picograms
Standard Deviation 1.663
|
1.34 Picograms
Standard Deviation 1.230
|
-0.04 Picograms
Standard Deviation 1.727
|
-0.08 Picograms
Standard Deviation 2.041
|
|
Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin
Week 28,n=18,18,12,14,13
|
0.91 Picograms
Standard Deviation 1.659
|
1.48 Picograms
Standard Deviation 1.618
|
1.47 Picograms
Standard Deviation 1.409
|
0.21 Picograms
Standard Deviation 2.000
|
-0.20 Picograms
Standard Deviation 1.493
|
|
Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin
Week 48,n=9,8,4,8,5
|
1.36 Picograms
Standard Deviation 0.633
|
2.25 Picograms
Standard Deviation 2.194
|
1.73 Picograms
Standard Deviation 1.389
|
0.14 Picograms
Standard Deviation 2.934
|
1.32 Picograms
Standard Deviation 1.119
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A:Change From Baseline in Hematology Parameter- Erythrocytes
Week 4,n=36,37,24,22,27
|
0.01 trillion cells per liter
Standard Deviation 0.208
|
-0.01 trillion cells per liter
Standard Deviation 0.311
|
-0.01 trillion cells per liter
Standard Deviation 0.202
|
-0.09 trillion cells per liter
Standard Deviation 0.268
|
-0.14 trillion cells per liter
Standard Deviation 0.248
|
|
Part A:Change From Baseline in Hematology Parameter- Erythrocytes
Week 16,n=27,26,21,19,19
|
-0.09 trillion cells per liter
Standard Deviation 0.238
|
-0.07 trillion cells per liter
Standard Deviation 0.312
|
-0.14 trillion cells per liter
Standard Deviation 0.282
|
-0.19 trillion cells per liter
Standard Deviation 0.399
|
-0.11 trillion cells per liter
Standard Deviation 0.303
|
|
Part A:Change From Baseline in Hematology Parameter- Erythrocytes
Week 36,n=15,12,10,12,12
|
-0.08 trillion cells per liter
Standard Deviation 0.262
|
-0.04 trillion cells per liter
Standard Deviation 0.378
|
-0.10 trillion cells per liter
Standard Deviation 0.183
|
-0.21 trillion cells per liter
Standard Deviation 0.358
|
0.03 trillion cells per liter
Standard Deviation 0.391
|
|
Part A:Change From Baseline in Hematology Parameter- Erythrocytes
Week 2,n=38,39,24,24,25
|
0.01 trillion cells per liter
Standard Deviation 0.232
|
0.02 trillion cells per liter
Standard Deviation 0.265
|
-0.01 trillion cells per liter
Standard Deviation 0.303
|
-0.10 trillion cells per liter
Standard Deviation 0.254
|
-0.07 trillion cells per liter
Standard Deviation 0.221
|
|
Part A:Change From Baseline in Hematology Parameter- Erythrocytes
Week 8,n=34,29,23,22,21
|
0.04 trillion cells per liter
Standard Deviation 0.249
|
-0.04 trillion cells per liter
Standard Deviation 0.406
|
-0.08 trillion cells per liter
Standard Deviation 0.300
|
-0.16 trillion cells per liter
Standard Deviation 0.372
|
-0.17 trillion cells per liter
Standard Deviation 0.219
|
|
Part A:Change From Baseline in Hematology Parameter- Erythrocytes
Week 12,n=31,28,23,22,22
|
0.03 trillion cells per liter
Standard Deviation 0.255
|
0.05 trillion cells per liter
Standard Deviation 0.417
|
-0.07 trillion cells per liter
Standard Deviation 0.265
|
-0.20 trillion cells per liter
Standard Deviation 0.379
|
-0.11 trillion cells per liter
Standard Deviation 0.237
|
|
Part A:Change From Baseline in Hematology Parameter- Erythrocytes
Week 20,n=25,23,18,18,16
|
-0.13 trillion cells per liter
Standard Deviation 0.263
|
-0.03 trillion cells per liter
Standard Deviation 0.305
|
-0.12 trillion cells per liter
Standard Deviation 0.183
|
-0.20 trillion cells per liter
Standard Deviation 0.461
|
-0.08 trillion cells per liter
Standard Deviation 0.286
|
|
Part A:Change From Baseline in Hematology Parameter- Erythrocytes
Week 24,n=22,21,16,16,16
|
-0.09 trillion cells per liter
Standard Deviation 0.270
|
-0.06 trillion cells per liter
Standard Deviation 0.282
|
-0.04 trillion cells per liter
Standard Deviation 0.234
|
-0.11 trillion cells per liter
Standard Deviation 0.464
|
-0.01 trillion cells per liter
Standard Deviation 0.289
|
|
Part A:Change From Baseline in Hematology Parameter- Erythrocytes
Week 28,n=18,18,12,14,13
|
-0.14 trillion cells per liter
Standard Deviation 0.295
|
-0.04 trillion cells per liter
Standard Deviation 0.327
|
-0.16 trillion cells per liter
Standard Deviation 0.231
|
-0.18 trillion cells per liter
Standard Deviation 0.377
|
-0.02 trillion cells per liter
Standard Deviation 0.387
|
|
Part A:Change From Baseline in Hematology Parameter- Erythrocytes
Week 32,n=19,15,10,12,13
|
-0.13 trillion cells per liter
Standard Deviation 0.292
|
-0.09 trillion cells per liter
Standard Deviation 0.259
|
-0.13 trillion cells per liter
Standard Deviation 0.330
|
-0.22 trillion cells per liter
Standard Deviation 0.321
|
0.04 trillion cells per liter
Standard Deviation 0.362
|
|
Part A:Change From Baseline in Hematology Parameter- Erythrocytes
Week 40,n=14,11,8,10,10
|
-0.16 trillion cells per liter
Standard Deviation 0.234
|
-0.16 trillion cells per liter
Standard Deviation 0.380
|
-0.09 trillion cells per liter
Standard Deviation 0.189
|
-0.22 trillion cells per liter
Standard Deviation 0.301
|
-0.10 trillion cells per liter
Standard Deviation 0.330
|
|
Part A:Change From Baseline in Hematology Parameter- Erythrocytes
Week 44,n=11,10,6,7,9
|
-0.18 trillion cells per liter
Standard Deviation 0.286
|
-0.10 trillion cells per liter
Standard Deviation 0.333
|
-0.17 trillion cells per liter
Standard Deviation 0.320
|
-0.10 trillion cells per liter
Standard Deviation 0.216
|
-0.03 trillion cells per liter
Standard Deviation 0.367
|
|
Part A:Change From Baseline in Hematology Parameter- Erythrocytes
Week 48,n=9,8,4,8,5
|
-0.14 trillion cells per liter
Standard Deviation 0.240
|
-0.23 trillion cells per liter
Standard Deviation 0.266
|
-0.18 trillion cells per liter
Standard Deviation 0.457
|
-0.20 trillion cells per liter
Standard Deviation 0.251
|
0.04 trillion cells per liter
Standard Deviation 0.434
|
|
Part A:Change From Baseline in Hematology Parameter- Erythrocytes
Week 52,n=8,5,5,5,4
|
-0.16 trillion cells per liter
Standard Deviation 0.283
|
-0.18 trillion cells per liter
Standard Deviation 0.370
|
-0.02 trillion cells per liter
Standard Deviation 0.531
|
-0.18 trillion cells per liter
Standard Deviation 0.192
|
-0.05 trillion cells per liter
Standard Deviation 0.332
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea . Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Phosphate,Week 44,n=11,11,6,8,9
|
0.142 Millimoles per liter
Standard Deviation 0.2117
|
0.025 Millimoles per liter
Standard Deviation 0.1874
|
0.090 Millimoles per liter
Standard Deviation 0.2131
|
-0.065 Millimoles per liter
Standard Deviation 0.2267
|
0.218 Millimoles per liter
Standard Deviation 0.2184
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Sodium,Week 16,n=28,26,22,19,18
|
1.0 Millimoles per liter
Standard Deviation 2.28
|
0.6 Millimoles per liter
Standard Deviation 3.09
|
-0.2 Millimoles per liter
Standard Deviation 2.25
|
-0.3 Millimoles per liter
Standard Deviation 1.37
|
2.3 Millimoles per liter
Standard Deviation 3.59
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Sodium,Week 2,n=38,39,26,24,26
|
0.3 Millimoles per liter
Standard Deviation 2.11
|
0.0 Millimoles per liter
Standard Deviation 2.33
|
-0.8 Millimoles per liter
Standard Deviation 2.37
|
-0.2 Millimoles per liter
Standard Deviation 1.52
|
0.9 Millimoles per liter
Standard Deviation 2.92
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Sodium,Week 4,n=37,38,25,23,27
|
0.7 Millimoles per liter
Standard Deviation 2.15
|
0.4 Millimoles per liter
Standard Deviation 2.11
|
0.2 Millimoles per liter
Standard Deviation 2.29
|
0.0 Millimoles per liter
Standard Deviation 1.43
|
0.6 Millimoles per liter
Standard Deviation 2.65
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Sodium,Week 8,n=34,31,24,22,23
|
1.1 Millimoles per liter
Standard Deviation 2.10
|
0.9 Millimoles per liter
Standard Deviation 3.12
|
0.1 Millimoles per liter
Standard Deviation 2.32
|
0.5 Millimoles per liter
Standard Deviation 1.50
|
1.7 Millimoles per liter
Standard Deviation 2.91
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Sodium,Week 28,n=19,18,12,13,14
|
0.9 Millimoles per liter
Standard Deviation 2.27
|
1.2 Millimoles per liter
Standard Deviation 2.75
|
0.5 Millimoles per liter
Standard Deviation 1.93
|
-0.8 Millimoles per liter
Standard Deviation 3.22
|
2.4 Millimoles per liter
Standard Deviation 3.54
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Sodium,Week 32,n=19,15,10,12,13
|
0.7 Millimoles per liter
Standard Deviation 2.31
|
-0.3 Millimoles per liter
Standard Deviation 2.63
|
-0.2 Millimoles per liter
Standard Deviation 2.04
|
-0.8 Millimoles per liter
Standard Deviation 3.16
|
3.2 Millimoles per liter
Standard Deviation 4.13
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Sodium,Week 36,n=15,12,10,12,13
|
0.5 Millimoles per liter
Standard Deviation 1.96
|
0.6 Millimoles per liter
Standard Deviation 2.43
|
-0.4 Millimoles per liter
Standard Deviation 2.07
|
-0.2 Millimoles per liter
Standard Deviation 1.85
|
2.8 Millimoles per liter
Standard Deviation 3.60
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
calcium,Week 16,n=28,26,22,19,18
|
0.009 Millimoles per liter
Standard Deviation 0.0974
|
0.050 Millimoles per liter
Standard Deviation 0.0808
|
0.018 Millimoles per liter
Standard Deviation 0.0954
|
-0.008 Millimoles per liter
Standard Deviation 0.0707
|
0.044 Millimoles per liter
Standard Deviation 0.0768
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
calcium,Week 28,n=19,18,12,13,14
|
0.006 Millimoles per liter
Standard Deviation 0.1102
|
0.066 Millimoles per liter
Standard Deviation 0.1106
|
0.054 Millimoles per liter
Standard Deviation 0.1232
|
0.018 Millimoles per liter
Standard Deviation 0.0838
|
0.076 Millimoles per liter
Standard Deviation 0.1108
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
calcium,Week 32,n=19,15,10,12,13
|
0.029 Millimoles per liter
Standard Deviation 0.1119
|
0.044 Millimoles per liter
Standard Deviation 0.0923
|
0.059 Millimoles per liter
Standard Deviation 0.0737
|
-0.008 Millimoles per liter
Standard Deviation 0.0978
|
0.075 Millimoles per liter
Standard Deviation 0.1271
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
calcium,Week 40,n=15,11,9,10,10
|
0.077 Millimoles per liter
Standard Deviation 0.1012
|
0.016 Millimoles per liter
Standard Deviation 0.0662
|
0.008 Millimoles per liter
Standard Deviation 0.0930
|
-0.042 Millimoles per liter
Standard Deviation 0.0561
|
0.037 Millimoles per liter
Standard Deviation 0.0589
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
calcium,Week 48,n=9,8,5,8,5
|
-0.007 Millimoles per liter
Standard Deviation 0.1126
|
0.028 Millimoles per liter
Standard Deviation 0.0956
|
-0.018 Millimoles per liter
Standard Deviation 0.0769
|
-0.035 Millimoles per liter
Standard Deviation 0.0769
|
0.142 Millimoles per liter
Standard Deviation 0.0782
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Carbon Dioxide,Week 32,n=19,15,10,12,13
|
-1.0 Millimoles per liter
Standard Deviation 3.65
|
0.8 Millimoles per liter
Standard Deviation 2.08
|
-1.4 Millimoles per liter
Standard Deviation 2.17
|
-0.6 Millimoles per liter
Standard Deviation 2.43
|
0.2 Millimoles per liter
Standard Deviation 2.24
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Chloride,Week 4,n=37,38,25,23,27
|
1.8 Millimoles per liter
Standard Deviation 2.34
|
1.6 Millimoles per liter
Standard Deviation 2.10
|
1.4 Millimoles per liter
Standard Deviation 1.87
|
0.7 Millimoles per liter
Standard Deviation 2.14
|
1.4 Millimoles per liter
Standard Deviation 2.79
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Chloride,Week 16,n=28,26,22,19,18
|
3.0 Millimoles per liter
Standard Deviation 2.27
|
2.3 Millimoles per liter
Standard Deviation 2.54
|
2.2 Millimoles per liter
Standard Deviation 2.46
|
1.1 Millimoles per liter
Standard Deviation 2.04
|
2.4 Millimoles per liter
Standard Deviation 3.40
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Glucose,Week 48,n=9,8,5,8,5
|
-1.39 Millimoles per liter
Standard Deviation 4.249
|
-0.93 Millimoles per liter
Standard Deviation 2.077
|
-0.62 Millimoles per liter
Standard Deviation 1.441
|
-0.88 Millimoles per liter
Standard Deviation 1.369
|
-0.36 Millimoles per liter
Standard Deviation 2.196
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Chloride,Week 36,n=15,12,10,12,13
|
3.8 Millimoles per liter
Standard Deviation 1.74
|
2.4 Millimoles per liter
Standard Deviation 2.78
|
1.9 Millimoles per liter
Standard Deviation 2.47
|
1.1 Millimoles per liter
Standard Deviation 1.88
|
2.8 Millimoles per liter
Standard Deviation 3.37
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Chloride,Week 40,n=15,11,9,10,10
|
3.3 Millimoles per liter
Standard Deviation 2.49
|
3.6 Millimoles per liter
Standard Deviation 1.12
|
1.4 Millimoles per liter
Standard Deviation 1.94
|
1.9 Millimoles per liter
Standard Deviation 1.45
|
3.9 Millimoles per liter
Standard Deviation 3.03
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Chloride,Week 48,n=9,8,5,8,5
|
4.6 Millimoles per liter
Standard Deviation 1.88
|
2.1 Millimoles per liter
Standard Deviation 2.23
|
2.0 Millimoles per liter
Standard Deviation 1.58
|
1.8 Millimoles per liter
Standard Deviation 1.58
|
2.8 Millimoles per liter
Standard Deviation 3.11
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Chloride,Week 52,n=9,5,5,5,4
|
4.8 Millimoles per liter
Standard Deviation 1.09
|
2.2 Millimoles per liter
Standard Deviation 1.64
|
0.2 Millimoles per liter
Standard Deviation 3.83
|
3.6 Millimoles per liter
Standard Deviation 1.95
|
3.8 Millimoles per liter
Standard Deviation 4.11
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Glucose,Week 2,n=38,39,26,24,26
|
-0.03 Millimoles per liter
Standard Deviation 2.568
|
-0.46 Millimoles per liter
Standard Deviation 1.671
|
0.01 Millimoles per liter
Standard Deviation 1.237
|
0.29 Millimoles per liter
Standard Deviation 1.358
|
-0.44 Millimoles per liter
Standard Deviation 3.578
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Glucose,Week 8,n=34,31,24,22,23
|
-0.29 Millimoles per liter
Standard Deviation 2.507
|
-0.58 Millimoles per liter
Standard Deviation 2.606
|
-0.12 Millimoles per liter
Standard Deviation 1.265
|
0.10 Millimoles per liter
Standard Deviation 1.579
|
-1.15 Millimoles per liter
Standard Deviation 5.685
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Glucose,Week 12,n=32,28,24,22,21
|
-0.64 Millimoles per liter
Standard Deviation 2.219
|
-0.63 Millimoles per liter
Standard Deviation 2.134
|
-0.33 Millimoles per liter
Standard Deviation 1.163
|
-0.25 Millimoles per liter
Standard Deviation 1.164
|
-1.76 Millimoles per liter
Standard Deviation 5.919
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Glucose,Week 20,n=25,23,19,18,16
|
-0.66 Millimoles per liter
Standard Deviation 2.701
|
-0.46 Millimoles per liter
Standard Deviation 1.550
|
0.46 Millimoles per liter
Standard Deviation 1.714
|
-0.33 Millimoles per liter
Standard Deviation 1.435
|
-1.96 Millimoles per liter
Standard Deviation 7.018
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Glucose,Week 32,n=19,15,10,12,13
|
-0.74 Millimoles per liter
Standard Deviation 3.492
|
-0.48 Millimoles per liter
Standard Deviation 1.533
|
0.72 Millimoles per liter
Standard Deviation 1.795
|
-0.05 Millimoles per liter
Standard Deviation 1.363
|
-3.12 Millimoles per liter
Standard Deviation 7.818
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Glucose,Week 40,n=15,11,9,10,10
|
-0.99 Millimoles per liter
Standard Deviation 3.465
|
-0.33 Millimoles per liter
Standard Deviation 2.376
|
0.22 Millimoles per liter
Standard Deviation 1.203
|
-0.22 Millimoles per liter
Standard Deviation 1.192
|
-0.94 Millimoles per liter
Standard Deviation 3.589
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Glucose,Week 52,n=9,5,5,5,4
|
-1.51 Millimoles per liter
Standard Deviation 4.466
|
-0.94 Millimoles per liter
Standard Deviation 2.707
|
-0.26 Millimoles per liter
Standard Deviation 1.316
|
-0.72 Millimoles per liter
Standard Deviation 1.308
|
0.45 Millimoles per liter
Standard Deviation 2.353
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Phosphate,Week 16,n=28,26,22,19,18
|
0.113 Millimoles per liter
Standard Deviation 0.1976
|
0.139 Millimoles per liter
Standard Deviation 0.2315
|
0.146 Millimoles per liter
Standard Deviation 0.1612
|
0.025 Millimoles per liter
Standard Deviation 0.1589
|
0.039 Millimoles per liter
Standard Deviation 0.2238
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Phosphate,Week 20,n=25,23,19,18,16
|
0.070 Millimoles per liter
Standard Deviation 0.1860
|
0.160 Millimoles per liter
Standard Deviation 0.2436
|
0.141 Millimoles per liter
Standard Deviation 0.2257
|
0.043 Millimoles per liter
Standard Deviation 0.1854
|
0.060 Millimoles per liter
Standard Deviation 0.2183
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Phosphate,Week 40,n=15,11,6,10,10
|
0.221 Millimoles per liter
Standard Deviation 0.1902
|
-0.007 Millimoles per liter
Standard Deviation 0.2007
|
0.104 Millimoles per liter
Standard Deviation 0.1948
|
0.073 Millimoles per liter
Standard Deviation 0.1849
|
0.206 Millimoles per liter
Standard Deviation 0.2151
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Phosphate,Week 48,n=9,8,5,8,5
|
0.029 Millimoles per liter
Standard Deviation 0.2136
|
-0.054 Millimoles per liter
Standard Deviation 0.2203
|
0.028 Millimoles per liter
Standard Deviation 0.2611
|
-0.015 Millimoles per liter
Standard Deviation 0.1561
|
0.132 Millimoles per liter
Standard Deviation 0.1972
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Phosphate,Week 52,n=9,5,5,5,4
|
0.049 Millimoles per liter
Standard Deviation 0.2235
|
-0.036 Millimoles per liter
Standard Deviation 0.2779
|
0.208 Millimoles per liter
Standard Deviation 0.1583
|
0.036 Millimoles per liter
Standard Deviation 0.0865
|
0.115 Millimoles per liter
Standard Deviation 0.1434
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Potassium,Week 2,n=38,39,26,24,26
|
0.03 Millimoles per liter
Standard Deviation 0.372
|
-0.03 Millimoles per liter
Standard Deviation 0.437
|
-0.02 Millimoles per liter
Standard Deviation 0.401
|
0.18 Millimoles per liter
Standard Deviation 0.336
|
0.08 Millimoles per liter
Standard Deviation 0.375
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Potassium,Week 4,n=37,38,25,23,27
|
-0.13 Millimoles per liter
Standard Deviation 0.319
|
-0.04 Millimoles per liter
Standard Deviation 0.412
|
-0.10 Millimoles per liter
Standard Deviation 0.453
|
0.06 Millimoles per liter
Standard Deviation 0.329
|
-0.03 Millimoles per liter
Standard Deviation 0.343
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Potassium,Week 8,n=34,31,24,22,23
|
0.01 Millimoles per liter
Standard Deviation 0.364
|
0.05 Millimoles per liter
Standard Deviation 0.437
|
-0.11 Millimoles per liter
Standard Deviation 0.422
|
0.10 Millimoles per liter
Standard Deviation 0.333
|
0.06 Millimoles per liter
Standard Deviation 0.399
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Potassium,Week 12,n=32,28,24,22,21
|
-0.12 Millimoles per liter
Standard Deviation 0.333
|
0.15 Millimoles per liter
Standard Deviation 0.810
|
-0.10 Millimoles per liter
Standard Deviation 0.346
|
0.06 Millimoles per liter
Standard Deviation 0.336
|
0.04 Millimoles per liter
Standard Deviation 0.446
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Potassium,Week 16,n=28,26,22,19,18
|
0.01 Millimoles per liter
Standard Deviation 0.376
|
0.03 Millimoles per liter
Standard Deviation 0.439
|
-0.02 Millimoles per liter
Standard Deviation 0.358
|
0.15 Millimoles per liter
Standard Deviation 0.345
|
0.15 Millimoles per liter
Standard Deviation 0.279
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Potassium,Week 20,n=25,23,19,18,16
|
0.04 Millimoles per liter
Standard Deviation 0.394
|
0.07 Millimoles per liter
Standard Deviation 0.556
|
0.02 Millimoles per liter
Standard Deviation 0.417
|
0.10 Millimoles per liter
Standard Deviation 0.287
|
0.16 Millimoles per liter
Standard Deviation 0.390
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Potassium,Week 24,n=22,21,16,17,16
|
0.05 Millimoles per liter
Standard Deviation 0.447
|
-0.01 Millimoles per liter
Standard Deviation 0.403
|
-0.13 Millimoles per liter
Standard Deviation 0.368
|
0.15 Millimoles per liter
Standard Deviation 0.371
|
0.16 Millimoles per liter
Standard Deviation 0.411
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Potassium,Week 28,n=19,18,12,13,14
|
0.12 Millimoles per liter
Standard Deviation 0.288
|
0.07 Millimoles per liter
Standard Deviation 0.470
|
0.17 Millimoles per liter
Standard Deviation 0.414
|
0.08 Millimoles per liter
Standard Deviation 0.297
|
0.23 Millimoles per liter
Standard Deviation 0.418
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Potassium,Week 32,n=19,15,10,12,13
|
0.16 Millimoles per liter
Standard Deviation 0.437
|
0.01 Millimoles per liter
Standard Deviation 0.448
|
0.17 Millimoles per liter
Standard Deviation 0.333
|
0.19 Millimoles per liter
Standard Deviation 0.365
|
0.25 Millimoles per liter
Standard Deviation 0.443
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Potassium,Week 36,n=15,12,10,12,13
|
0.16 Millimoles per liter
Standard Deviation 0.429
|
-0.07 Millimoles per liter
Standard Deviation 0.475
|
0.18 Millimoles per liter
Standard Deviation 0.408
|
0.18 Millimoles per liter
Standard Deviation 0.341
|
0.21 Millimoles per liter
Standard Deviation 0.403
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Potassium,Week 40,n=15,11,9,10,10
|
0.24 Millimoles per liter
Standard Deviation 0.534
|
-0.03 Millimoles per liter
Standard Deviation 0.476
|
0.01 Millimoles per liter
Standard Deviation 0.276
|
0.03 Millimoles per liter
Standard Deviation 0.450
|
0.28 Millimoles per liter
Standard Deviation 0.355
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Potassium,Week 44,n=11,11,6,8,9
|
0.16 Millimoles per liter
Standard Deviation 0.287
|
-0.13 Millimoles per liter
Standard Deviation 0.478
|
-0.13 Millimoles per liter
Standard Deviation 0.288
|
0.15 Millimoles per liter
Standard Deviation 0.385
|
0.16 Millimoles per liter
Standard Deviation 0.488
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Potassium,Week 48,n=9,8,5,8,5
|
0.21 Millimoles per liter
Standard Deviation 0.352
|
0.06 Millimoles per liter
Standard Deviation 0.644
|
-0.04 Millimoles per liter
Standard Deviation 0.182
|
0.16 Millimoles per liter
Standard Deviation 0.283
|
0.52 Millimoles per liter
Standard Deviation 0.432
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Potassium,Week 52,n=9,5,5,5,4
|
0.22 Millimoles per liter
Standard Deviation 0.186
|
-0.16 Millimoles per liter
Standard Deviation 0.434
|
-0.10 Millimoles per liter
Standard Deviation 0.418
|
0.06 Millimoles per liter
Standard Deviation 0.445
|
0.20 Millimoles per liter
Standard Deviation 0.365
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Urea,Week 12,n=32,28,24,22,21
|
-0.65 Millimoles per liter
Standard Deviation 1.617
|
-1.20 Millimoles per liter
Standard Deviation 1.778
|
-0.62 Millimoles per liter
Standard Deviation 1.501
|
-1.12 Millimoles per liter
Standard Deviation 1.457
|
-0.35 Millimoles per liter
Standard Deviation 1.316
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Urea,Week 16,n=28,26,22,19,18
|
-0.56 Millimoles per liter
Standard Deviation 2.009
|
-0.52 Millimoles per liter
Standard Deviation 1.612
|
-0.72 Millimoles per liter
Standard Deviation 1.232
|
-0.40 Millimoles per liter
Standard Deviation 1.580
|
-0.07 Millimoles per liter
Standard Deviation 1.701
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Sodium,Week 40,n=15,11,9,10,10
|
0.1 Millimoles per liter
Standard Deviation 2.17
|
1.2 Millimoles per liter
Standard Deviation 2.23
|
-1.2 Millimoles per liter
Standard Deviation 2.49
|
0.5 Millimoles per liter
Standard Deviation 1.58
|
2.9 Millimoles per liter
Standard Deviation 3.07
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Sodium,Week 44,n=11,11,6,8,9
|
0.5 Millimoles per liter
Standard Deviation 1.97
|
0.4 Millimoles per liter
Standard Deviation 2.58
|
-2.0 Millimoles per liter
Standard Deviation 2.53
|
-0.8 Millimoles per liter
Standard Deviation 1.28
|
1.8 Millimoles per liter
Standard Deviation 3.77
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Sodium,Week 48,n=9,8,5,8,5
|
-0.3 Millimoles per liter
Standard Deviation 1.87
|
0.8 Millimoles per liter
Standard Deviation 2.76
|
-0.6 Millimoles per liter
Standard Deviation 2.07
|
0.3 Millimoles per liter
Standard Deviation 1.91
|
1.6 Millimoles per liter
Standard Deviation 2.70
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Sodium,Week 52,n=9,5,5,5,4
|
0.7 Millimoles per liter
Standard Deviation 1.66
|
0.4 Millimoles per liter
Standard Deviation 2.51
|
-0.8 Millimoles per liter
Standard Deviation 3.11
|
1.6 Millimoles per liter
Standard Deviation 1.14
|
3.5 Millimoles per liter
Standard Deviation 3.32
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Urea,Week 2,n=38,39,26,24,26
|
0.05 Millimoles per liter
Standard Deviation 1.210
|
-0.16 Millimoles per liter
Standard Deviation 1.776
|
0.28 Millimoles per liter
Standard Deviation 1.439
|
-0.31 Millimoles per liter
Standard Deviation 1.458
|
-0.32 Millimoles per liter
Standard Deviation 1.240
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Urea,Week 4,n=37,38,25,23,27
|
-0.09 Millimoles per liter
Standard Deviation 1.592
|
-0.61 Millimoles per liter
Standard Deviation 1.514
|
-0.06 Millimoles per liter
Standard Deviation 1.277
|
-0.22 Millimoles per liter
Standard Deviation 1.022
|
-0.27 Millimoles per liter
Standard Deviation 1.700
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Urea,Week 8,n=34,31,24,22,23
|
-0.36 Millimoles per liter
Standard Deviation 1.938
|
-0.99 Millimoles per liter
Standard Deviation 1.826
|
-0.40 Millimoles per liter
Standard Deviation 1.574
|
-0.91 Millimoles per liter
Standard Deviation 0.970
|
-0.34 Millimoles per liter
Standard Deviation 0.965
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Urea,Week 20,n=25,23,19,18,16
|
-0.30 Millimoles per liter
Standard Deviation 1.675
|
-0.70 Millimoles per liter
Standard Deviation 1.379
|
-0.70 Millimoles per liter
Standard Deviation 1.197
|
-0.31 Millimoles per liter
Standard Deviation 1.470
|
-0.77 Millimoles per liter
Standard Deviation 1.900
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Urea,Week 24,n=22,21,16,17,16
|
-0.48 Millimoles per liter
Standard Deviation 1.901
|
-0.22 Millimoles per liter
Standard Deviation 2.044
|
-0.80 Millimoles per liter
Standard Deviation 1.717
|
-0.65 Millimoles per liter
Standard Deviation 1.457
|
-0.64 Millimoles per liter
Standard Deviation 2.019
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Urea,Week 28,n=19,18,12,13,14
|
-0.45 Millimoles per liter
Standard Deviation 1.745
|
-0.42 Millimoles per liter
Standard Deviation 1.510
|
-0.73 Millimoles per liter
Standard Deviation 1.317
|
0.23 Millimoles per liter
Standard Deviation 1.111
|
-0.31 Millimoles per liter
Standard Deviation 1.495
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Urea,Week 32,n=19,15,10,12,13
|
-0.16 Millimoles per liter
Standard Deviation 2.086
|
-0.64 Millimoles per liter
Standard Deviation 1.479
|
-0.83 Millimoles per liter
Standard Deviation 1.382
|
-0.76 Millimoles per liter
Standard Deviation 1.071
|
0.17 Millimoles per liter
Standard Deviation 2.609
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Urea,Week 36,n=15,12,10,12,13
|
0.06 Millimoles per liter
Standard Deviation 1.967
|
-1.43 Millimoles per liter
Standard Deviation 1.828
|
-0.93 Millimoles per liter
Standard Deviation 1.113
|
-0.01 Millimoles per liter
Standard Deviation 0.973
|
-0.22 Millimoles per liter
Standard Deviation 2.297
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Urea,Week 40,n=15,11,9,10,10
|
-0.17 Millimoles per liter
Standard Deviation 1.775
|
-0.78 Millimoles per liter
Standard Deviation 0.603
|
-0.98 Millimoles per liter
Standard Deviation 1.237
|
-0.76 Millimoles per liter
Standard Deviation 1.552
|
0.32 Millimoles per liter
Standard Deviation 1.886
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Urea,Week 44,n=11,11,6,8,9
|
-0.46 Millimoles per liter
Standard Deviation 3.119
|
-1.05 Millimoles per liter
Standard Deviation 1.234
|
-0.63 Millimoles per liter
Standard Deviation 1.359
|
-0.76 Millimoles per liter
Standard Deviation 1.274
|
-1.09 Millimoles per liter
Standard Deviation 1.727
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Urea,Week 48,n=9,8,5,8,5
|
-0.18 Millimoles per liter
Standard Deviation 3.535
|
-1.58 Millimoles per liter
Standard Deviation 1.450
|
-0.06 Millimoles per liter
Standard Deviation 1.311
|
-0.51 Millimoles per liter
Standard Deviation 1.225
|
0.44 Millimoles per liter
Standard Deviation 1.282
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Urea,Week 52,n=9,5,5,5,4
|
-0.26 Millimoles per liter
Standard Deviation 2.508
|
-1.22 Millimoles per liter
Standard Deviation 1.671
|
-0.76 Millimoles per liter
Standard Deviation 1.647
|
-0.82 Millimoles per liter
Standard Deviation 0.782
|
-0.45 Millimoles per liter
Standard Deviation 1.475
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Phosphate,Week 24,n=22,21,16,17,16
|
0.132 Millimoles per liter
Standard Deviation 0.2066
|
0.163 Millimoles per liter
Standard Deviation 0.2383
|
0.181 Millimoles per liter
Standard Deviation 0.1778
|
0.055 Millimoles per liter
Standard Deviation 0.1728
|
0.101 Millimoles per liter
Standard Deviation 0.1811
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Sodium,Week 20,n=25,23,19,18,16
|
1.0 Millimoles per liter
Standard Deviation 2.23
|
0.6 Millimoles per liter
Standard Deviation 2.79
|
-0.3 Millimoles per liter
Standard Deviation 2.60
|
-0.6 Millimoles per liter
Standard Deviation 0.92
|
2.3 Millimoles per liter
Standard Deviation 3.52
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Phosphate,Week 28,n=19,18,12,13,14
|
0.156 Millimoles per liter
Standard Deviation 0.1873
|
0.090 Millimoles per liter
Standard Deviation 0.2543
|
0.191 Millimoles per liter
Standard Deviation 0.1980
|
0.073 Millimoles per liter
Standard Deviation 0.2017
|
0.190 Millimoles per liter
Standard Deviation 0.3143
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Sodium,Week 24,n=22,21,16,17,16
|
0.9 Millimoles per liter
Standard Deviation 2.31
|
1.0 Millimoles per liter
Standard Deviation 1.83
|
-0.4 Millimoles per liter
Standard Deviation 2.00
|
0.4 Millimoles per liter
Standard Deviation 1.50
|
1.9 Millimoles per liter
Standard Deviation 2.96
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Phosphate,Week 32,n=19,15,10,12,13
|
0.164 Millimoles per liter
Standard Deviation 0.1166
|
0.101 Millimoles per liter
Standard Deviation 0.2160
|
0.214 Millimoles per liter
Standard Deviation 0.2086
|
0.048 Millimoles per liter
Standard Deviation 0.1677
|
0.155 Millimoles per liter
Standard Deviation 0.2713
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Phosphate,Week 36,n=15,12,10,12,13
|
0.111 Millimoles per liter
Standard Deviation 0.1786
|
0.068 Millimoles per liter
Standard Deviation 0.2204
|
0.304 Millimoles per liter
Standard Deviation 0.2112
|
0.098 Millimoles per liter
Standard Deviation 0.1939
|
0.151 Millimoles per liter
Standard Deviation 0.2114
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Sodium,Week 12,n=32,28,24,22,21
|
1.8 Millimoles per liter
Standard Deviation 2.46
|
0.5 Millimoles per liter
Standard Deviation 3.90
|
0.6 Millimoles per liter
Standard Deviation 1.76
|
0.5 Millimoles per liter
Standard Deviation 1.79
|
2.1 Millimoles per liter
Standard Deviation 2.37
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
calcium,Week 2,n=38,39,26,24,26
|
0.002 Millimoles per liter
Standard Deviation 0.1056
|
0.006 Millimoles per liter
Standard Deviation 0.0853
|
-0.008 Millimoles per liter
Standard Deviation 0.0817
|
0.008 Millimoles per liter
Standard Deviation 0.1050
|
0.013 Millimoles per liter
Standard Deviation 0.0812
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
calcium,Week 4,n=37,38,25,23,27
|
0.009 Millimoles per liter
Standard Deviation 0.0974
|
0.008 Millimoles per liter
Standard Deviation 0.0968
|
0.013 Millimoles per liter
Standard Deviation 0.0649
|
-0.016 Millimoles per liter
Standard Deviation 0.0922
|
-0.001 Millimoles per liter
Standard Deviation 0.0899
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
calcium,Week 8,n=34,31,24,22,23
|
0.032 Millimoles per liter
Standard Deviation 0.1114
|
0.049 Millimoles per liter
Standard Deviation 0.0879
|
0.005 Millimoles per liter
Standard Deviation 0.0764
|
0.020 Millimoles per liter
Standard Deviation 0.0918
|
0.013 Millimoles per liter
Standard Deviation 0.0615
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
calcium,Week 12,n=32,28,24,22,21
|
0.019 Millimoles per liter
Standard Deviation 0.1200
|
0.072 Millimoles per liter
Standard Deviation 0.0789
|
-0.001 Millimoles per liter
Standard Deviation 0.0750
|
0.011 Millimoles per liter
Standard Deviation 0.0913
|
0.016 Millimoles per liter
Standard Deviation 0.0851
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
calcium,Week 20,n=25,23,19,18,16
|
0.018 Millimoles per liter
Standard Deviation 0.1080
|
0.070 Millimoles per liter
Standard Deviation 0.0987
|
0.032 Millimoles per liter
Standard Deviation 0.0933
|
0.000 Millimoles per liter
Standard Deviation 0.0884
|
0.012 Millimoles per liter
Standard Deviation 0.0932
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
calcium,Week 24,n=22,21,16,17,16
|
0.008 Millimoles per liter
Standard Deviation 0.1029
|
0.064 Millimoles per liter
Standard Deviation 0.0927
|
0.032 Millimoles per liter
Standard Deviation 0.1077
|
-0.002 Millimoles per liter
Standard Deviation 0.0748
|
0.009 Millimoles per liter
Standard Deviation 0.0702
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
calcium,Week 36,n=15,12,10,12,13
|
0.016 Millimoles per liter
Standard Deviation 0.0789
|
0.055 Millimoles per liter
Standard Deviation 0.0773
|
0.075 Millimoles per liter
Standard Deviation 0.0738
|
-0.038 Millimoles per liter
Standard Deviation 0.1025
|
0.053 Millimoles per liter
Standard Deviation 0.0957
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
calcium,Week 44,n=11,11,6,8,9
|
0.042 Millimoles per liter
Standard Deviation 0.1480
|
0.025 Millimoles per liter
Standard Deviation 0.0908
|
-0.002 Millimoles per liter
Standard Deviation 0.0475
|
-0.035 Millimoles per liter
Standard Deviation 0.1638
|
0.054 Millimoles per liter
Standard Deviation 0.1146
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
calcium,Week 52,n=9,5,5,5,4
|
0.013 Millimoles per liter
Standard Deviation 0.0907
|
0.076 Millimoles per liter
Standard Deviation 0.1108
|
0.026 Millimoles per liter
Standard Deviation 0.0747
|
-0.056 Millimoles per liter
Standard Deviation 0.1161
|
0.083 Millimoles per liter
Standard Deviation 0.0624
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Carbon Dioxide,Week 2,n=38,39,26,24,26
|
0.7 Millimoles per liter
Standard Deviation 2.42
|
0.6 Millimoles per liter
Standard Deviation 2.55
|
0.5 Millimoles per liter
Standard Deviation 2.53
|
-0.3 Millimoles per liter
Standard Deviation 2.31
|
0.7 Millimoles per liter
Standard Deviation 2.24
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Carbon Dioxide,Week 4,n=37,38,25,23,27
|
0.1 Millimoles per liter
Standard Deviation 2.03
|
0.2 Millimoles per liter
Standard Deviation 2.68
|
0.4 Millimoles per liter
Standard Deviation 2.69
|
0.2 Millimoles per liter
Standard Deviation 1.75
|
0.1 Millimoles per liter
Standard Deviation 2.83
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Carbon Dioxide,Week 8,n=34,31,24,22,23
|
0.1 Millimoles per liter
Standard Deviation 3.39
|
0.3 Millimoles per liter
Standard Deviation 2.89
|
0.0 Millimoles per liter
Standard Deviation 2.69
|
0.0 Millimoles per liter
Standard Deviation 2.01
|
1.1 Millimoles per liter
Standard Deviation 2.24
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Carbon Dioxide,Week 12,n=32,28,24,22,21
|
0.1 Millimoles per liter
Standard Deviation 2.66
|
0.6 Millimoles per liter
Standard Deviation 2.53
|
-0.4 Millimoles per liter
Standard Deviation 2.28
|
0.0 Millimoles per liter
Standard Deviation 1.94
|
1.2 Millimoles per liter
Standard Deviation 1.73
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Carbon Dioxide,Week 16,n=28,26,22,19,18
|
0.1 Millimoles per liter
Standard Deviation 2.97
|
0.5 Millimoles per liter
Standard Deviation 2.47
|
0.8 Millimoles per liter
Standard Deviation 2.94
|
-0.1 Millimoles per liter
Standard Deviation 1.88
|
0.5 Millimoles per liter
Standard Deviation 2.55
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Carbon Dioxide,Week 20,n=25,23,19,18,16
|
0.1 Millimoles per liter
Standard Deviation 2.98
|
-0.1 Millimoles per liter
Standard Deviation 3.17
|
-0.1 Millimoles per liter
Standard Deviation 2.70
|
-0.3 Millimoles per liter
Standard Deviation 2.83
|
0.5 Millimoles per liter
Standard Deviation 2.68
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Carbon Dioxide,Week 24,n=22,21,16,17,16
|
0.4 Millimoles per liter
Standard Deviation 3.10
|
0.4 Millimoles per liter
Standard Deviation 3.11
|
-0.8 Millimoles per liter
Standard Deviation 2.65
|
0.5 Millimoles per liter
Standard Deviation 2.29
|
-0.2 Millimoles per liter
Standard Deviation 2.61
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Carbon Dioxide,Week 28,n=19,18,12,13,14
|
-1.6 Millimoles per liter
Standard Deviation 2.83
|
0.4 Millimoles per liter
Standard Deviation 3.63
|
-1.0 Millimoles per liter
Standard Deviation 2.04
|
-0.4 Millimoles per liter
Standard Deviation 2.36
|
0.4 Millimoles per liter
Standard Deviation 3.08
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Carbon Dioxide,Week 52,n=9,5,5,5,4
|
-1.1 Millimoles per liter
Standard Deviation 1.76
|
1.2 Millimoles per liter
Standard Deviation 2.68
|
-1.2 Millimoles per liter
Standard Deviation 1.48
|
-0.4 Millimoles per liter
Standard Deviation 1.34
|
1.8 Millimoles per liter
Standard Deviation 2.87
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Carbon Dioxide,Week 36,n=15,12,10,12,13
|
-1.1 Millimoles per liter
Standard Deviation 2.28
|
0.3 Millimoles per liter
Standard Deviation 3.72
|
-0.9 Millimoles per liter
Standard Deviation 1.97
|
-0.3 Millimoles per liter
Standard Deviation 3.63
|
1.0 Millimoles per liter
Standard Deviation 2.16
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Carbon Dioxide,Week 40,n=15,11,6,10,10
|
-1.5 Millimoles per liter
Standard Deviation 3.16
|
0.9 Millimoles per liter
Standard Deviation 3.75
|
-1.7 Millimoles per liter
Standard Deviation 2.35
|
-0.8 Millimoles per liter
Standard Deviation 2.70
|
0.4 Millimoles per liter
Standard Deviation 1.43
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Carbon Dioxide,Week 44,n=11,11,6,8,9
|
-1.7 Millimoles per liter
Standard Deviation 2.72
|
1.6 Millimoles per liter
Standard Deviation 3.50
|
0.0 Millimoles per liter
Standard Deviation 3.03
|
-1.6 Millimoles per liter
Standard Deviation 1.60
|
-0.1 Millimoles per liter
Standard Deviation 2.47
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Carbon Dioxide,Week 48,n=9,8,5,8,5
|
-2.6 Millimoles per liter
Standard Deviation 2.70
|
0.5 Millimoles per liter
Standard Deviation 3.59
|
-1.0 Millimoles per liter
Standard Deviation 2.65
|
0.0 Millimoles per liter
Standard Deviation 1.77
|
-0.2 Millimoles per liter
Standard Deviation 2.17
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Chloride,Week 2,n=38,39,26,24,26
|
1.1 Millimoles per liter
Standard Deviation 2.36
|
0.6 Millimoles per liter
Standard Deviation 1.79
|
0.7 Millimoles per liter
Standard Deviation 1.76
|
1.0 Millimoles per liter
Standard Deviation 2.16
|
0.8 Millimoles per liter
Standard Deviation 2.77
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Chloride,Week 8,n=34,31,24,22,23
|
2.5 Millimoles per liter
Standard Deviation 2.12
|
2.4 Millimoles per liter
Standard Deviation 2.06
|
2.0 Millimoles per liter
Standard Deviation 2.65
|
1.0 Millimoles per liter
Standard Deviation 2.18
|
2.1 Millimoles per liter
Standard Deviation 3.24
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Chloride,Week 12,n=32,28,24,22,21
|
2.9 Millimoles per liter
Standard Deviation 2.54
|
1.8 Millimoles per liter
Standard Deviation 3.03
|
2.4 Millimoles per liter
Standard Deviation 2.30
|
0.6 Millimoles per liter
Standard Deviation 2.06
|
2.0 Millimoles per liter
Standard Deviation 2.36
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Chloride,Week 20,n=25,23,19,18,16
|
3.3 Millimoles per liter
Standard Deviation 2.88
|
2.0 Millimoles per liter
Standard Deviation 2.11
|
2.1 Millimoles per liter
Standard Deviation 2.49
|
1.3 Millimoles per liter
Standard Deviation 2.22
|
2.5 Millimoles per liter
Standard Deviation 3.12
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Chloride,Week 24,n=22,21,16,17,16
|
3.4 Millimoles per liter
Standard Deviation 3.42
|
2.7 Millimoles per liter
Standard Deviation 2.51
|
1.6 Millimoles per liter
Standard Deviation 3.16
|
1.0 Millimoles per liter
Standard Deviation 2.12
|
2.3 Millimoles per liter
Standard Deviation 3.55
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Chloride,Week 28,n=19,18,12,13,14
|
3.9 Millimoles per liter
Standard Deviation 3.13
|
2.8 Millimoles per liter
Standard Deviation 2.80
|
2.8 Millimoles per liter
Standard Deviation 2.49
|
0.2 Millimoles per liter
Standard Deviation 3.49
|
2.9 Millimoles per liter
Standard Deviation 3.63
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Phosphate,Week 4,n=37,38,25,23,27
|
0.071 Millimoles per liter
Standard Deviation 0.1944
|
-0.011 Millimoles per liter
Standard Deviation 0.2501
|
0.093 Millimoles per liter
Standard Deviation 0.1848
|
0.006 Millimoles per liter
Standard Deviation 0.1883
|
0.008 Millimoles per liter
Standard Deviation 0.2087
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Phosphate,Week 8,n=34,31,24,22,23
|
0.088 Millimoles per liter
Standard Deviation 0.1786
|
0.091 Millimoles per liter
Standard Deviation 0.2098
|
0.112 Millimoles per liter
Standard Deviation 0.1588
|
0.045 Millimoles per liter
Standard Deviation 0.1971
|
0.055 Millimoles per liter
Standard Deviation 0.1746
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Phosphate,Week 12,n=32,28,24,22,21
|
0.122 Millimoles per liter
Standard Deviation 0.2404
|
0.154 Millimoles per liter
Standard Deviation 0.2377
|
0.190 Millimoles per liter
Standard Deviation 0.1725
|
0.067 Millimoles per liter
Standard Deviation 0.1873
|
0.079 Millimoles per liter
Standard Deviation 0.1946
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Chloride,Week 32,n=19,15,10,12,13
|
3.4 Millimoles per liter
Standard Deviation 2.73
|
1.9 Millimoles per liter
Standard Deviation 2.59
|
2.0 Millimoles per liter
Standard Deviation 2.26
|
-0.1 Millimoles per liter
Standard Deviation 4.17
|
3.4 Millimoles per liter
Standard Deviation 3.43
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Chloride,Week 44,n=11,11,6,8,9
|
3.8 Millimoles per liter
Standard Deviation 2.23
|
3.4 Millimoles per liter
Standard Deviation 1.91
|
0.2 Millimoles per liter
Standard Deviation 2.14
|
1.1 Millimoles per liter
Standard Deviation 2.03
|
2.2 Millimoles per liter
Standard Deviation 4.52
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Glucose,Week 4,n=37,38,25,23,27
|
-0.10 Millimoles per liter
Standard Deviation 2.676
|
-0.35 Millimoles per liter
Standard Deviation 1.929
|
0.38 Millimoles per liter
Standard Deviation 1.601
|
0.31 Millimoles per liter
Standard Deviation 1.466
|
-0.03 Millimoles per liter
Standard Deviation 4.387
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Glucose,Week 16,n=28,26,22,19,18
|
-0.71 Millimoles per liter
Standard Deviation 2.485
|
0.33 Millimoles per liter
Standard Deviation 1.941
|
-0.29 Millimoles per liter
Standard Deviation 1.113
|
-0.12 Millimoles per liter
Standard Deviation 1.414
|
-1.15 Millimoles per liter
Standard Deviation 6.411
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Glucose,Week 24,n=22,21,16,17,16
|
-0.72 Millimoles per liter
Standard Deviation 2.701
|
-0.44 Millimoles per liter
Standard Deviation 1.632
|
-0.23 Millimoles per liter
Standard Deviation 1.217
|
-0.38 Millimoles per liter
Standard Deviation 1.290
|
-2.08 Millimoles per liter
Standard Deviation 6.953
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Glucose,Week 28,n=19,18,12,13,14
|
-0.91 Millimoles per liter
Standard Deviation 2.990
|
-0.32 Millimoles per liter
Standard Deviation 1.510
|
0.58 Millimoles per liter
Standard Deviation 1.627
|
-0.25 Millimoles per liter
Standard Deviation 1.278
|
-2.05 Millimoles per liter
Standard Deviation 7.699
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Glucose,Week 36,n=15,12,10,12,13
|
-1.14 Millimoles per liter
Standard Deviation 3.268
|
-0.35 Millimoles per liter
Standard Deviation 1.861
|
0.05 Millimoles per liter
Standard Deviation 1.019
|
-0.50 Millimoles per liter
Standard Deviation 1.261
|
-2.98 Millimoles per liter
Standard Deviation 7.786
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Glucose,Week 44,n=11,11,6,8,9
|
-1.39 Millimoles per liter
Standard Deviation 3.789
|
-0.05 Millimoles per liter
Standard Deviation 1.954
|
-0.27 Millimoles per liter
Standard Deviation 0.940
|
0.30 Millimoles per liter
Standard Deviation 0.739
|
-0.23 Millimoles per liter
Standard Deviation 2.001
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea
Phosphate,Week 2,n=38,39,26,24,26
|
0.056 Millimoles per liter
Standard Deviation 0.2249
|
-0.004 Millimoles per liter
Standard Deviation 0.1930
|
0.017 Millimoles per liter
Standard Deviation 0.1886
|
-0.025 Millimoles per liter
Standard Deviation 0.1622
|
0.005 Millimoles per liter
Standard Deviation 0.1601
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin,Week 2,n=38,39,26,24,26
|
0.3 Grams per liter
Standard Deviation 2.29
|
0.9 Grams per liter
Standard Deviation 1.79
|
0.8 Grams per liter
Standard Deviation 1.88
|
-0.9 Grams per liter
Standard Deviation 2.64
|
-0.7 Grams per liter
Standard Deviation 2.24
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin,Week 4,n=37,38,25,23,27
|
0.9 Grams per liter
Standard Deviation 2.41
|
2.0 Grams per liter
Standard Deviation 2.84
|
1.6 Grams per liter
Standard Deviation 1.50
|
-1.4 Grams per liter
Standard Deviation 2.46
|
-0.9 Grams per liter
Standard Deviation 2.46
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin,Week 8,n=34,31,24,22,23
|
1.9 Grams per liter
Standard Deviation 2.76
|
3.1 Grams per liter
Standard Deviation 2.35
|
2.1 Grams per liter
Standard Deviation 1.85
|
-1.1 Grams per liter
Standard Deviation 2.35
|
-0.6 Grams per liter
Standard Deviation 1.80
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin,Week 12,n=32,28,24,22,21
|
2.0 Grams per liter
Standard Deviation 2.26
|
3.4 Grams per liter
Standard Deviation 2.50
|
3.1 Grams per liter
Standard Deviation 1.54
|
-0.5 Grams per liter
Standard Deviation 2.81
|
0.2 Grams per liter
Standard Deviation 1.87
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin,Week 16,n=28,26,22,19,18
|
1.7 Grams per liter
Standard Deviation 2.29
|
2.8 Grams per liter
Standard Deviation 2.52
|
2.8 Grams per liter
Standard Deviation 2.44
|
-1.2 Grams per liter
Standard Deviation 2.41
|
0.6 Grams per liter
Standard Deviation 2.48
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin,Week 20,n=25,23,19,18,16
|
1.8 Grams per liter
Standard Deviation 2.46
|
3.9 Grams per liter
Standard Deviation 2.68
|
2.8 Grams per liter
Standard Deviation 2.15
|
-0.9 Grams per liter
Standard Deviation 2.70
|
0.3 Grams per liter
Standard Deviation 2.11
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin,Week 24,n=22,21,16,17,16
|
1.6 Grams per liter
Standard Deviation 2.77
|
3.8 Grams per liter
Standard Deviation 2.36
|
3.7 Grams per liter
Standard Deviation 1.85
|
0.0 Grams per liter
Standard Deviation 2.83
|
0.3 Grams per liter
Standard Deviation 1.88
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin,Week 36,n=15,12,10,12,13
|
3.1 Grams per liter
Standard Deviation 2.61
|
4.3 Grams per liter
Standard Deviation 3.75
|
2.9 Grams per liter
Standard Deviation 2.08
|
-1.3 Grams per liter
Standard Deviation 3.25
|
0.2 Grams per liter
Standard Deviation 3.02
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin,Week 40,n=15,11,9,10,10
|
3.2 Grams per liter
Standard Deviation 1.97
|
3.9 Grams per liter
Standard Deviation 3.78
|
2.4 Grams per liter
Standard Deviation 2.07
|
-1.1 Grams per liter
Standard Deviation 2.96
|
-0.5 Grams per liter
Standard Deviation 2.27
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin,Week 44,n=11,11,6,8,9
|
3.2 Grams per liter
Standard Deviation 2.36
|
4.1 Grams per liter
Standard Deviation 3.36
|
2.2 Grams per liter
Standard Deviation 2.23
|
0.4 Grams per liter
Standard Deviation 3.07
|
0.6 Grams per liter
Standard Deviation 2.19
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin,Week 48,n=9,8,5,8,5
|
3.4 Grams per liter
Standard Deviation 2.13
|
4.4 Grams per liter
Standard Deviation 3.20
|
1.6 Grams per liter
Standard Deviation 2.70
|
-0.8 Grams per liter
Standard Deviation 3.28
|
2.0 Grams per liter
Standard Deviation 2.92
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin,Week 52,n=9,5,5,5,4
|
3.7 Grams per liter
Standard Deviation 2.45
|
5.2 Grams per liter
Standard Deviation 1.64
|
4.0 Grams per liter
Standard Deviation 2.55
|
-1.2 Grams per liter
Standard Deviation 0.84
|
1.5 Grams per liter
Standard Deviation 4.12
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein,Week 2,n=38,39,26,24,26
|
-2.6 Grams per liter
Standard Deviation 3.68
|
-2.4 Grams per liter
Standard Deviation 3.13
|
-1.9 Grams per liter
Standard Deviation 2.73
|
-1.7 Grams per liter
Standard Deviation 3.31
|
-1.7 Grams per liter
Standard Deviation 3.16
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein,Week 4,n=37,38,25,23,27
|
-2.5 Grams per liter
Standard Deviation 3.49
|
-2.4 Grams per liter
Standard Deviation 4.39
|
-1.8 Grams per liter
Standard Deviation 2.81
|
-2.0 Grams per liter
Standard Deviation 3.64
|
-2.0 Grams per liter
Standard Deviation 4.05
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein,Week 8,n=34,31,24,22,23
|
-1.9 Grams per liter
Standard Deviation 3.53
|
-1.6 Grams per liter
Standard Deviation 4.16
|
-2.2 Grams per liter
Standard Deviation 3.67
|
-0.7 Grams per liter
Standard Deviation 3.10
|
-0.7 Grams per liter
Standard Deviation 3.30
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein,Week 12,n=32,28,24,22,21
|
-1.7 Grams per liter
Standard Deviation 3.19
|
-1.3 Grams per liter
Standard Deviation 3.72
|
-0.8 Grams per liter
Standard Deviation 3.06
|
1.0 Grams per liter
Standard Deviation 3.68
|
0.9 Grams per liter
Standard Deviation 3.67
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein,Week 24,n=22,21,16,17,16
|
-1.1 Grams per liter
Standard Deviation 3.64
|
-0.9 Grams per liter
Standard Deviation 4.39
|
0.0 Grams per liter
Standard Deviation 2.85
|
1.5 Grams per liter
Standard Deviation 4.86
|
0.8 Grams per liter
Standard Deviation 3.09
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein,Week 28,n=19,18,12,13,14
|
-2.4 Grams per liter
Standard Deviation 3.30
|
-0.8 Grams per liter
Standard Deviation 5.27
|
-2.7 Grams per liter
Standard Deviation 2.67
|
-0.2 Grams per liter
Standard Deviation 4.39
|
1.6 Grams per liter
Standard Deviation 4.20
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein,Week 32,n=19,15,10,12,13
|
-1.4 Grams per liter
Standard Deviation 3.52
|
-1.5 Grams per liter
Standard Deviation 4.67
|
-2.1 Grams per liter
Standard Deviation 4.07
|
-0.3 Grams per liter
Standard Deviation 4.45
|
2.6 Grams per liter
Standard Deviation 3.78
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein,Week 36,n=15,12,10,12,13
|
-0.3 Grams per liter
Standard Deviation 3.48
|
-0.8 Grams per liter
Standard Deviation 4.69
|
-0.5 Grams per liter
Standard Deviation 2.51
|
-0.3 Grams per liter
Standard Deviation 4.11
|
1.8 Grams per liter
Standard Deviation 3.51
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein,Week 48,n=9,8,5,8,5
|
0.3 Grams per liter
Standard Deviation 4.69
|
-0.1 Grams per liter
Standard Deviation 3.76
|
-1.8 Grams per liter
Standard Deviation 4.49
|
1.4 Grams per liter
Standard Deviation 4.98
|
3.2 Grams per liter
Standard Deviation 2.28
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein,Week 52,n=9,5,5,5,4
|
-0.4 Grams per liter
Standard Deviation 3.54
|
1.0 Grams per liter
Standard Deviation 4.69
|
0.6 Grams per liter
Standard Deviation 4.88
|
-1.0 Grams per liter
Standard Deviation 3.54
|
1.8 Grams per liter
Standard Deviation 4.43
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin,Week 28,n=19,18,12,13,14
|
1.5 Grams per liter
Standard Deviation 1.61
|
3.5 Grams per liter
Standard Deviation 3.38
|
2.4 Grams per liter
Standard Deviation 2.78
|
-0.5 Grams per liter
Standard Deviation 2.82
|
0.4 Grams per liter
Standard Deviation 2.98
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Albumin,Week 32,n=19,15,10,12,13
|
2.2 Grams per liter
Standard Deviation 2.03
|
3.6 Grams per liter
Standard Deviation 3.68
|
2.2 Grams per liter
Standard Deviation 2.66
|
-0.7 Grams per liter
Standard Deviation 3.20
|
1.1 Grams per liter
Standard Deviation 2.93
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein,Week 16,n=28,26,22,19,18
|
-2.3 Grams per liter
Standard Deviation 3.43
|
-2.0 Grams per liter
Standard Deviation 3.67
|
-1.9 Grams per liter
Standard Deviation 3.70
|
0.2 Grams per liter
Standard Deviation 3.20
|
1.0 Grams per liter
Standard Deviation 3.68
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein,Week 20,n=25,23,19,18,16
|
-1.9 Grams per liter
Standard Deviation 3.44
|
-0.4 Grams per liter
Standard Deviation 4.69
|
-1.3 Grams per liter
Standard Deviation 2.84
|
0.6 Grams per liter
Standard Deviation 3.45
|
0.4 Grams per liter
Standard Deviation 2.63
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein,Week 40,n=15,11,9,10,10
|
-0.5 Grams per liter
Standard Deviation 3.38
|
-1.5 Grams per liter
Standard Deviation 4.93
|
-2.1 Grams per liter
Standard Deviation 1.76
|
-0.4 Grams per liter
Standard Deviation 3.27
|
1.4 Grams per liter
Standard Deviation 3.03
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein
Protein,Week 44,n=11,11,6,8,9
|
0.3 Grams per liter
Standard Deviation 2.65
|
-0.4 Grams per liter
Standard Deviation 4.06
|
-2.0 Grams per liter
Standard Deviation 3.52
|
2.3 Grams per liter
Standard Deviation 5.50
|
1.7 Grams per liter
Standard Deviation 2.60
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT,Week 16,n=28,26,22,19,18
|
4.1 International units per liter
Standard Deviation 8.11
|
2.2 International units per liter
Standard Deviation 9.86
|
5.2 International units per liter
Standard Deviation 10.08
|
-3.5 International units per liter
Standard Deviation 5.23
|
-6.6 International units per liter
Standard Deviation 14.22
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT,Week 12,n=32,28,24,22,21
|
4.7 International units per liter
Standard Deviation 6.91
|
4.4 International units per liter
Standard Deviation 10.82
|
4.0 International units per liter
Standard Deviation 6.85
|
-3.3 International units per liter
Standard Deviation 5.39
|
-7.0 International units per liter
Standard Deviation 11.88
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT,Week 4,n=37,38,25,23,27
|
6.6 International units per liter
Standard Deviation 11.17
|
6.6 International units per liter
Standard Deviation 16.09
|
5.2 International units per liter
Standard Deviation 6.10
|
-1.2 International units per liter
Standard Deviation 4.20
|
-3.1 International units per liter
Standard Deviation 9.80
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT,Week 8,n=34,31,24,22,23
|
6.0 International units per liter
Standard Deviation 14.70
|
9.5 International units per liter
Standard Deviation 12.71
|
4.7 International units per liter
Standard Deviation 8.25
|
-2.8 International units per liter
Standard Deviation 4.19
|
-6.8 International units per liter
Standard Deviation 12.81
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT,Week 2,n=38,39,26,24,26
|
8.2 International units per liter
Standard Deviation 17.71
|
5.3 International units per liter
Standard Deviation 14.63
|
10.1 International units per liter
Standard Deviation 23.12
|
-0.6 International units per liter
Standard Deviation 3.27
|
1.8 International units per liter
Standard Deviation 15.16
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT,Week 20,n=25,23,19,18,16
|
16.1 International units per liter
Standard Deviation 51.67
|
4.9 International units per liter
Standard Deviation 15.83
|
8.6 International units per liter
Standard Deviation 11.73
|
2.3 International units per liter
Standard Deviation 22.33
|
-8.1 International units per liter
Standard Deviation 14.38
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT,Week 24,n=22,21,16,17,16
|
8.3 International units per liter
Standard Deviation 13.62
|
2.5 International units per liter
Standard Deviation 14.71
|
16.4 International units per liter
Standard Deviation 33.68
|
-2.8 International units per liter
Standard Deviation 6.58
|
-9.4 International units per liter
Standard Deviation 13.61
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT,Week 28,n=19,18,12,13,14
|
6.7 International units per liter
Standard Deviation 8.75
|
2.9 International units per liter
Standard Deviation 14.59
|
12.1 International units per liter
Standard Deviation 23.96
|
-1.9 International units per liter
Standard Deviation 3.95
|
-8.9 International units per liter
Standard Deviation 12.65
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT,Week 32,n=19,15,10,12,13
|
6.6 International units per liter
Standard Deviation 11.06
|
5.0 International units per liter
Standard Deviation 14.05
|
5.1 International units per liter
Standard Deviation 9.45
|
-2.0 International units per liter
Standard Deviation 4.45
|
-10.0 International units per liter
Standard Deviation 12.40
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT,Week 36,n=15,12,10,12,13
|
8.7 International units per liter
Standard Deviation 13.58
|
6.0 International units per liter
Standard Deviation 15.22
|
4.5 International units per liter
Standard Deviation 8.44
|
-2.8 International units per liter
Standard Deviation 2.77
|
-10.0 International units per liter
Standard Deviation 13.87
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT,Week 48,n=9,8,5,8,5
|
2.3 International units per liter
Standard Deviation 6.54
|
4.5 International units per liter
Standard Deviation 16.52
|
3.6 International units per liter
Standard Deviation 10.48
|
-3.5 International units per liter
Standard Deviation 3.12
|
0.2 International units per liter
Standard Deviation 11.50
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT,Week 52,n=9,5,5,5,4
|
1.3 International units per liter
Standard Deviation 5.98
|
1.6 International units per liter
Standard Deviation 19.63
|
8.8 International units per liter
Standard Deviation 10.03
|
-4.4 International units per liter
Standard Deviation 1.52
|
5.3 International units per liter
Standard Deviation 20.81
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP,Week 52,n=9,5,5,5,4
|
-26.0 International units per liter
Standard Deviation 29.20
|
-8.0 International units per liter
Standard Deviation 9.14
|
-3.6 International units per liter
Standard Deviation 7.60
|
1.0 International units per liter
Standard Deviation 19.34
|
-1.5 International units per liter
Standard Deviation 11.00
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST,Week 28,n=19,18,12,13,14
|
9.0 International units per liter
Standard Deviation 7.23
|
8.1 International units per liter
Standard Deviation 7.30
|
9.4 International units per liter
Standard Deviation 10.61
|
1.1 International units per liter
Standard Deviation 3.88
|
-0.1 International units per liter
Standard Deviation 9.01
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST,Week 24,n=22,21,16,17,16
|
9.8 International units per liter
Standard Deviation 8.52
|
7.6 International units per liter
Standard Deviation 6.75
|
10.5 International units per liter
Standard Deviation 10.02
|
0.6 International units per liter
Standard Deviation 4.40
|
-1.3 International units per liter
Standard Deviation 8.29
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT,Week 40,n=15,11,9,10,10
|
5.3 International units per liter
Standard Deviation 8.85
|
7.3 International units per liter
Standard Deviation 19.52
|
5.4 International units per liter
Standard Deviation 5.61
|
0.1 International units per liter
Standard Deviation 11.82
|
-2.1 International units per liter
Standard Deviation 6.77
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALT,Week 44,n=11,11,6,8,9
|
1.8 International units per liter
Standard Deviation 5.51
|
5.5 International units per liter
Standard Deviation 15.53
|
2.7 International units per liter
Standard Deviation 7.09
|
-0.4 International units per liter
Standard Deviation 7.15
|
-7.0 International units per liter
Standard Deviation 4.42
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP,Week 2,n=38,39,26,24,26
|
-9.3 International units per liter
Standard Deviation 15.76
|
-11.4 International units per liter
Standard Deviation 7.46
|
-11.4 International units per liter
Standard Deviation 8.50
|
-3.0 International units per liter
Standard Deviation 5.88
|
-2.6 International units per liter
Standard Deviation 5.81
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP,Week 4,n=37,38,25,23,27
|
-15.5 International units per liter
Standard Deviation 13.96
|
-13.4 International units per liter
Standard Deviation 12.75
|
-14.2 International units per liter
Standard Deviation 10.17
|
-2.2 International units per liter
Standard Deviation 8.83
|
5.3 International units per liter
Standard Deviation 27.51
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP,Week 8,n=34,31,24,22,23
|
-16.8 International units per liter
Standard Deviation 11.61
|
-10.4 International units per liter
Standard Deviation 13.73
|
-15.3 International units per liter
Standard Deviation 7.14
|
2.9 International units per liter
Standard Deviation 9.95
|
1.6 International units per liter
Standard Deviation 33.37
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP,Week 12,n=32,28,24,22,21
|
-19.2 International units per liter
Standard Deviation 15.60
|
-7.0 International units per liter
Standard Deviation 10.15
|
-15.0 International units per liter
Standard Deviation 8.06
|
6.6 International units per liter
Standard Deviation 13.21
|
-5.3 International units per liter
Standard Deviation 16.83
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP,Week 16,n=28,26,22,19,18
|
-18.2 International units per liter
Standard Deviation 15.36
|
-8.0 International units per liter
Standard Deviation 12.61
|
-14.6 International units per liter
Standard Deviation 8.56
|
1.1 International units per liter
Standard Deviation 12.90
|
-0.3 International units per liter
Standard Deviation 14.43
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP,Week 20,n=25,23,19,18,16
|
-14.4 International units per liter
Standard Deviation 21.82
|
-4.4 International units per liter
Standard Deviation 12.89
|
-13.3 International units per liter
Standard Deviation 9.58
|
5.9 International units per liter
Standard Deviation 19.44
|
-1.0 International units per liter
Standard Deviation 12.41
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP,Week 24,n=22,21,16,17,16
|
-16.3 International units per liter
Standard Deviation 20.32
|
-6.2 International units per liter
Standard Deviation 13.76
|
-12.5 International units per liter
Standard Deviation 9.08
|
6.9 International units per liter
Standard Deviation 16.34
|
-1.8 International units per liter
Standard Deviation 20.27
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP,Week 28,n=19,18,12,13,14
|
-17.6 International units per liter
Standard Deviation 23.06
|
-4.3 International units per liter
Standard Deviation 14.99
|
-17.5 International units per liter
Standard Deviation 6.56
|
1.6 International units per liter
Standard Deviation 13.28
|
2.9 International units per liter
Standard Deviation 19.72
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP,Week 32,n=19,15,10,12,13
|
-15.9 International units per liter
Standard Deviation 22.94
|
-6.1 International units per liter
Standard Deviation 11.89
|
-12.6 International units per liter
Standard Deviation 6.93
|
-2.3 International units per liter
Standard Deviation 17.00
|
5.2 International units per liter
Standard Deviation 18.44
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP,Week 36,n=15,12,10,12,13
|
-20.3 International units per liter
Standard Deviation 24.22
|
-7.3 International units per liter
Standard Deviation 11.18
|
-9.6 International units per liter
Standard Deviation 12.51
|
-1.8 International units per liter
Standard Deviation 15.49
|
7.3 International units per liter
Standard Deviation 20.95
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP,Week 40,n=15,11,9,10,10
|
-14.5 International units per liter
Standard Deviation 22.71
|
-7.4 International units per liter
Standard Deviation 10.16
|
-9.9 International units per liter
Standard Deviation 11.35
|
-0.2 International units per liter
Standard Deviation 15.17
|
12.3 International units per liter
Standard Deviation 24.69
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP,Week 44,n=11,11,6,8,9
|
-19.4 International units per liter
Standard Deviation 24.30
|
-6.2 International units per liter
Standard Deviation 13.48
|
-4.0 International units per liter
Standard Deviation 10.86
|
2.8 International units per liter
Standard Deviation 19.93
|
11.9 International units per liter
Standard Deviation 24.93
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
ALP,Week 48,n=9,8,5,8,5
|
-24.4 International units per liter
Standard Deviation 28.77
|
-6.5 International units per liter
Standard Deviation 8.45
|
-4.4 International units per liter
Standard Deviation 12.82
|
1.5 International units per liter
Standard Deviation 18.31
|
7.2 International units per liter
Standard Deviation 17.06
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST,Week 2,n=38,39,26,24,26
|
6.1 International units per liter
Standard Deviation 8.07
|
3.7 International units per liter
Standard Deviation 4.81
|
4.5 International units per liter
Standard Deviation 7.11
|
-0.3 International units per liter
Standard Deviation 2.66
|
0.4 International units per liter
Standard Deviation 6.18
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST,Week 4,n=37,38,25,23,27
|
5.4 International units per liter
Standard Deviation 8.43
|
5.9 International units per liter
Standard Deviation 6.74
|
5.0 International units per liter
Standard Deviation 3.96
|
-1.0 International units per liter
Standard Deviation 2.75
|
-0.7 International units per liter
Standard Deviation 7.10
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST,Week 8,n=34,31,24,22,23
|
6.4 International units per liter
Standard Deviation 6.43
|
10.6 International units per liter
Standard Deviation 8.90
|
6.7 International units per liter
Standard Deviation 7.90
|
0.1 International units per liter
Standard Deviation 2.74
|
-1.6 International units per liter
Standard Deviation 7.72
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST,Week 12,n=32,28,24,22,21
|
7.6 International units per liter
Standard Deviation 9.02
|
9.0 International units per liter
Standard Deviation 5.64
|
6.5 International units per liter
Standard Deviation 5.24
|
0.5 International units per liter
Standard Deviation 3.62
|
0.1 International units per liter
Standard Deviation 8.74
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST,Week 16,n=28,26,22,19,18
|
8.5 International units per liter
Standard Deviation 8.94
|
7.0 International units per liter
Standard Deviation 5.79
|
8.0 International units per liter
Standard Deviation 7.28
|
0.2 International units per liter
Standard Deviation 4.45
|
1.0 International units per liter
Standard Deviation 11.88
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST,Week 20,n=25,23,19,18,16
|
14.6 International units per liter
Standard Deviation 27.52
|
7.7 International units per liter
Standard Deviation 7.24
|
9.0 International units per liter
Standard Deviation 7.46
|
4.3 International units per liter
Standard Deviation 20.22
|
1.4 International units per liter
Standard Deviation 12.10
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST,Week 32,n=19,15,10,12,13
|
8.8 International units per liter
Standard Deviation 7.63
|
9.2 International units per liter
Standard Deviation 7.72
|
8.0 International units per liter
Standard Deviation 4.94
|
0.6 International units per liter
Standard Deviation 3.65
|
1.2 International units per liter
Standard Deviation 9.49
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST,Week 36,n=15,12,10,12,13
|
10.6 International units per liter
Standard Deviation 8.85
|
10.8 International units per liter
Standard Deviation 8.09
|
7.6 International units per liter
Standard Deviation 5.02
|
1.3 International units per liter
Standard Deviation 2.56
|
0.2 International units per liter
Standard Deviation 9.27
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST,Week 40,n=15,11,9,10,10
|
8.9 International units per liter
Standard Deviation 4.56
|
8.7 International units per liter
Standard Deviation 10.82
|
9.1 International units per liter
Standard Deviation 4.11
|
4.7 International units per liter
Standard Deviation 13.17
|
6.7 International units per liter
Standard Deviation 11.36
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST,Week 44,n=11,11,6,8,9
|
8.1 International units per liter
Standard Deviation 3.56
|
9.2 International units per liter
Standard Deviation 8.91
|
8.3 International units per liter
Standard Deviation 5.09
|
3.5 International units per liter
Standard Deviation 4.81
|
2.3 International units per liter
Standard Deviation 3.24
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST,Week 48,n=9,8,5,8,5
|
8.1 International units per liter
Standard Deviation 4.04
|
11.8 International units per liter
Standard Deviation 12.63
|
9.8 International units per liter
Standard Deviation 7.29
|
1.3 International units per liter
Standard Deviation 4.68
|
6.4 International units per liter
Standard Deviation 5.59
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)
AST,Week 52,n=9,5,5,5,4
|
7.1 International units per liter
Standard Deviation 3.33
|
9.2 International units per liter
Standard Deviation 4.97
|
11.6 International units per liter
Standard Deviation 5.68
|
-0.2 International units per liter
Standard Deviation 3.63
|
4.3 International units per liter
Standard Deviation 6.85
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected to analyze the chemistry parameters including bilirubin, creatinine, direct bilirubin and indirect bilirubin. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=42 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=39 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=26 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=27 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Creatinine,,Week 52,n=9,5,5,5,4
|
3.56 Micromoles per liter
Standard Deviation 6.903
|
-5.10 Micromoles per liter
Standard Deviation 30.563
|
4.20 Micromoles per liter
Standard Deviation 9.195
|
1.78 Micromoles per liter
Standard Deviation 9.836
|
12.23 Micromoles per liter
Standard Deviation 16.814
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Bilirubin,Week 2,n=38,39,26,24,26
|
1.8 Micromoles per liter
Standard Deviation 2.73
|
1.5 Micromoles per liter
Standard Deviation 3.12
|
1.9 Micromoles per liter
Standard Deviation 3.73
|
-1.1 Micromoles per liter
Standard Deviation 1.94
|
-1.0 Micromoles per liter
Standard Deviation 3.45
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Bilirubin,Week 4,n=37,38,25,23,27
|
2.4 Micromoles per liter
Standard Deviation 5.05
|
1.9 Micromoles per liter
Standard Deviation 3.10
|
1.8 Micromoles per liter
Standard Deviation 2.76
|
-1.8 Micromoles per liter
Standard Deviation 2.52
|
-1.5 Micromoles per liter
Standard Deviation 5.22
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Bilirubin,Week 8,n=34,31,24,22,23
|
3.0 Micromoles per liter
Standard Deviation 3.58
|
2.8 Micromoles per liter
Standard Deviation 4.81
|
0.9 Micromoles per liter
Standard Deviation 2.95
|
-2.3 Micromoles per liter
Standard Deviation 2.50
|
-3.2 Micromoles per liter
Standard Deviation 5.31
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Bilirubin,Week 12,n=32,28,24,22,21
|
4.3 Micromoles per liter
Standard Deviation 8.49
|
2.8 Micromoles per liter
Standard Deviation 3.58
|
2.7 Micromoles per liter
Standard Deviation 3.44
|
-1.0 Micromoles per liter
Standard Deviation 2.40
|
-2.9 Micromoles per liter
Standard Deviation 4.52
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Bilirubin,Week 16,n=28,26,22,19,18
|
2.7 Micromoles per liter
Standard Deviation 4.68
|
4.4 Micromoles per liter
Standard Deviation 4.53
|
3.9 Micromoles per liter
Standard Deviation 3.50
|
-0.9 Micromoles per liter
Standard Deviation 1.85
|
-3.3 Micromoles per liter
Standard Deviation 4.25
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Bilirubin,Week 20,n=25,23,19,18,16
|
4.7 Micromoles per liter
Standard Deviation 9.09
|
4.3 Micromoles per liter
Standard Deviation 4.36
|
3.6 Micromoles per liter
Standard Deviation 3.58
|
-1.4 Micromoles per liter
Standard Deviation 2.20
|
-3.1 Micromoles per liter
Standard Deviation 4.67
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Bilirubin,Week 24,n=22,21,16,17,16
|
4.9 Micromoles per liter
Standard Deviation 6.29
|
3.0 Micromoles per liter
Standard Deviation 4.41
|
4.8 Micromoles per liter
Standard Deviation 3.60
|
-1.1 Micromoles per liter
Standard Deviation 1.80
|
-1.7 Micromoles per liter
Standard Deviation 3.34
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Bilirubin,Week 28,n=19,18,12,13,14
|
4.4 Micromoles per liter
Standard Deviation 5.86
|
3.7 Micromoles per liter
Standard Deviation 3.77
|
3.1 Micromoles per liter
Standard Deviation 3.18
|
-0.8 Micromoles per liter
Standard Deviation 1.92
|
-3.2 Micromoles per liter
Standard Deviation 3.72
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Bilirubin,Week 32,n=19,15,10,12,13
|
4.2 Micromoles per liter
Standard Deviation 4.95
|
4.0 Micromoles per liter
Standard Deviation 4.54
|
2.7 Micromoles per liter
Standard Deviation 2.91
|
-0.8 Micromoles per liter
Standard Deviation 2.53
|
-3.0 Micromoles per liter
Standard Deviation 3.74
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Bilirubin,Week 36,n=15,12,10,12,13
|
5.2 Micromoles per liter
Standard Deviation 4.66
|
5.3 Micromoles per liter
Standard Deviation 5.42
|
2.3 Micromoles per liter
Standard Deviation 2.91
|
-0.9 Micromoles per liter
Standard Deviation 1.88
|
-2.1 Micromoles per liter
Standard Deviation 4.91
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Bilirubin,Week 40,n=15,11,6,10,10
|
5.1 Micromoles per liter
Standard Deviation 4.18
|
2.9 Micromoles per liter
Standard Deviation 4.13
|
2.6 Micromoles per liter
Standard Deviation 2.07
|
-1.1 Micromoles per liter
Standard Deviation 2.02
|
-1.9 Micromoles per liter
Standard Deviation 4.18
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Bilirubin,Week 44,n=11,11,6,8,9
|
4.4 Micromoles per liter
Standard Deviation 6.14
|
1.8 Micromoles per liter
Standard Deviation 3.52
|
2.5 Micromoles per liter
Standard Deviation 2.17
|
-0.1 Micromoles per liter
Standard Deviation 2.03
|
-1.2 Micromoles per liter
Standard Deviation 3.23
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Bilirubin,Week 48,n=9,8,5,8,5
|
6.7 Micromoles per liter
Standard Deviation 6.22
|
3.8 Micromoles per liter
Standard Deviation 3.62
|
2.2 Micromoles per liter
Standard Deviation 1.79
|
-1.1 Micromoles per liter
Standard Deviation 1.96
|
-1.8 Micromoles per liter
Standard Deviation 2.49
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Bilirubin,Week 52,n=9,5,5,5,4
|
4.8 Micromoles per liter
Standard Deviation 5.09
|
1.6 Micromoles per liter
Standard Deviation 3.58
|
5.0 Micromoles per liter
Standard Deviation 4.36
|
-1.0 Micromoles per liter
Standard Deviation 2.00
|
1.8 Micromoles per liter
Standard Deviation 6.85
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Direct Bilirubin,Week 2,n=38,39,26,24,26
|
0.1 Micromoles per liter
Standard Deviation 1.03
|
-0.1 Micromoles per liter
Standard Deviation 0.92
|
0.1 Micromoles per liter
Standard Deviation 0.82
|
0.0 Micromoles per liter
Standard Deviation 0.59
|
-0.3 Micromoles per liter
Standard Deviation 0.75
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Direct Bilirubin,Week 4,n=37,38,25,23,27
|
0.3 Micromoles per liter
Standard Deviation 0.97
|
0.1 Micromoles per liter
Standard Deviation 0.73
|
0.1 Micromoles per liter
Standard Deviation 0.76
|
-0.2 Micromoles per liter
Standard Deviation 0.83
|
-0.6 Micromoles per liter
Standard Deviation 1.31
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Direct Bilirubin,Week 8,n=34,31,24,22,23
|
0.2 Micromoles per liter
Standard Deviation 1.01
|
0.1 Micromoles per liter
Standard Deviation 0.72
|
0.0 Micromoles per liter
Standard Deviation 0.29
|
-0.1 Micromoles per liter
Standard Deviation 0.75
|
-0.8 Micromoles per liter
Standard Deviation 1.31
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Direct Bilirubin,Week 12,n=32,28,24,22,21
|
0.3 Micromoles per liter
Standard Deviation 1.12
|
0.1 Micromoles per liter
Standard Deviation 0.66
|
0.2 Micromoles per liter
Standard Deviation 0.96
|
-0.1 Micromoles per liter
Standard Deviation 0.75
|
-0.6 Micromoles per liter
Standard Deviation 1.29
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Direct Bilirubin,Week 16,n=28,26,22,19,18
|
0.3 Micromoles per liter
Standard Deviation 1.19
|
0.4 Micromoles per liter
Standard Deviation 0.98
|
0.3 Micromoles per liter
Standard Deviation 0.63
|
-0.1 Micromoles per liter
Standard Deviation 0.46
|
-0.8 Micromoles per liter
Standard Deviation 1.40
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Direct Bilirubin,Week 20,n=25,23,19,18,16
|
1.4 Micromoles per liter
Standard Deviation 3.29
|
0.1 Micromoles per liter
Standard Deviation 1.12
|
0.4 Micromoles per liter
Standard Deviation 0.77
|
-0.2 Micromoles per liter
Standard Deviation 0.65
|
-0.9 Micromoles per liter
Standard Deviation 1.45
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Direct Bilirubin,Week 24,n=22,21,16,17,16
|
1.0 Micromoles per liter
Standard Deviation 1.59
|
0.0 Micromoles per liter
Standard Deviation 0.89
|
0.4 Micromoles per liter
Standard Deviation 0.81
|
-0.4 Micromoles per liter
Standard Deviation 0.79
|
-0.8 Micromoles per liter
Standard Deviation 1.24
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Direct Bilirubin,Week 28,n=19,18,12,13,14
|
0.7 Micromoles per liter
Standard Deviation 1.34
|
-0.1 Micromoles per liter
Standard Deviation 1.08
|
0.1 Micromoles per liter
Standard Deviation 0.90
|
-0.5 Micromoles per liter
Standard Deviation 0.88
|
-1.0 Micromoles per liter
Standard Deviation 1.52
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Direct Bilirubin,Week 32,n=19,15,10,12,13
|
0.5 Micromoles per liter
Standard Deviation 1.26
|
0.3 Micromoles per liter
Standard Deviation 1.03
|
0.1 Micromoles per liter
Standard Deviation 0.32
|
-0.2 Micromoles per liter
Standard Deviation 0.58
|
-1.2 Micromoles per liter
Standard Deviation 1.54
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Direct Bilirubin,Week 36,n=15,12,10,12,13
|
0.7 Micromoles per liter
Standard Deviation 1.22
|
0.3 Micromoles per liter
Standard Deviation 1.44
|
-0.1 Micromoles per liter
Standard Deviation 0.74
|
-0.2 Micromoles per liter
Standard Deviation 0.58
|
-1.2 Micromoles per liter
Standard Deviation 1.54
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Direct Bilirubin,Week 40,n=15,11,6,10,10
|
0.6 Micromoles per liter
Standard Deviation 1.18
|
-0.4 Micromoles per liter
Standard Deviation 0.81
|
-0.3 Micromoles per liter
Standard Deviation 0.71
|
0.0 Micromoles per liter
Standard Deviation 0.00
|
-1.4 Micromoles per liter
Standard Deviation 1.35
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Direct Bilirubin,Week 44,n=11,11,6,8,9
|
0.8 Micromoles per liter
Standard Deviation 0.98
|
-0.4 Micromoles per liter
Standard Deviation 0.81
|
0.2 Micromoles per liter
Standard Deviation 0.41
|
0.0 Micromoles per liter
Standard Deviation 0.00
|
-0.7 Micromoles per liter
Standard Deviation 1.00
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Direct Bilirubin,Week 48,n=9,8,5,8,5
|
1.2 Micromoles per liter
Standard Deviation 0.97
|
-0.3 Micromoles per liter
Standard Deviation 0.71
|
-0.6 Micromoles per liter
Standard Deviation 1.34
|
0.0 Micromoles per liter
Standard Deviation 0.00
|
-1.2 Micromoles per liter
Standard Deviation 1.10
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Direct Bilirubin,Week 52,n=9,5,5,5,4
|
1.0 Micromoles per liter
Standard Deviation 1.00
|
-0.8 Micromoles per liter
Standard Deviation 1.10
|
-0.2 Micromoles per liter
Standard Deviation 1.10
|
-0.4 Micromoles per liter
Standard Deviation 0.89
|
-0.5 Micromoles per liter
Standard Deviation 1.00
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Indirect Bilirubin,Week 2,n=38,39,26,24,26
|
1.7 Micromoles per liter
Standard Deviation 2.51
|
1.6 Micromoles per liter
Standard Deviation 2.84
|
1.8 Micromoles per liter
Standard Deviation 3.18
|
-1.1 Micromoles per liter
Standard Deviation 1.75
|
-0.7 Micromoles per liter
Standard Deviation 3.19
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Indirect Bilirubin,Week 4,n=37,38,25,23,27
|
2.1 Micromoles per liter
Standard Deviation 4.93
|
1.9 Micromoles per liter
Standard Deviation 2.86
|
1.8 Micromoles per liter
Standard Deviation 2.31
|
-1.6 Micromoles per liter
Standard Deviation 2.19
|
-0.9 Micromoles per liter
Standard Deviation 4.27
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Indirect Bilirubin,Week 8,n=34,31,24,22,23
|
2.8 Micromoles per liter
Standard Deviation 3.37
|
2.7 Micromoles per liter
Standard Deviation 4.37
|
0.9 Micromoles per liter
Standard Deviation 2.90
|
-2.2 Micromoles per liter
Standard Deviation 2.47
|
-2.4 Micromoles per liter
Standard Deviation 4.34
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Indirect Bilirubin,Week 12,n=32,28,24,22,21
|
4.0 Micromoles per liter
Standard Deviation 7.94
|
2.7 Micromoles per liter
Standard Deviation 3.28
|
2.5 Micromoles per liter
Standard Deviation 2.87
|
-1.0 Micromoles per liter
Standard Deviation 2.63
|
-2.3 Micromoles per liter
Standard Deviation 3.79
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Indirect Bilirubin,Week 16,n=28,26,22,19,18
|
2.4 Micromoles per liter
Standard Deviation 4.29
|
4.0 Micromoles per liter
Standard Deviation 3.88
|
3.6 Micromoles per liter
Standard Deviation 3.22
|
-0.8 Micromoles per liter
Standard Deviation 1.84
|
-2.5 Micromoles per liter
Standard Deviation 3.00
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Indirect Bilirubin,Week 20,n=25,23,19,18,16
|
3.3 Micromoles per liter
Standard Deviation 6.22
|
4.2 Micromoles per liter
Standard Deviation 3.66
|
3.2 Micromoles per liter
Standard Deviation 3.21
|
-1.2 Micromoles per liter
Standard Deviation 2.23
|
-2.2 Micromoles per liter
Standard Deviation 3.47
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Indirect Bilirubin,Week 24,n=22,21,16,17,16
|
4.0 Micromoles per liter
Standard Deviation 5.52
|
3.0 Micromoles per liter
Standard Deviation 3.88
|
4.4 Micromoles per liter
Standard Deviation 3.03
|
-0.8 Micromoles per liter
Standard Deviation 1.64
|
-0.9 Micromoles per liter
Standard Deviation 2.62
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Indirect Bilirubin,Week 28,n=19,18,12,13,14
|
3.7 Micromoles per liter
Standard Deviation 5.05
|
3.8 Micromoles per liter
Standard Deviation 3.42
|
3.0 Micromoles per liter
Standard Deviation 3.02
|
-0.3 Micromoles per liter
Standard Deviation 1.80
|
-2.2 Micromoles per liter
Standard Deviation 2.55
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Indirect Bilirubin,Week 32,n=19,15,10,12,13
|
3.7 Micromoles per liter
Standard Deviation 4.24
|
3.7 Micromoles per liter
Standard Deviation 3.77
|
2.6 Micromoles per liter
Standard Deviation 2.99
|
-0.6 Micromoles per liter
Standard Deviation 2.35
|
-1.8 Micromoles per liter
Standard Deviation 2.52
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Indirect Bilirubin,Week 36,n=15,12,10,12,13
|
4.5 Micromoles per liter
Standard Deviation 4.02
|
5.0 Micromoles per liter
Standard Deviation 4.47
|
2.4 Micromoles per liter
Standard Deviation 2.63
|
-0.8 Micromoles per liter
Standard Deviation 1.66
|
-0.8 Micromoles per liter
Standard Deviation 3.83
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Indirect Bilirubin,Week 40,n=15,11,6,10,10
|
4.5 Micromoles per liter
Standard Deviation 3.94
|
3.3 Micromoles per liter
Standard Deviation 3.61
|
2.9 Micromoles per liter
Standard Deviation 2.03
|
-1.1 Micromoles per liter
Standard Deviation 2.02
|
-0.5 Micromoles per liter
Standard Deviation 2.95
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Indirect Bilirubin,Week 44,n=11,11,6,8,9
|
3.5 Micromoles per liter
Standard Deviation 5.43
|
2.2 Micromoles per liter
Standard Deviation 3.03
|
2.3 Micromoles per liter
Standard Deviation 2.34
|
-0.1 Micromoles per liter
Standard Deviation 2.03
|
-0.6 Micromoles per liter
Standard Deviation 2.88
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Indirect Bilirubin,Week 48,n=9,8,5,8,5
|
5.4 Micromoles per liter
Standard Deviation 5.68
|
4.0 Micromoles per liter
Standard Deviation 3.21
|
2.8 Micromoles per liter
Standard Deviation 2.28
|
-1.1 Micromoles per liter
Standard Deviation 1.96
|
-0.6 Micromoles per liter
Standard Deviation 2.19
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Indirect Bilirubin,Week 52,n=9,5,5,5,4
|
3.8 Micromoles per liter
Standard Deviation 4.52
|
2.4 Micromoles per liter
Standard Deviation 2.61
|
5.2 Micromoles per liter
Standard Deviation 5.02
|
-0.6 Micromoles per liter
Standard Deviation 1.95
|
2.3 Micromoles per liter
Standard Deviation 6.13
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Creatinine,Week 2,n=38,39,26,24,26
|
4.96 Micromoles per liter
Standard Deviation 9.319
|
4.10 Micromoles per liter
Standard Deviation 12.030
|
0.71 Micromoles per liter
Standard Deviation 5.170
|
-1.65 Micromoles per liter
Standard Deviation 6.165
|
0.28 Micromoles per liter
Standard Deviation 7.485
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Creatinine,,Week 4,n=37,38,25,23,27
|
4.00 Micromoles per liter
Standard Deviation 11.061
|
3.03 Micromoles per liter
Standard Deviation 12.685
|
2.56 Micromoles per liter
Standard Deviation 6.760
|
-0.64 Micromoles per liter
Standard Deviation 5.781
|
0.48 Micromoles per liter
Standard Deviation 7.222
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Creatinine,Week 8,n=34,31,24,22,23
|
3.26 Micromoles per liter
Standard Deviation 10.522
|
1.48 Micromoles per liter
Standard Deviation 14.285
|
0.95 Micromoles per liter
Standard Deviation 6.027
|
-2.93 Micromoles per liter
Standard Deviation 7.703
|
2.43 Micromoles per liter
Standard Deviation 8.688
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Creatinine,,Week 12,n=32,28,24,22,21
|
2.88 Micromoles per liter
Standard Deviation 11.590
|
-0.84 Micromoles per liter
Standard Deviation 16.780
|
3.28 Micromoles per liter
Standard Deviation 6.334
|
-3.09 Micromoles per liter
Standard Deviation 7.615
|
1.46 Micromoles per liter
Standard Deviation 6.093
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Creatinine,,Week 16,n=28,26,22,19,18
|
3.87 Micromoles per liter
Standard Deviation 9.387
|
1.16 Micromoles per liter
Standard Deviation 12.971
|
1.27 Micromoles per liter
Standard Deviation 6.604
|
-0.14 Micromoles per liter
Standard Deviation 9.654
|
3.37 Micromoles per liter
Standard Deviation 15.068
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Creatinine,,Week 20,n=25,23,19,18,16
|
-0.87 Micromoles per liter
Standard Deviation 8.652
|
0.33 Micromoles per liter
Standard Deviation 9.278
|
-0.09 Micromoles per liter
Standard Deviation 5.721
|
-0.18 Micromoles per liter
Standard Deviation 6.991
|
4.73 Micromoles per liter
Standard Deviation 12.179
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Creatinine,Week 24,n=22,21,16,17,16
|
1.58 Micromoles per liter
Standard Deviation 9.671
|
-0.45 Micromoles per liter
Standard Deviation 20.542
|
1.86 Micromoles per liter
Standard Deviation 9.364
|
-1.14 Micromoles per liter
Standard Deviation 8.093
|
2.63 Micromoles per liter
Standard Deviation 7.834
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Creatinine,,Week 28,n=19,18,12,13,14
|
5.00 Micromoles per liter
Standard Deviation 12.803
|
0.46 Micromoles per liter
Standard Deviation 17.574
|
-1.33 Micromoles per liter
Standard Deviation 5.372
|
-0.28 Micromoles per liter
Standard Deviation 4.970
|
4.07 Micromoles per liter
Standard Deviation 7.431
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Creatinine, Week 32,n=19,15,10,12,13
|
3.88 Micromoles per liter
Standard Deviation 11.182
|
-2.52 Micromoles per liter
Standard Deviation 20.459
|
-1.33 Micromoles per liter
Standard Deviation 7.598
|
0.59 Micromoles per liter
Standard Deviation 7.911
|
4.10 Micromoles per liter
Standard Deviation 7.264
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Creatinine,,Week 36,n=15,12,10,12,13
|
1.09 Micromoles per liter
Standard Deviation 11.330
|
-3.82 Micromoles per liter
Standard Deviation 22.270
|
0.88 Micromoles per liter
Standard Deviation 7.151
|
4.56 Micromoles per liter
Standard Deviation 9.011
|
3.62 Micromoles per liter
Standard Deviation 11.433
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Creatinine,,Week 40,n=15,11,6,10,10
|
4.87 Micromoles per liter
Standard Deviation 11.617
|
-1.45 Micromoles per liter
Standard Deviation 10.674
|
-0.88 Micromoles per liter
Standard Deviation 9.831
|
1.67 Micromoles per liter
Standard Deviation 9.527
|
1.55 Micromoles per liter
Standard Deviation 10.630
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Creatinine, Week 44,n=11,11,6,8,9
|
0.03 Micromoles per liter
Standard Deviation 14.182
|
-7.06 Micromoles per liter
Standard Deviation 19.793
|
-2.38 Micromoles per liter
Standard Deviation 7.847
|
0.23 Micromoles per liter
Standard Deviation 7.876
|
3.96 Micromoles per liter
Standard Deviation 14.656
|
|
Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin
Creatinine,,Week 48,n=9,8,5,8,5
|
7.21 Micromoles per liter
Standard Deviation 14.144
|
-7.15 Micromoles per liter
Standard Deviation 26.680
|
2.80 Micromoles per liter
Standard Deviation 8.917
|
1.43 Micromoles per liter
Standard Deviation 5.646
|
5.72 Micromoles per liter
Standard Deviation 18.804
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 44 and 52Population: Safety Population. Data was not collected due to early termination of the study
Blood samples for Pharmacokinetic analysis of sirukumab serum concentrations were planned to be collected at specified time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Week 0) and up to 52 weeksPopulation: Safety Population. Data was not collected due to early termination of the study
Blood samples for Pharmacokinetic analysis of Serum anti-sirukumab antibodies were planned to be collected at specified time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Week 0) and up to 52 weeksPopulation: Safety Population. Data was not collected due to early termination of the study
Blood samples for Pharmacodynamic analysis were planned but not collected due to early termination of study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 120 weeksPopulation: Safety-Part B Population included all randomized participants who received at least 1 dose of SC IP in Part A and entered Part B
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs for part B have been reported.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
All AEs
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
All SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Corticosteroid related AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 120 weeksPopulation: Safety-Part B Population
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs for part B have been reported.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=3 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B
All AEs
|
4 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B
All SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B
Corticosteroid related AEs
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
DBP,Week 8,n=2,1,1,2,1
|
3.0 Millimeters of mercury
Standard Deviation 4.24
|
-5.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-4.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
4.0 Millimeters of mercury
Standard Deviation 2.83
|
-1.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
DBP,Week 24,n=2,0,0,0,0
|
1.0 Millimeters of mercury
Standard Deviation 1.41
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
DBP,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
7.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
DBP,Week 16,n=2,0,0,1,0
|
-5.0 Millimeters of mercury
Standard Deviation 7.07
|
—
|
—
|
15.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
DBP,Week 36,n=2,0,0,0,0
|
-2.0 Millimeters of mercury
Standard Deviation 2.83
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
DBP,Week 38,n=1,0,0,0,0
|
-8.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
DBP,Week 40,n=1,0,0,0,0
|
-10.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
DBP,Week follow up,n=2,1,0,1,1
|
-2.0 Millimeters of mercury
Standard Deviation 5.66
|
-7.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
21.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
3.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
SBP,Week 2,n=1,1,0,1,2
|
2.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
15.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
0.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
6.5 Millimeters of mercury
Standard Deviation 19.09
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
SBP,Week 4,n=2,1,1,2,2
|
5.0 Millimeters of mercury
Standard Deviation 21.21
|
0.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
6.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.5 Millimeters of mercury
Standard Deviation 3.54
|
1.5 Millimeters of mercury
Standard Deviation 0.71
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
SBP,Week 8,n=2,1,1,2,1
|
14.0 Millimeters of mercury
Standard Deviation 8.49
|
18.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-12.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-11.5 Millimeters of mercury
Standard Deviation 10.61
|
5.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
SBP,Week 12,n=2,1,1,1,0
|
7.0 Millimeters of mercury
Standard Deviation 1.41
|
14.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
8.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
SBP,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
9.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
SBP,Week 16,n=2,0,0,1,0
|
0.0 Millimeters of mercury
Standard Deviation 0.00
|
—
|
—
|
11.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
SBP,Week 24,n=2,0,0,0,0
|
8.0 Millimeters of mercury
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
SBP,Week 36,n=2,0,0,0,0
|
11.0 Millimeters of mercury
Standard Deviation 9.90
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
SBP,Week 38,n=1,0,0,0,0
|
-6.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
SBP,Week 40,n=1,0,0,0,0
|
-10.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
SBP,Week follow up,n=2,1,0,1,1
|
3.0 Millimeters of mercury
Standard Deviation 18.38
|
-1.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
22.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
12.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
DBP,Week 2,n=1,1,0,1,2
|
-10.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-8.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
0.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
7.0 Millimeters of mercury
Standard Deviation 9.90
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
DBP,Week 4,n=2,1,1,2,2
|
-3.0 Millimeters of mercury
Standard Deviation 12.73
|
-15.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
6.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 Millimeters of mercury
Standard Deviation 5.66
|
4.5 Millimeters of mercury
Standard Deviation 3.54
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
DBP,Week 12,n=2,1,1,1,0
|
-5.0 Millimeters of mercury
Standard Deviation 7.07
|
-5.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
4.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=3 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
SBP,Week 4,n=3,3,3,1,2
|
-23.7 Millimeters of mercury
Standard Deviation 4.73
|
-6.3 Millimeters of mercury
Standard Deviation 5.51
|
7.0 Millimeters of mercury
Standard Deviation 25.36
|
10.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.0 Millimeters of mercury
Standard Deviation 8.49
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
SBP,Week 8,n=2,1,2,0,2
|
-32.5 Millimeters of mercury
Standard Deviation 14.85
|
-6.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-7.5 Millimeters of mercury
Standard Deviation 17.68
|
—
|
-1.5 Millimeters of mercury
Standard Deviation 0.71
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
SBP,Week 12,n=1,1,1,1,1
|
-59.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-4.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
15.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
13.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
SBP,Week 16,n=0,1,1,1,0
|
—
|
-8.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
25.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-8.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
SBP,Week 24,n=0,1,0,0,0
|
—
|
4.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
SBP,Week 36,n=0,1,0,0,0
|
—
|
-26.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
SBP,Week follow up,n=5,4,2,3,2
|
-7.4 Millimeters of mercury
Standard Deviation 19.62
|
-3.3 Millimeters of mercury
Standard Deviation 8.54
|
-17.5 Millimeters of mercury
Standard Deviation 31.82
|
10.7 Millimeters of mercury
Standard Deviation 10.07
|
5.0 Millimeters of mercury
Standard Deviation 1.41
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
DBP,Week 4,n=3,3,3,1,2
|
-8.3 Millimeters of mercury
Standard Deviation 14.29
|
0.3 Millimeters of mercury
Standard Deviation 4.51
|
7.7 Millimeters of mercury
Standard Deviation 8.74
|
-4.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis.
|
-11.0 Millimeters of mercury
Standard Deviation 11.31
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
DBP,Week 8,n=2,1,2,0,2
|
-9.0 Millimeters of mercury
Standard Deviation 2.83
|
-10.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis.
|
16.5 Millimeters of mercury
Standard Deviation 2.12
|
—
|
-6.0 Millimeters of mercury
Standard Deviation 8.49
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
DBP,Week 12,n=1,1,1,1,1
|
-22.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis.
|
-6.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis.
|
15.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis.
|
8.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis.
|
-9.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis.
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
DBP,Week 16,n=0,1,1,1,0
|
—
|
0.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis.
|
15.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis.
|
-17.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis.
|
—
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
DBP,Week 24,n=0,1,0,0,0
|
—
|
-10.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis.
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
DBP,Week 36,n=0,1,0,0,0
|
—
|
-10.0 Millimeters of mercury
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis.
|
—
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
DBP,Week follow up,n=5,4,2,3,2
|
3.4 Millimeters of mercury
Standard Deviation 12.34
|
-2.8 Millimeters of mercury
Standard Deviation 4.57
|
12.5 Millimeters of mercury
Standard Deviation 10.61
|
6.0 Millimeters of mercury
Standard Deviation 4.36
|
-2.0 Millimeters of mercury
Standard Deviation 4.24
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 8,n=2,1,1,2,1
|
0.0 beats per minute
Standard Deviation 5.66
|
3.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
4.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-12.5 beats per minute
Standard Deviation 9.19
|
-4.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 2,n=1,1,0,1,2
|
4.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
7.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
0.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
4.0 beats per minute
Standard Deviation 8.49
|
|
Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 4,n=2,1,1,2,2
|
-2.0 beats per minute
Standard Deviation 8.49
|
6.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-10.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-17.0 beats per minute
Standard Deviation 2.83
|
-5.5 beats per minute
Standard Deviation 9.19
|
|
Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 12,n=2,1,1,1,0
|
-2.0 beats per minute
Standard Deviation 2.83
|
2.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis.
|
4.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis.
|
-12.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis.
|
—
|
|
Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
-24.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis.
|
—
|
|
Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 16,n=2,0,0,1,0
|
2.0 beats per minute
Standard Deviation 2.83
|
—
|
—
|
-14.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis.
|
—
|
|
Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 24,n=2,0,0,0,0
|
5.0 beats per minute
Standard Deviation 1.41
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 36,n=2,0,0,0,0
|
-2.0 beats per minute
Standard Deviation 8.49
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 38,n=1,0,0,0,0
|
0.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis.
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 40,n=1,0,0,0,0
|
0.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week follow up,n=2,1,0,1,1
|
5.0 beats per minute
Standard Deviation 12.73
|
-3.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
-22.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
6.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab is presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=3 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 4,n=3,3,3,1,2
|
3.7 beats per minute
Standard Deviation 1.53
|
0.3 beats per minute
Standard Deviation 3.51
|
-14.7 beats per minute
Standard Deviation 2.31
|
-29.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.5 beats per minute
Standard Deviation 6.36
|
|
Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 8,n=2,1,2,0,2
|
8.0 beats per minute
Standard Deviation 4.24
|
4.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-5.5 beats per minute
Standard Deviation 2.12
|
—
|
-0.5 beats per minute
Standard Deviation 0.71
|
|
Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 12,n=1,1,1,1,1
|
11.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-4.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
4.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
6.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
6.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 16,n=0,1,1,1,0
|
—
|
-4.0 beats per minute
|
-4.0 beats per minute
|
6.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 24,n=0,1,0,0,0
|
—
|
0.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 36,n=0,1,0,0,0
|
—
|
0.0 beats per minute
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week follow up,n=5,4,2,3,2
|
1.4 beats per minute
Standard Deviation 10.11
|
4.0 beats per minute
Standard Deviation 6.53
|
-1.5 beats per minute
Standard Deviation 2.12
|
-7.7 beats per minute
Standard Deviation 17.62
|
7.5 beats per minute
Standard Deviation 4.95
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 2,n=1,1,0,1,2
|
0.20 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.50 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
-0.40 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.65 Celsius
Standard Deviation 0.071
|
|
Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 4,n=2,1,1,2,2
|
0.15 Celsius
Standard Deviation 0.071
|
-0.50 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.30 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.10 Celsius
Standard Deviation 0.141
|
0.30 Celsius
Standard Deviation 1.414
|
|
Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 8,n=2,1,1,2,1
|
-0.15 Celsius
Standard Deviation 0.212
|
0.00 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.10 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.20 Celsius
Standard Deviation 0.000
|
-0.50 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 12,n=2,1,1,1,0
|
-0.25 Celsius
Standard Deviation 0.071
|
0.90 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.50 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.00 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
-0.20 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 16,n=2,0,0,1,0
|
-0.05 Celsius
Standard Deviation 0.071
|
—
|
—
|
-0.10 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 24,n=2,0,0,0,0
|
-0.42 Celsius
Standard Deviation 0.163
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 36,n=2,0,0,0,0
|
-0.25 Celsius
Standard Deviation 0.071
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 38,n=1,0,0,0,0
|
0.00 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 40,n=1,0,0,0,0
|
0.00 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week follow up,n=2,1,0,1,1
|
0.15 Celsius
Standard Deviation 0.071
|
0.00 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
0.50 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.60 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=3 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 4,n=3,3,3,1,2
|
0.10 Celsius
Standard Deviation 0.458
|
0.07 Celsius
Standard Deviation 0.115
|
0.00 Celsius
Standard Deviation 0.300
|
-0.20 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.10 Celsius
Standard Deviation 0.283
|
|
Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 8,n=2,1,2,0,2
|
-0.10 Celsius
Standard Deviation 0.566
|
0.00 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.10 Celsius
Standard Deviation 0.283
|
—
|
0.05 Celsius
Standard Deviation 0.354
|
|
Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 12,n=1,1,1,1,1
|
-0.30 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.40 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.00 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.00 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.50 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 16,n=0,1,1,1,0
|
—
|
0.20 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.00 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.10 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 24,n=0,1,0,0,0
|
—
|
0.00 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 36,n=0,1,0,0,0
|
—
|
0.00 Celsius
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week follow up,n=5,4,2,3,2
|
0.06 Celsius
Standard Deviation 0.305
|
0.15 Celsius
Standard Deviation 0.265
|
0.00 Celsius
Standard Deviation 0.283
|
-0.13 Celsius
Standard Deviation 0.252
|
0.20 Celsius
Standard Deviation 0.283
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Eosinophils,Week 2,n=1,1,0,1,2
|
-0.010 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.110 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
0.000 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.010 Giga cells per liter
Standard Deviation 0.0141
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Eosinophils,Week 4,n=2,1,1,2,2
|
-0.015 Giga cells per liter
Standard Deviation 0.0212
|
-0.210 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.010 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.030 Giga cells per liter
Standard Deviation 0.0283
|
0.035 Giga cells per liter
Standard Deviation 0.0495
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Eosinophils,Week 8,n=2,1,1,2,1
|
-0.010 Giga cells per liter
Standard Deviation 0.0424
|
-0.180 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.040 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.120 Giga cells per liter
Standard Deviation 0.1838
|
0.045 Giga cells per liter
Standard Deviation 0.0636
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Eosinophils,Week 12,n=2,0,1,1,0
|
-0.030 Giga cells per liter
Standard Deviation 0.0000
|
—
|
0.030 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.160 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Eosinophils,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
-0.290 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Eosinophils,Week 16,n=2,0,0,1,0
|
0.030 Giga cells per liter
Standard Deviation 0.0141
|
—
|
—
|
-0.270 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Eosinophils,Week 24,n=2,0,0,0,0
|
-0.015 Giga cells per liter
Standard Deviation 0.0212
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Eosinophils,Week 36,n=2,0,0,0,0
|
-0.010 Giga cells per liter
Standard Deviation 0.0566
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Eosinophils,Week 38,n=1,0,0,0,0
|
0.020 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Eosinophils,Week 40,n=1,0,0,0,0
|
-0.030 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Leukocytes,Week 2,n=1,1,0,1,2
|
-0.20 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.30 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
2.60 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.30 Giga cells per liter
Standard Deviation 0.424
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Leukocytes,Week 4,n=2,1,1,2,2
|
0.25 Giga cells per liter
Standard Deviation 0.778
|
-0.30 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.20 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.60 Giga cells per liter
Standard Deviation 1.697
|
-1.45 Giga cells per liter
Standard Deviation 0.071
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Leukocytes,Week 8,n=2,1,1,2,1
|
-0.25 Giga cells per liter
Standard Deviation 1.061
|
0.00 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.60 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.10 Giga cells per liter
Standard Deviation 0.000
|
-0.95 Giga cells per liter
Standard Deviation 2.333
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Leukocytes,Week 12,n=2,0,1,1,0
|
-0.10 Giga cells per liter
Standard Deviation 0.990
|
—
|
0.90 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.60 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Leukocytes,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
0.40 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Leukocytes,Week 16,n=2,0,0,1,0
|
-0.45 Giga cells per liter
Standard Deviation 0.778
|
—
|
—
|
-0.30 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Leukocytes,Week 24,n=2,0,0,0,0
|
-0.20 Giga cells per liter
Standard Deviation 0.424
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Leukocytes,Week 36,n=2,0,0,0,0
|
0.65 Giga cells per liter
Standard Deviation 0.354
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Leukocytes,Week 38,n=1,0,0,0,0
|
-0.50 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Leukocytes,Week 40,n=1,0,0,0,0
|
-1.30 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Lymphocytes,Week 2,n=1,1,0,1,2
|
-0.170 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.000 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
-0.400 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.160 Giga cells per liter
Standard Deviation 0.0990
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Lymphocytes,Week 4,n=2,1,1,2,2
|
0.110 Giga cells per liter
Standard Deviation 0.0566
|
-0.340 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.010 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.035 Giga cells per liter
Standard Deviation 0.2051
|
-0.115 Giga cells per liter
Standard Deviation 0.5162
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Lymphocytes,Week 8,n=2,1,1,2,1
|
-0.120 Giga cells per liter
Standard Deviation 0.0283
|
0.160 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.050 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.185 Giga cells per liter
Standard Deviation 0.3323
|
-0.275 Giga cells per liter
Standard Deviation 0.4172
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Lymphocytes,Week 12,n=2,0,1,1,0
|
-0.030 Giga cells per liter
Standard Deviation 0.0283
|
—
|
0.300 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.190 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Lymphocytes,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
0.490 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Lymphocytes,Week 16,n=2,0,0,1,0
|
-0.230 Giga cells per liter
Standard Deviation 0.2828
|
—
|
—
|
0.540 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Lymphocytes,Week 24,n=2,0,0,0,0
|
-0.320 Giga cells per liter
Standard Deviation 0.1697
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Lymphocytes,Week 36,n=2,0,0,0,0
|
0.195 Giga cells per liter
Standard Deviation 0.1768
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
LymphocytesWeek 38,n=1,0,0,0,0
|
0.010 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Lymphocytes,Week 40,n=1,0,0,0,0
|
-0.160 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Neutrophils ,Week 2,n=1,1,0,1,2
|
-0.040 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.510 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
3.010 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.210 Giga cells per liter
Standard Deviation 0.5233
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Neutrophils ,Week 4,n=2,1,1,2,2
|
0.205 Giga cells per liter
Standard Deviation 0.5728
|
0.400 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.230 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.740 Giga cells per liter
Standard Deviation 1.8950
|
-1.420 Giga cells per liter
Standard Deviation 0.4950
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Neutrophils ,Week 8,n=2,1,1,2,2
|
-0.265 Giga cells per liter
Standard Deviation 0.6435
|
0.060 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.620 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.485 Giga cells per liter
Standard Deviation 0.1909
|
-0.790 Giga cells per liter
Standard Deviation 1.8385
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Neutrophils ,Week 12,n=2,0,1,1,0
|
0.020 Giga cells per liter
Standard Deviation 0.8061
|
—
|
0.630 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.320 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Neutrophils ,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
0.590 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Neutrophils ,Week 16,n=2,0,0,1,0
|
-0.235 Giga cells per liter
Standard Deviation 0.4879
|
—
|
—
|
-0.050 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Neutrophils ,Week 24,n=2,0,0,0,0
|
0.085 Giga cells per liter
Standard Deviation 0.6859
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Neutrophils ,Week 36,n=2,0,0,0,0
|
0.540 Giga cells per liter
Standard Deviation 0.6788
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Neutrophils ,Week 38,n=1,0,0,0,0
|
-0.460 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Neutrophils,Week 40,n=1,0,0,0,0
|
-0.770 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Platelets ,Week 2,n=1,1,0,1,2
|
5.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
4.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
-27.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-20.5 Giga cells per liter
Standard Deviation 57.28
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Platelets,Week 4,n=2,1,1,2,2
|
-1.0 Giga cells per liter
Standard Deviation 4.24
|
6.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-33.5 Giga cells per liter
Standard Deviation 30.41
|
-42.0 Giga cells per liter
Standard Deviation 11.31
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Platelets,Week 8,n=2,1,1,2,1
|
7.0 Giga cells per liter
Standard Deviation 11.31
|
-6.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-20.5 Giga cells per liter
Standard Deviation 28.99
|
-40.0 Giga cells per liter
Standard Deviation 0.00
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Platelets,Week 12,n=2,0,1,1,0
|
7.0 Giga cells per liter
Standard Deviation 7.07
|
—
|
52.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
12.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Platelets,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
-31.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Platelets,Week 16,n=2,0,0,1,0
|
2.0 Giga cells per liter
Standard Deviation 1.41
|
—
|
—
|
-97.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Platelets,Week 24,n=2,0,0,0,0
|
-18.5 Giga cells per liter
Standard Deviation 9.19
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Platelets,Week 36,n=2,0,0,0,0
|
10.0 Giga cells per liter
Standard Deviation 21.21
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Platelets,Week 38,n=1,0,0,0,0
|
-15.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Platelets,Week 40,n=1,0,0,0,0
|
-6.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=3 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Leukocytes,Week 4,n=3,3,2,1,2
|
0.40 Giga cells per liter
Standard Deviation 0.500
|
0.30 Giga cells per liter
Standard Deviation 1.229
|
0.50 Giga cells per liter
Standard Deviation 0.000
|
-0.40 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.30 Giga cells per liter
Standard Deviation 0.990
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Lymphocytes,Week 16,n=0,1,1,1,0
|
—
|
-0.040 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.340 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.520 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Lymphocytes,Week 24,n=0,1,0,0,0
|
—
|
0.000 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Lymphocytes,Week 36,n=0,1,0,0,0
|
—
|
-0.240 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Neutrophils ,Week 4,n=3,3,2,1,2
|
0.183 Giga cells per liter
Standard Deviation 0.4196
|
0.333 Giga cells per liter
Standard Deviation 1.0108
|
0.180 Giga cells per liter
Standard Deviation 0.1414
|
0.390 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.815 Giga cells per liter
Standard Deviation 0.0212
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Eosinophils,Week 4,n=3,3,2,1,2
|
-0.110 Giga cells per liter
Standard Deviation 0.1735
|
-0.013 Giga cells per liter
Standard Deviation 0.0551
|
-0.050 Giga cells per liter
Standard Deviation 0.0849
|
-0.030 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.415 Giga cells per liter
Standard Deviation 0.5869
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Eosinophils,Week 8,n=2,1,2,0,2
|
-0.070 Giga cells per liter
Standard Deviation 0.0707
|
0.020 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.020 Giga cells per liter
Standard Deviation 0.2546
|
—
|
0.330 Giga cells per liter
Standard Deviation 0.4101
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Eosinophils,Week 12,n=1,1,1,1,1
|
-0.120 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.120 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.190 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.070 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.030 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Eosinophils,Week 16,n=0,1,1,1,0
|
—
|
-0.200 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.180 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.050 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Eosinophils,Week 24,n=0,1,0,0,0
|
—
|
-0.100 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Eosinophils,Week 36,n=0,1,0,0,0
|
—
|
-0.240 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Leukocytes,Week 8,n=2,1,2,0,2
|
0.25 Giga cells per liter
Standard Deviation 0.071
|
0.10 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.90 Giga cells per liter
Standard Deviation 0.424
|
—
|
0.65 Giga cells per liter
Standard Deviation 0.071
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Leukocytes,Week 12,n=1,1,1,1,1
|
-1.30 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.60 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.80 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.50 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.70 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Leukocytes,Week 16,n=0,1,1,1,0
|
—
|
-0.50 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.30 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.30 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Leukocytes,Week 24,n=0,1,0,0,0
|
—
|
-0.60 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Leukocytes,Week 36,n=0,1,0,0,0
|
—
|
-1.10 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Lymphocytes,Week 4,n=3,3,2,1,2
|
0.293 Giga cells per liter
Standard Deviation 0.2136
|
0.077 Giga cells per liter
Standard Deviation 0.2442
|
0.370 Giga cells per liter
Standard Deviation 0.0990
|
-0.960 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.015 Giga cells per liter
Standard Deviation 0.2475
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Lymphocytes,Week 8,n=2,1,2,0,2
|
0.470 Giga cells per liter
Standard Deviation 0.0707
|
0.090 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.205 Giga cells per liter
Standard Deviation 0.0495
|
—
|
-0.180 Giga cells per liter
Standard Deviation 0.4243
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Lymphocytes,Week 12,n=1,1,1,1,1
|
-0.210 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.140 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.190 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.380 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.610 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Neutrophils ,Week 8,n=2,1,2,0,2
|
-0.205 Giga cells per liter
Standard Deviation 0.1909
|
0.010 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.600 Giga cells per liter
Standard Deviation 0.0283
|
—
|
0.500 Giga cells per liter
Standard Deviation 0.8627
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Neutrophils ,Week 12,n=1,1,1,1,1
|
-0.750 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.440 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.820 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.770 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.140 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Neutrophils ,Week 16,n=0,1,1,1,0
|
—
|
-0.220 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.230 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.210 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Neutrophils ,Week 24,n=0,1,0,0,0
|
—
|
-0.350 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Neutrophils ,Week 36,n=0,1,0,0,0
|
—
|
-0.420 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Platelets,Week 4,n=3,3,2,1,2
|
15.0 Giga cells per liter
Standard Deviation 31.43
|
-6.0 Giga cells per liter
Standard Deviation 9.64
|
10.5 Giga cells per liter
Standard Deviation 3.54
|
26.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-14.0 Giga cells per liter
Standard Deviation 4.24
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Platelets,Week 8,n=2,1,2,0,2
|
17.5 Giga cells per liter
Standard Deviation 23.33
|
-25.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
10.0 Giga cells per liter
Standard Deviation 22.63
|
—
|
31.5 Giga cells per liter
Standard Deviation 4.95
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Platelets,Week 12,n=1,1,1,1,1
|
27.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-20.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
14.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-8.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
14.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Platelets,Week 16,n=0,1,1,1,0
|
—
|
-4.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
15.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-19.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Platelets,Week 24,n=0,1,0,0,0
|
—
|
-20.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Platelets,Week 36,n=0,1,0,0,0
|
—
|
-16.0 Giga cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
MCHC,Week 2,n=1,1,0,1,1
|
-3.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
-3.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
20.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
MCHC,Week 4,n=2,1,0,2,1
|
-1.5 Grams per liter
Standard Deviation 3.54
|
1.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
3.5 Grams per liter
Standard Deviation 2.12
|
23.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
MCHC,Week 8,n=2,1,0,2,1
|
0.0 Grams per liter
Standard Deviation 12.73
|
16.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
3.5 Grams per liter
Standard Deviation 14.85
|
9.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
MCHC,Week 12,n=2,0,0,1,0
|
-5.5 Grams per liter
Standard Deviation 0.71
|
—
|
—
|
19.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
MCHC,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
5.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
MCHC,Week 16,n=2,0,0,1,0
|
0.0 Grams per liter
Standard Deviation 1.41
|
—
|
—
|
11.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
MCHC,Week 24,n=2,0,0,0,0
|
-3.0 Grams per liter
Standard Deviation 2.83
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
MCHC,Week 36,n=2,0,0,0,0
|
-4.0 Grams per liter
Standard Deviation 4.24
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
MCHC,Week 38,n=1,0,0,0,0
|
-3.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
MCHC,Week 40,n=1,0,0,0,0
|
4.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Hemoglobin,Week 2,n=1,1,0,1,2
|
-4.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
7.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
10.0 Grams per liter
Standard Deviation 4.24
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Hemoglobin,Week 4,n=2,1,1,2,2
|
0.5 Grams per liter
Standard Deviation 0.71
|
-2.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-9.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.5 Grams per liter
Standard Deviation 10.61
|
8.0 Grams per liter
Standard Deviation 8.49
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Hemoglobin,Week 8,n=2,1,1,2,1
|
4.0 Grams per liter
Standard Deviation 1.41
|
3.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.5 Grams per liter
Standard Deviation 10.61
|
9.0 Grams per liter
Standard Deviation 4.24
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Hemoglobin,Week 12,n=2,0,1,1,0
|
1.5 Grams per liter
Standard Deviation 3.54
|
—
|
0.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-6.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Hemoglobin,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
0.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Hemoglobin,Week 16,n=2,0,0,1,0
|
0.0 Grams per liter
Standard Deviation 0.00
|
—
|
—
|
8.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Hemoglobin,Week 24,n=2,0,0,0,0
|
-0.5 Grams per liter
Standard Deviation 7.78
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Hemoglobin,Week 36,n=2,0,0,0,0
|
-1.5 Grams per liter
Standard Deviation 3.54
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Hemoglobin,Week 38,n=1,0,0,0,0
|
-3.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Hemoglobin,Week 40,n=1,0,0,0,0
|
-3.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=3 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
MCHC,Week 4,n=3,3,2,1,2
|
-18.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-14.0 Grams per liter
Standard Deviation 4.24
|
-3.0 Grams per liter
Standard Deviation 1.41
|
0.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-7.0 Grams per liter
Standard Deviation 11.31
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
MCHC,Week 8,n=0,1,2,0,2
|
—
|
-8.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.5 Grams per liter
Standard Deviation 16.26
|
—
|
8.0 Grams per liter
Standard Deviation 19.80
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
MCHC,Week 12,n=0,1,1,1,1
|
—
|
-10.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
11.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
21.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
11.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
MCHC,Week 16,n=0,1,1,1,0
|
—
|
-9.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
8.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
MCHC,Week 24,n=0,1,0,0,0
|
—
|
-17.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
MCHC,Week 36,n=0,1,0,0,0
|
—
|
-15.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Hemoglobin,Week 4,n=3,3,2,1,2
|
-4.0 Grams per liter
Standard Deviation 5.29
|
-6.3 Grams per liter
Standard Deviation 3.51
|
2.0 Grams per liter
Standard Deviation 9.90
|
-2.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-5.5 Grams per liter
Standard Deviation 3.54
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Hemoglobin,Week 8,n=2,1,2,0,2
|
-6.0 Grams per liter
Standard Deviation 14.14
|
-4.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
4.0 Grams per liter
Standard Deviation 12.73
|
—
|
-1.5 Grams per liter
Standard Deviation 10.61
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Hemoglobin,Week 12,n=1,1,1,1,1
|
-5.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
20.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
8.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
5.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Hemoglobin,Week 16,n=0,1,1,1,0
|
—
|
-2.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
19.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Hemoglobin,Week 24,n=0,1,0,0,0
|
—
|
-4.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Hemoglobin,Week 36,n=0,1,0,0,0
|
—
|
2.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Hematocrit,Week 2,n=1,1,0,1,2
|
-0.0080 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.0060 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
0.0250 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0235 Proportion of red blood cells in blood
Standard Deviation 0.01202
|
|
Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Hematocrit,Week 4,n=2,1,1,2,2
|
0.0030 Proportion of red blood cells in blood
Standard Deviation 0.00141
|
-0.0080 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.0250 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.0060 Proportion of red blood cells in blood
Standard Deviation 0.03111
|
0.0105 Proportion of red blood cells in blood
Standard Deviation 0.00354
|
|
Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Hematocrit,Week 8,n=2,1,1,2,2
|
0.0115 Proportion of red blood cells in blood
Standard Deviation 0.01909
|
-0.0110 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.0030 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.0040 Proportion of red blood cells in blood
Standard Deviation 0.01414
|
0.0260 Proportion of red blood cells in blood
Standard Deviation 0.02546
|
|
Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Hematocrit,Week 12,n=2,0,1,1,0
|
0.0125 Proportion of red blood cells in blood
Standard Deviation 0.01202
|
—
|
-0.0060 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.0420 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Hematocrit,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
-0.0080 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Hematocrit,Week 16,n=2,0,0,1,0
|
0.0000 Proportion of red blood cells in blood
Standard Deviation 0.00141
|
—
|
—
|
0.0080 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Hematocrit,Week 24,n=2,0,0,0,0
|
0.0040 Proportion of red blood cells in blood
Standard Deviation 0.02687
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Hematocrit,Week 36,n=2,0,0,0,0
|
0.0005 Proportion of red blood cells in blood
Standard Deviation 0.01626
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Hematocrit,Week 38,n=1,0,0,0,0
|
-0.0050 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Hematocrit,Week 40,n=1,0,0,0,0
|
-0.0140 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=3 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Hematocrit,Week 4,n=3,3,2,1,2
|
-0.0047 Proportion of red blood cells in blood
Standard Deviation 0.02570
|
-0.0057 Proportion of red blood cells in blood
Standard Deviation 0.01834
|
0.0115 Proportion of red blood cells in blood
Standard Deviation 0.02616
|
-0.0040 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.0070 Proportion of red blood cells in blood
Standard Deviation 0.00849
|
|
Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Hematocrit,Week 8,n=2,1,2,0,2
|
-0.0185 Proportion of red blood cells in blood
Standard Deviation 0.04879
|
0.0000 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0135 Proportion of red blood cells in blood
Standard Deviation 0.01768
|
—
|
-0.0120 Proportion of red blood cells in blood
Standard Deviation 0.00424
|
|
Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Hematocrit,Week 12,n=1,1,1,1,1
|
-0.0120 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0080 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0470 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.0010 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0030 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Hematocrit,Week 16,n=0,1,1,1,0
|
—
|
0.0060 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0610 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.0030 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Hematocrit,Week 24,n=0,1,0,0,0
|
—
|
0.0100 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Hematocrit,Week 36,n=0,1,0,0,0
|
—
|
0.0280 Proportion of red blood cells in blood
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 2,n=1,1,0,1,2
|
-2.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
0.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.5 Femtoliter
Standard Deviation 3.54
|
|
Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 4,n=2,1,1,2,2
|
1.5 Femtoliter
Standard Deviation 0.71
|
1.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.5 Femtoliter
Standard Deviation 0.71
|
0.5 Femtoliter
Standard Deviation 2.12
|
|
Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 8,n=2,1,1,2,1
|
1.5 Femtoliter
Standard Deviation 2.12
|
-1.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.5 Femtoliter
Standard Deviation 0.71
|
2.0 Femtoliter
Standard Deviation 2.83
|
|
Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 12,n=2,0,1,1,0
|
2.5 Femtoliter
Standard Deviation 0.71
|
—
|
0.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-6.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
-5.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 16,n=2,0,0,1,0
|
0.5 Femtoliter
Standard Deviation 0.71
|
—
|
—
|
-4.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 24,n=2,0,0,0,0
|
1.5 Femtoliter
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 36,n=2,0,0,0,0
|
2.5 Femtoliter
Standard Deviation 2.12
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 38,n=1,0,0,0,0
|
0.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 40,n=1,0,0,0,0
|
-2.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=3 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 8,n=2,1,2,0,2
|
-0.5 Femtoliter
Standard Deviation 0.71
|
1.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Femtoliter
Standard Deviation 1.41
|
—
|
1.5 Femtoliter
Standard Deviation 0.71
|
|
Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 4,n=3,3,2,1,2
|
0.7 Femtoliter
Standard Deviation 1.15
|
1.3 Femtoliter
Standard Deviation 1.53
|
0.0 Femtoliter
Standard Deviation 0.00
|
-3.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 Femtoliter
Standard Deviation 1.41
|
|
Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 12,n=1,1,1,1,1
|
0.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 16,n=0,1,1,1,0
|
—
|
1.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 24,n=0,1,0,0,0
|
—
|
3.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 36,n=0,1,0,0,0
|
—
|
4.0 Femtoliter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 2,n=1,1,0,1,2
|
-1.10 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.20 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
-0.20 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.60 Picograms
Standard Deviation 0.990
|
|
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 4,n=2,1,1,2,2
|
0.30 Picograms
Standard Deviation 0.000
|
0.60 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.20 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.05 Picograms
Standard Deviation 0.354
|
1.00 Picograms
Standard Deviation 1.273
|
|
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 8,n=2,1,1,2,2
|
0.30 Picograms
Standard Deviation 0.424
|
1.30 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.30 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.45 Picograms
Standard Deviation 0.919
|
0.70 Picograms
Standard Deviation 0.141
|
|
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 12,n=2,1,1,1,0
|
0.25 Picograms
Standard Deviation 0.212
|
NA Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.30 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.00 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
-0.90 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 16,n=2,0,0,1,0
|
0.00 Picograms
Standard Deviation 0.00
|
—
|
—
|
-0.10 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 24,n=2,0,0,0,0
|
0.10 Picograms
Standard Deviation 0.141
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 36,n=2,0,0,0,0
|
0.25 Picograms
Standard Deviation 0.354
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 38,n=1,0,0,0,0
|
-0.40 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 40,n=1,0,0,0,0
|
0.40 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=3 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 4,n=3,3,2,1,2
|
-0.33 Picograms
Standard Deviation 0.757
|
-0.47 Picograms
Standard Deviation 0.451
|
-0.25 Picograms
Standard Deviation 0.354
|
-1.00 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.00 Picograms
Standard Deviation 0.849
|
|
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 8,n=2,1,2,0,2
|
-0.15 Picograms
Standard Deviation 0.354
|
-0.60 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.00 Picograms
Standard Deviation 1.273
|
—
|
1.10 Picograms
Standard Deviation 2.121
|
|
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 12,n=1,1,1,1,1
|
-0.10 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.50 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.70 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.20 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.80 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 16,n=0,1,1,1,0
|
—
|
-0.80 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.20 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.30 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 24,n=0,1,0,0,0
|
—
|
-0.80 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 36,n=0,1,0,0,0
|
—
|
-0.20 Picograms
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 16,n=2,0,0,1,0
|
0.00 Trillion cells per liter
Standard Deviation 0.00
|
—
|
—
|
-0.20 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 2,n=1,1,0,1,2
|
0.00 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.10 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
0.30 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.25 Trillion cells per liter
Standard Deviation 0.071
|
|
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 4,n=2,1,1,2,2
|
0.00 Trillion cells per liter
Standard Deviation 0.000
|
-0.10 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.30 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.00 Trillion cells per liter
Standard Deviation 0.283
|
0.10 Trillion cells per liter
Standard Deviation 0.141
|
|
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 8,n=2,1,1,2,2
|
0.10 Trillion cells per liter
Standard Deviation 0.141
|
0.00 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.00 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.05 Trillion cells per liter
Standard Deviation 0.212
|
0.15 Trillion cells per liter
Standard Deviation 0.071
|
|
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 12,n=2,1,1,1,0
|
0.10 Trillion cells per liter
Standard Deviation 0.141
|
NA Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.00 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.20 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
0.10 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 24,n=2,0,0,0,0
|
0.00 Trillion cells per liter
Standard Deviation 0.283
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 36,n=2,0,0,0,0
|
-0.05 Trillion cells per liter
Standard Deviation 0.071
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 38,n=1,0,0,0,0
|
0.00 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 40,n=1,0,0,0,0
|
0.00 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=3 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 8,n=2,1,2,0,2
|
-0.15 Trillion cells per liter
Standard Deviation 0.495
|
0.00 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.10 Trillion cells per liter
Standard Deviation 0.283
|
—
|
-0.20 Trillion cells per liter
Standard Deviation 0.000
|
|
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 12,n=1,1,1,1,1
|
-0.10 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.10 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.60 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.00 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.10 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 4,n=3,3,2,1,2
|
-0.03 Trillion cells per liter
Standard Deviation 0.252
|
-0.10 Trillion cells per liter
Standard Deviation 0.173
|
0.10 Trillion cells per liter
Standard Deviation 0.283
|
0.10 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.20 Trillion cells per liter
Standard Deviation 0.000
|
|
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 16,n=0,1,1,1,0
|
—
|
0.10 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.70 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.10 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 24,n=0,1,0,0,0
|
—
|
0.00 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 36,n=0,1,0,0,0
|
—
|
0.10 Trillion cells per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Chloride,Week 4,n=2,1,1,2,2
|
-2.5 Millimoles per liter
Standard Deviation 0.71
|
1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
6.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.5 Millimoles per liter
Standard Deviation 2.12
|
1.5 Millimoles per liter
Standard Deviation 0.71
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Phosphate,Week 8,n=2,1,1,2,1
|
0.025 Millimoles per liter
Standard Deviation 0.1061
|
-0.200 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.150 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.075 Millimoles per liter
Standard Deviation 0.3182
|
-0.050 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Chloride,Week 8,n=2,1,1,2,1
|
-3.0 Millimoles per liter
Standard Deviation 1.41
|
0.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.0 Millimoles per liter
Standard Deviation 1.41
|
3.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Chloride,Week 12,n=2,1,1,1,0
|
-2.5 Millimoles per liter
Standard Deviation 0.71
|
NA Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Chloride,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Chloride,Week 16,n=2,0,0,1,0
|
-1.0 Millimoles per liter
Standard Deviation 0.00
|
—
|
—
|
0.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Chloride,Week 24,n=2,0,0,0,0
|
-2.0 Millimoles per liter
Standard Deviation 1.41
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Chloride,Week 36,n=2,0,0,0,0
|
0.5 Millimoles per liter
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Chloride,Week 38,n=1,0,0,0,0
|
-1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Chloride,Week 40,n=1,0,0,0,0
|
0.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Glucose,Week 2,n=1,1,0,1,2
|
0.80 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.20 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
1.30 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.25 Millimoles per liter
Standard Deviation 1.202
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Glucose,Week 4,n=2,1,1,2,2
|
0.95 Millimoles per liter
Standard Deviation 1.202
|
0.40 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.70 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.05 Millimoles per liter
Standard Deviation 2.192
|
-0.05 Millimoles per liter
Standard Deviation 0.212
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Glucose,Week 8,n=2,1,1,2,1
|
0.70 Millimoles per liter
Standard Deviation 0.424
|
0.00 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.10 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.30 Millimoles per liter
Standard Deviation 1.414
|
0.20 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Glucose,Week 12,n=2,1,1,1,0
|
0.60 Millimoles per liter
Standard Deviation 0.566
|
0.00 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.00 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.10 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Glucose,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
-0.10 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Glucose,Week 16,n=2,0,0,1,0
|
0.55 Millimoles per liter
Standard Deviation 0.071
|
—
|
—
|
-0.20 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Glucose,Week 24,n=2,0,0,0,0
|
0.65 Millimoles per liter
Standard Deviation 0.354
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Glucose,Week 36,n=2,0,0,0,0
|
0.35 Millimoles per liter
Standard Deviation 0.071
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Glucose,Week 38,n=1,0,0,0,0
|
0.50 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Glucose,Week 40,n=1,0,0,0,0
|
3.60 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Phosphate,Week 2,n=1,1,0,1,2
|
0.050 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.100 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
-0.300 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.000 Millimoles per liter
Standard Deviation 0.0707
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Phosphate,Week 4,n=2,1,1,2,2
|
-0.125 Millimoles per liter
Standard Deviation 0.1768
|
-0.250 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.000 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.050 Millimoles per liter
Standard Deviation 0.2828
|
-0.050 Millimoles per liter
Standard Deviation 0.1414
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Phosphate,Week 12,n=2,1,1,1,0
|
-0.025 Millimoles per liter
Standard Deviation 0.1768
|
NA Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.050 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.200 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Phosphate,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
0.250 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Phosphate,Week 16,n=2,0,0,1,0
|
-0.050 Millimoles per liter
Standard Deviation 0.0707
|
—
|
—
|
0.300 Millimoles per liter
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Phosphate,Week 24,n=2,0,0,0,0
|
0.050 Millimoles per liter
Standard Deviation 0.0000
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Phosphate,Week 36,n=2,0,0,0,0
|
-0.025 Millimoles per liter
Standard Deviation 0.0354
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Phosphate,Week 38,n=1,0,0,0,0
|
0.000 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Phosphate,Week 40,n=1,0,0,0,0
|
0.000 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Potassium,Week 2,n=1,1,0,1,2
|
0.10 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.20 Millimoles per liter
|
—
|
0.00 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.10 Millimoles per liter
Standard Deviation 0.283
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Potassium,Week 4,n=2,1,1,2,2
|
0.20 Millimoles per liter
Standard Deviation 0.283
|
-0.20 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.20 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.30 Millimoles per liter
Standard Deviation 0.141
|
0.00 Millimoles per liter
Standard Deviation 0.141
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Potassium,Week 8,n=2,1,1,2,1
|
0.10 Millimoles per liter
Standard Deviation 0.424
|
0.00 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.50 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.30 Millimoles per liter
Standard Deviation 0.424
|
0.10 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Potassium,Week 12,n=2,1,1,1,0
|
0.25 Millimoles per liter
Standard Deviation 0.636
|
NA Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.30 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.10 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Potassium,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
0.00 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Potassium,Week 16,n=2,0,0,1,0
|
0.00 Millimoles per liter
Standard Deviation 0.141
|
—
|
—
|
-0.10 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Potassium,Week 24,n=2,0,0,0,0
|
0.40 Millimoles per liter
Standard Deviation 0.283
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Potassium,Week 36,n=2,0,0,0,0
|
0.20 Millimoles per liter
Standard Deviation 0.424
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Potassium,Week 38,n=1,0,0,0,0
|
0.00 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Potassium,Week 40,n=1,0,0,0,0
|
-0.30 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Sodium,Week 2,n=1,1,0,1,2
|
0.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
-2.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.0 Millimoles per liter
Standard Deviation 0.00
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Sodium,Week 4,n=2,1,1,2,2
|
-0.5 Millimoles per liter
Standard Deviation 0.71
|
-1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
3.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.5 Millimoles per liter
Standard Deviation 4.95
|
0.5 Millimoles per liter
Standard Deviation 0.71
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Sodium,Week 8,n=2,1,1,2,1
|
-2.0 Millimoles per liter
Standard Deviation 1.41
|
-1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.5 Millimoles per liter
Standard Deviation 3.54
|
2.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Sodium,Week 12,n=2,1,1,1,0
|
-1.0 Millimoles per liter
Standard Deviation 1.41
|
NA Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Sodium,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
2.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Sodium,Week 16,n=2,0,0,1,0
|
-1.5 Millimoles per liter
Standard Deviation 0.71
|
—
|
—
|
0.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Sodium,Week 24,n=2,0,0,0,0
|
-0.5 Millimoles per liter
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Sodium,Week 36,n=2,0,0,0,0
|
2.0 Millimoles per liter
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Sodium,Week 38,n=1,0,0,0,0
|
-1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Sodium,Week 40,n=1,0,0,0,0
|
2.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Urea,Week 2,n=1,1,0,1,2
|
-1.00 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.50 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
0.50 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.75 Millimoles per liter
Standard Deviation 0.354
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Urea,Week 4,n=2,1,1,2,2
|
1.25 Millimoles per liter
Standard Deviation 0.354
|
-1.00 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.50 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.50 Millimoles per liter
Standard Deviation 0.707
|
0.25 Millimoles per liter
Standard Deviation 0.354
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Urea,Week 8,n=2,1,1,2,1
|
2.00 Millimoles per liter
Standard Deviation 2.121
|
-2.00 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
3.00 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.25 Millimoles per liter
Standard Deviation 0.354
|
0.50 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Urea,Week 12,n=2,1,1,1,0
|
-0.50 Millimoles per liter
Standard Deviation 2.121
|
NA Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.50 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.00 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Urea,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
1.00 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Urea,Week 16,n=2,0,0,1,0
|
1.25 Millimoles per liter
Standard Deviation 1.768
|
—
|
—
|
1.50 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Urea,Week 24,n=2,0,0,0,0
|
0.00 Millimoles per liter
Standard Deviation 0.000
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Urea,Week 36,n=2,0,0,0,0
|
0.00 Millimoles per liter
Standard Deviation 0.707
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Urea,Week 38,n=1,0,0,0,0
|
1.50 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Urea,Week 40,n=1,0,0,0,0
|
1.50 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Calcium,Week 2,n=1,1,0,1,2
|
0.060 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.000 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
0.100 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.040 Millimoles per liter
Standard Deviation 0.0000
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Calcium,Week 4,n=2,1,1,2,2
|
0.070 Millimoles per liter
Standard Deviation 0.0707
|
-0.100 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.080 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.050 Millimoles per liter
Standard Deviation 0.1273
|
0.000 Millimoles per liter
Standard Deviation 0.0566
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Calcium,Week 8,n=2,1,1,2,1
|
0.120 Millimoles per liter
Standard Deviation 0.0283
|
-0.140 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.000 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.020 Millimoles per liter
Standard Deviation 0.0849
|
0.020 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Calcium,Week 12,n=2,1,1,1,0
|
0.110 Millimoles per liter
Standard Deviation 0.0990
|
NA Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.000 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.040 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Calcium,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
0.000 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Calcium,Week 16,n=2,0,0,1,0
|
0.000 Millimoles per liter
Standard Deviation 0.1131
|
—
|
—
|
0.140 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Calcium,Week 24,n=2,0,0,0,0
|
0.040 Millimoles per liter
Standard Deviation 0.0566
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Calcium,Week 36,n=2,0,0,0,0
|
-0.050 Millimoles per liter
Standard Deviation 0.0707
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Calcium,Week 38,n=1,0,0,0,0
|
-0.020 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Calcium,Week 40,n=1,0,0,0,0
|
-0.020 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Carbon Dioxide,Week 2,n=1,1,0,1,2
|
3.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-5.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
-2.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.0 Millimoles per liter
Standard Deviation 0.00
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Carbon Dioxide,Week 4,n=2,1,1,2,2
|
3.5 Millimoles per liter
Standard Deviation 3.54
|
-3.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.5 Millimoles per liter
Standard Deviation 2.12
|
-3.5 Millimoles per liter
Standard Deviation 2.12
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Carbon Dioxide,Week 8,n=2,1,1,2,1
|
2.5 Millimoles per liter
Standard Deviation 2.12
|
-4.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.0 Millimoles per liter
Standard Deviation 0.00
|
-1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Carbon Dioxide,Week 12,n=2,1,1,1,0
|
3.5 Millimoles per liter
Standard Deviation 2.12
|
NA Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-3.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Carbon Dioxide,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Carbon Dioxide,Week 16,n=2,0,0,1,0
|
0.5 Millimoles per liter
Standard Deviation 0.71
|
—
|
—
|
-1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Carbon Dioxide,Week 24,n=2,0,0,0,0
|
3.0 Millimoles per liter
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Carbon Dioxide,Week 36,n=2,0,0,0,0
|
1.5 Millimoles per liter
Standard Deviation 4.95
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Carbon Dioxide,Week 38,n=1,0,0,0,0
|
1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Carbon Dioxide,Week 40,n=1,0,0,0,0
|
-2.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Chloride,Week 2,n=1,1,0,1,2
|
-1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
0.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.0 Millimoles per liter
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=3 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Chloride,Week 8,n=2,1,2,0,2
|
-2.0 Millimoles per liter
Standard Deviation 0.00
|
-1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.5 Millimoles per liter
Standard Deviation 2.12
|
—
|
0.5 Millimoles per liter
Standard Deviation 2.12
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Phosphate,Week 24,n=0,1,0,0,0
|
—
|
0.050 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Urea,Week 8,n=2,1,2,0,2
|
-0.50 Millimoles per liter
Standard Deviation 0.707
|
0.00 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.75 Millimoles per liter
Standard Deviation 0.354
|
—
|
0.50 Millimoles per liter
Standard Deviation 0.707
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Urea,Week 12,n=1,1,1,1,1
|
-0.50 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.50 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.00 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.00 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.50 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Calcium,Week 4,n=3,3,2,1,2
|
0.067 Millimoles per liter
Standard Deviation 0.0643
|
-0.093 Millimoles per liter
Standard Deviation 0.0462
|
0.060 Millimoles per liter
Standard Deviation 0.1414
|
0.120 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.040 Millimoles per liter
Standard Deviation 0.0566
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Calcium,Week 8,n=2,1,2,0,2
|
0.010 Millimoles per liter
Standard Deviation 0.0707
|
-0.060 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.050 Millimoles per liter
Standard Deviation 0.0707
|
—
|
0.020 Millimoles per liter
Standard Deviation 0.0000
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Calcium,Week 12,n=1,1,1,1,1
|
0.020 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.040 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.160 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.000 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.000 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Calcium,Week 16,n=0,1,1,1,0
|
—
|
0.040 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.180 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.060 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Calcium,Week 24,n=0,1,0,0,0
|
—
|
-0.040 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Calcium,Week 36,n=0,1,0,0,0
|
—
|
-0.020 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Carbon Dioxide,Week 4,n=3,3,2,1,2
|
0.0 Millimoles per liter
Standard Deviation 2.00
|
-2.7 Millimoles per liter
Standard Deviation 1.15
|
0.0 Millimoles per liter
Standard Deviation 2.83
|
-1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-3.0 Millimoles per liter
Standard Deviation 0.00
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Carbon Dioxide,Week 8,n=2,1,2,0,2
|
-0.5 Millimoles per liter
Standard Deviation 0.71
|
-4.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.5 Millimoles per liter
Standard Deviation 3.54
|
—
|
-1.5 Millimoles per liter
Standard Deviation 0.71
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Carbon Dioxide,Week 12,n=1,1,1,1,1
|
1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-3.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Carbon Dioxide,Week 16,n=0,1,1,1,0
|
—
|
0.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Carbon Dioxide,Week 24,n=0,1,0,0,0
|
—
|
1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Carbon Dioxide,Week 36,n=0,1,0,0,0
|
—
|
-2.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Chloride,Week 4,n=3,3,2,1,2
|
0.7 Millimoles per liter
Standard Deviation 1.15
|
0.3 Millimoles per liter
Standard Deviation 3.06
|
-2.5 Millimoles per liter
Standard Deviation 4.95
|
-4.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.5 Millimoles per liter
Standard Deviation 0.71
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Chloride,Week 12,n=1,1,1,1,1
|
-2.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-4.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Chloride,Week 16,n=0,1,1,1,0
|
—
|
1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-5.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Chloride,Week 24,n=0,1,0,0,0
|
—
|
1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Chloride,Week 36,n=0,1,0,0,0
|
—
|
0.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Glucose,Week 4,n=3,3,2,1,2
|
-0.10 Millimoles per liter
Standard Deviation 0.608
|
0.33 Millimoles per liter
Standard Deviation 1.115
|
-0.80 Millimoles per liter
Standard Deviation 0.849
|
0.70 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.40 Millimoles per liter
Standard Deviation 0.707
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Glucose,Week 8,n=2,1,2,0,2
|
0.15 Millimoles per liter
Standard Deviation 1.061
|
0.60 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.85 Millimoles per liter
Standard Deviation 0.071
|
—
|
0.55 Millimoles per liter
Standard Deviation 0.354
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Glucose,Week 12,n=1,1,1,1,1
|
0.00 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.80 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.30 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.50 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.20 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Glucose,Week 16,n=0,1,1,1,0
|
—
|
1.40 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.30 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.10 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Glucose,Week 24,n=0,1,0,0,0
|
—
|
1.10 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Glucose,Week 36,n=0,1,0,0,0
|
—
|
2.10 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Phosphate,Week 4,n=3,3,2,1,2
|
0.050 Millimoles per liter
Standard Deviation 0.2646
|
-0.033 Millimoles per liter
Standard Deviation 0.1155
|
-0.125 Millimoles per liter
Standard Deviation 0.1768
|
0.050 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.025 Millimoles per liter
Standard Deviation 0.1061
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Phosphate,Week 8,n=2,1,2,0,2
|
0.150 Millimoles per liter
Standard Deviation 0.1414
|
-0.100 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.250 Millimoles per liter
Standard Deviation 0.2121
|
—
|
-0.075 Millimoles per liter
Standard Deviation 0.0354
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Phosphate,Week 12,n=1,1,1,1,1
|
0.050 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.250 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.000 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.250 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.100 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Phosphate,Week 16,n=0,1,1,1,0
|
—
|
0.100 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.000 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.000 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Phosphate,Week 36,n=0,1,0,0,0
|
—
|
-0.150 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Potassium,Week 4,n=3,3,2,1,2
|
-0.27 Millimoles per liter
Standard Deviation 0.289
|
0.03 Millimoles per liter
Standard Deviation 0.321
|
0.10 Millimoles per liter
Standard Deviation 0.141
|
0.40 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.10 Millimoles per liter
Standard Deviation 0.141
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Potassium,Week 8,n=2,1,2,0,2
|
-0.25 Millimoles per liter
Standard Deviation 0.212
|
-0.30 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.00 Millimoles per liter
Standard Deviation 0.424
|
—
|
-0.10 Millimoles per liter
Standard Deviation 0.283
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Potassium,Week 12,n=1,1,1,1,1
|
-0.20 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.20 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.40 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.00 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.40 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Potassium,Week 16,n=0,1,1,1,0
|
—
|
-0.10 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.10 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.20 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Potassium,Week 24,n=0,1,0,0,0
|
—
|
-0.10 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Potassium,Week 36,n=0,1,0,0,0
|
—
|
-0.20 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Sodium,Week 4,n=3,3,2,1,2
|
0.3 Millimoles per liter
Standard Deviation 1.53
|
-1.0 Millimoles per liter
Standard Deviation 2.65
|
-3.0 Millimoles per liter
Standard Deviation 2.83
|
-3.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.0 Millimoles per liter
Standard Deviation 1.41
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Sodium,Week 8,n=2,1,2,0,2
|
-2.5 Millimoles per liter
Standard Deviation 0.71
|
2.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-3.5 Millimoles per liter
Standard Deviation 3.54
|
—
|
-1.0 Millimoles per liter
Standard Deviation 1.41
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Sodium,Week 12,n=1,1,1,1,1
|
-2.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-4.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-4.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Sodium,Week 16,n=0,1,1,1,0
|
—
|
0.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-4.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Sodium,Week 24,n=0,1,0,0,0
|
—
|
3.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Sodium,Week 36,n=0,1,0,0,0
|
—
|
1.0 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Urea,Week 4,n=3,3,2,1,2
|
-0.83 Millimoles per liter
Standard Deviation 0.577
|
-0.50 Millimoles per liter
Standard Deviation 1.323
|
-0.50 Millimoles per liter
Standard Deviation 0.707
|
0.00 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.25 Millimoles per liter
Standard Deviation 1.061
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Urea,Week 16,n=0,1,1,1,0
|
—
|
0.00 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.50 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.50 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Urea,Week 24,n=0,1,0,0,0
|
—
|
-0.50 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Urea,Week 36,n=0,1,0,0,0
|
—
|
-1.00 Millimoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Protein,Week 4,n=2,1,1,2,2
|
1.0 Grams per liter
Standard Deviation 1.41
|
0.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.5 Grams per liter
Standard Deviation 4.95
|
-0.5 Grams per liter
Standard Deviation 2.12
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Albumin,Week 2,n=1,1,0,1,2
|
-1.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
5.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
3.5 Grams per liter
Standard Deviation 0.71
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Albumin,Week 4,n=2,1,1,2,2
|
0.0 Grams per liter
Standard Deviation 1.41
|
0.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Grams per liter
Standard Deviation 2.83
|
3.0 Grams per liter
Standard Deviation 1.41
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Albumin,Week 8,n=2,1,1,2,1
|
1.0 Grams per liter
Standard Deviation 2.83
|
0.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.0 Grams per liter
Standard Deviation 2.83
|
2.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Albumin,Week 12,n=2,0,1,1,0
|
1.0 Grams per liter
Standard Deviation 0.00
|
—
|
1.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-4.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Albumin,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
0.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Albumin,Week 16,n=2,0,0,1,0
|
-0.5 Grams per liter
Standard Deviation 2.12
|
—
|
—
|
2.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Albumin,Week 24,n=2,0,0,0,0
|
-0.5 Grams per liter
Standard Deviation 3.54
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Albumin,Week 36,n=2,0,0,0,0
|
-1.0 Grams per liter
Standard Deviation 2.83
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Albumin,Week 38,n=1,0,0,0,0
|
-2.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Albumin,Week 40,n=1,0,0,0,0
|
-2.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Protein,Week 2,n=1,1,0,1,2
|
0.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
8.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.5 Grams per liter
Standard Deviation 2.12
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Protein,Week 8,n=2,1,1,2,1
|
3.0 Grams per liter
Standard Deviation 1.41
|
0.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.5 Grams per liter
Standard Deviation 4.95
|
0.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Protein,Week 12,n=2,0,1,1,0
|
2.5 Grams per liter
Standard Deviation 2.12
|
—
|
2.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-4.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Protein,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
-5.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Protein,Week 16,n=2,0,0,1,0
|
1.0 Grams per liter
Standard Deviation 1.41
|
—
|
—
|
-2.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Protein,Week 24,n=2,0,0,0,0
|
0.5 Grams per liter
Standard Deviation 3.54
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Protein,Week 36,n=2,0,0,0,0
|
1.5 Grams per liter
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Protein,Week 38,n=1,0,0,0,0
|
1.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Protein,Week 40,n=1,0,0,0,0
|
0.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=3 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Albumin,Week 4,n=3,3,2,1,2
|
-0.3 Grams per liter
Standard Deviation 1.53
|
-1.3 Grams per liter
Standard Deviation 0.58
|
1.0 Grams per liter
Standard Deviation 1.41
|
0.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.5 Grams per liter
Standard Deviation 0.71
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Albumin,Week 8,n=2,1,2,0,2
|
1.5 Grams per liter
Standard Deviation 2.12
|
-2.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.0 Grams per liter
Standard Deviation 2.83
|
—
|
-1.5 Grams per liter
Standard Deviation 0.71
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Albumin,Week 12,n=1,1,1,1,1
|
3.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
5.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
3.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Albumin,Week 16,n=0,1,1,1,0
|
—
|
-2.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
5.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Albumin,Week 24,n=0,1,0,0,0
|
—
|
-1.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Albumin,Week 36,n=0,1,0,0,0
|
—
|
-2.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Protein,Week 4,n=3,3,2,1,2
|
-0.3 Grams per liter
Standard Deviation 3.21
|
-2.7 Grams per liter
Standard Deviation 1.53
|
1.0 Grams per liter
Standard Deviation 5.66
|
0.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-5.0 Grams per liter
Standard Deviation 2.83
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Protein,Week 8,n=2,1,2,0,2
|
1.5 Grams per liter
Standard Deviation 3.54
|
-2.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.5 Grams per liter
Standard Deviation 4.95
|
—
|
-1.5 Grams per liter
Standard Deviation 3.54
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Protein,Week 12,n=1,1,1,1,1
|
3.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
9.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Protein,Week 16,n=0,1,1,1,0
|
—
|
-2.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
12.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Protein,Week 24,n=0,1,0,0,0
|
—
|
-1.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Protein,Week 36,n=0,1,0,0,0
|
—
|
-2.0 Grams per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
ALT,Week 2,n=1,1,0,1,2
|
1.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
4.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
3.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
72.5 International units per liter
Standard Deviation 101.12
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
ALT,Week 4,n=2,1,1,2,2
|
-1.5 International units per liter
Standard Deviation 3.54
|
4.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
4.0 International units per liter
Standard Deviation 9.90
|
51.5 International units per liter
Standard Deviation 64.35
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
ALT,Week 8,n=2,1,1,2,2
|
2.5 International units per liter
Standard Deviation 4.95
|
2.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
4.5 International units per liter
Standard Deviation 7.78
|
31.5 International units per liter
Standard Deviation 24.75
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
ALT,Week 12,n=2,0,1,1,0
|
-3.0 International units per liter
Standard Deviation 7.07
|
—
|
4.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-3.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
ALT,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
2.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
ALT,Week 16,n=2,0,0,1,0
|
-1.0 International units per liter
Standard Deviation 2.83
|
—
|
—
|
2.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
ALT,Week 24,n=2,0,0,0,0
|
-2.5 International units per liter
Standard Deviation 6.36
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
ALT,Week 36,n=2,0,0,0,0
|
-4.5 International units per liter
Standard Deviation 9.19
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
ALT,Week 38,n=1,0,0,0,0
|
-9.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
ALT,Week 40,n=1,0,0,0,0
|
-9.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
ALP,Week 2,n=1,1,0,1,2
|
7.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
-17.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-5.0 International units per liter
Standard Deviation 5.66
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
ALP,Week 4,n=2,1,1,2,2
|
5.5 International units per liter
Standard Deviation 0.71
|
-9.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-4.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-9.0 International units per liter
Standard Deviation 14.14
|
-7.0 International units per liter
Standard Deviation 5.66
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
ALP,Week 8,n=2,1,1,2,2
|
7.0 International units per liter
Standard Deviation 1.41
|
-16.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-3.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-4.5 International units per liter
Standard Deviation 26.16
|
-12.0 International units per liter
Standard Deviation 5.66
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
ALP,Week 12,n=2,0,1,1,0
|
5.0 International units per liter
Standard Deviation 1.41
|
—
|
2.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
8.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
ALP,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
-15.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
ALP,Week 16,n=2,0,0,1,0
|
-0.5 International units per liter
Standard Deviation 0.71
|
—
|
—
|
-9.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
ALP,Week 24,n=2,0,0,0,0
|
2.5 International units per liter
Standard Deviation 2.12
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
ALP,Week 36,n=2,0,0,0,0
|
2.0 International units per liter
Standard Deviation 5.66
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
ALP,Week 38,n=1,0,0,0,0
|
7.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
ALP,Week 40,n=1,0,0,0,0
|
18.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
AST,Week 2,n=1,1,0,1,2
|
0.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
3.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
44.5 International units per liter
Standard Deviation 57.28
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
AST,Week 4,n=2,1,1,2,2
|
-4.5 International units per liter
Standard Deviation 0.71
|
0.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.5 International units per liter
Standard Deviation 3.54
|
23.0 International units per liter
Standard Deviation 25.46
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
AST,Week 8,n=2,1,1,2,2
|
1.5 International units per liter
Standard Deviation 0.71
|
-2.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-3.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 International units per liter
Standard Deviation 4.24
|
14.0 International units per liter
Standard Deviation 5.66
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
AST,Week 12,n=2,0,1,1,0
|
-4.0 International units per liter
Standard Deviation 1.41
|
—
|
-1.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
AST,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
0.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
AST,Week 16,n=2,0,0,1,0
|
-3.0 International units per liter
Standard Deviation 2.83
|
—
|
—
|
1.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
AST,Week 24,n=2,0,0,0,0
|
-3.5 International units per liter
Standard Deviation 2.12
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
AST,Week 36,n=2,0,0,0,0
|
-4.5 International units per liter
Standard Deviation 4.95
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
AST,Week 38,n=1,0,0,0,0
|
-7.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
AST,Week 40,n=1,0,0,0,0
|
-7.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=3 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
ALT,Week 4,n=3,3,2,1,2
|
2.3 International units per liter
Standard Deviation 1.15
|
2.7 International units per liter
Standard Deviation 7.23
|
-8.0 International units per liter
Standard Deviation 4.24
|
103.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.0 International units per liter
Standard Deviation 0.00
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
ALT,Week 8,n=2,1,2,0,2
|
9.0 International units per liter
Standard Deviation 7.07
|
13.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-9.5 International units per liter
Standard Deviation 9.19
|
—
|
-1.5 International units per liter
Standard Deviation 3.54
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
ALT,Week 12,n=1,1,1,1,1
|
3.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
8.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-4.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
ALT,Week 16,n=0,1,1,1,0
|
—
|
-5.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-6.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
ALT,Week 24,n=0,1,0,0,0
|
—
|
0.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
ALT,Week 36,n=0,1,0,0,0
|
—
|
-4.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
ALP,Week 4,n=3,3,2,1,2
|
-0.7 International units per liter
Standard Deviation 3.79
|
0.0 International units per liter
Standard Deviation 4.36
|
0.5 International units per liter
Standard Deviation 3.54
|
81.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 International units per liter
Standard Deviation 14.14
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
ALP,Week 8,n=2,1,2,0,2
|
1.5 International units per liter
Standard Deviation 2.12
|
-1.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.0 International units per liter
Standard Deviation 4.24
|
—
|
-3.0 International units per liter
Standard Deviation 0.00
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
ALP,Week 12,n=1,1,1,1,1
|
-1.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
17.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-11.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-10.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
ALP,Week 16,n=0,1,1,1,0
|
—
|
4.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
3.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-10.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
ALP,Week 24,n=0,1,0,0,0
|
—
|
2.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
ALP,Week 36,n=0,1,0,0,0
|
—
|
4.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
AST,Week 4,n=3,3,2,1,2
|
0.7 International units per liter
Standard Deviation 1.53
|
2.0 International units per liter
Standard Deviation 3.00
|
-5.0 International units per liter
Standard Deviation 1.41
|
24.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.5 International units per liter
Standard Deviation 3.54
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
AST,Week 8,n=2,1,2,0,2
|
10.5 International units per liter
Standard Deviation 9.19
|
7.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-6.0 International units per liter
Standard Deviation 2.83
|
—
|
0.0 International units per liter
Standard Deviation 5.66
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
AST,Week 12,n=1,1,1,1,1
|
1.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
AST,Week 16,n=0,1,1,1,0
|
—
|
-4.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
AST,Week 24,n=0,1,0,0,0
|
—
|
-1.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
AST,Week 36,n=0,1,0,0,0
|
—
|
-3.0 International units per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Creatinine,Week 4,n=2,1,1,2,2
|
-11.05 Micromoles per liter
Standard Deviation 9.405
|
-12.40 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.70 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.30 Micromoles per liter
Standard Deviation 0.566
|
2.20 Micromoles per liter
Standard Deviation 4.384
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Bilirubin,Week 2,n=1,1,0,1,2
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.0 Micromoles per liter
Standard Deviation 1.41
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Bilirubin,Week 4,n=2,1,1,2,2
|
5.0 Micromoles per liter
Standard Deviation 1.41
|
-2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.0 Micromoles per liter
Standard Deviation 1.41
|
1.0 Micromoles per liter
Standard Deviation 1.41
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Bilirubin,Week 8,n=2,1,1,2,2
|
-1.0 Micromoles per liter
Standard Deviation 4.24
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.0 Micromoles per liter
Standard Deviation 4.24
|
2.0 Micromoles per liter
Standard Deviation 0.00
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Bilirubin,Week 12,n=2,0,1,1,0
|
0.0 Micromoles per liter
Standard Deviation 8.49
|
—
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Bilirubin,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Bilirubin,Week 16,n=2,0,0,1,0
|
5.0 Micromoles per liter
Standard Deviation 4.24
|
—
|
—
|
2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Bilirubin,Week 24,n=2,0,0,0,0
|
-2.0 Micromoles per liter
Standard Deviation 5.66
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Bilirubin,Week 36,n=2,0,0,0,0
|
1.0 Micromoles per liter
Standard Deviation 7.07
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Bilirubin,Week 38,n=1,0,0,0,0
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Bilirubin,Week 40,n=1,0,0,0,0
|
2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Direct Bilirubin,Week 2,n=1,1,0,1,2
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Micromoles per liter
Standard Deviation 0.00
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Direct Bilirubin,Week 4,n=2,1,1,2,2
|
1.0 Micromoles per liter
Standard Deviation 1.41
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.0 Micromoles per liter
Standard Deviation 1.41
|
0.0 Micromoles per liter
Standard Deviation 0.00
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Direct Bilirubin,Week 8,n=2,1,1,2,1
|
0.0 Micromoles per liter
Standard Deviation 2.83
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
1.0 Micromoles per liter
Standard Deviation 1.41
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Direct Bilirubin,Week 12,n=2,0,1,1,0
|
0.0 Micromoles per liter
Standard Deviation 2.83
|
—
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Direct Bilirubin,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Direct Bilirubin,Week 16,n=2,0,0,1,0
|
1.0 Micromoles per liter
Standard Deviation 1.41
|
—
|
—
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Direct Bilirubin,Week 24,n=2,0,0,0,0
|
0.0 Micromoles per liter
Standard Deviation 0.00
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Direct Bilirubin,Week 36,n=2,0,0,0,0
|
-1.0 Micromoles per liter
Standard Deviation 1.41
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Direct Bilirubin,Week 38,n=1,0,0,0,0
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Direct Bilirubin,Week 40,n=1,0,0,0,0
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Indirect Bilirubin,Week 2,n=1,1,0,1,2
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-1.0 Micromoles per liter
Standard Deviation 1.41
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Indirect Bilirubin,Week 4,n=2,1,1,2,2
|
4.0 Micromoles per liter
Standard Deviation 0.00
|
-2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Micromoles per liter
Standard Deviation 0.00
|
1.0 Micromoles per liter
Standard Deviation 1.41
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Indirect Bilirubin,Week 8,n=2,1,1,2,1
|
-1.0 Micromoles per liter
Standard Deviation 1.41
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Micromoles per liter
Standard Deviation 2.83
|
2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Indirect Bilirubin,Week 12,n=2,0,1,1,0
|
0.0 Micromoles per liter
Standard Deviation 5.66
|
—
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Indirect Bilirubin,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Indirect Bilirubin,Week 16,n=2,0,0,1,0
|
4.0 Micromoles per liter
Standard Deviation 5.66
|
—
|
—
|
2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Indirect Bilirubin,Week 24,n=2,0,0,0,0
|
-2.0 Micromoles per liter
Standard Deviation 5.66
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Indirect Bilirubin,Week 36,n=2,0,0,0,0
|
2.0 Micromoles per liter
Standard Deviation 8.49
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Indirect Bilirubin,Week 38,n=1,0,0,0,0
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Indirect Bilirubin,Week 40,n=1,0,0,0,0
|
2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Creatinine,Week 2,n=1,1,0,1,2
|
-3.50 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-6.20 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
1.80 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
3.10 Micromoles per liter
Standard Deviation 1.838
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Creatinine,Week 8,n=2,1,1,2,1
|
-8.40 Micromoles per liter
Standard Deviation 6.930
|
-8.00 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
9.70 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.45 Micromoles per liter
Standard Deviation 5.728
|
0.00 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Creatinine,Week 12,n=2,0,1,1,0
|
-11.90 Micromoles per liter
Standard Deviation 11.879
|
—
|
4.40 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-0.90 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Creatinine,Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
0.80 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Creatinine,Week 16,n=2,0,0,1,0
|
-12.80 Micromoles per liter
Standard Deviation 5.657
|
—
|
—
|
4.40 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Creatinine,Week 24,n=2,0,0,0,0
|
-9.75 Micromoles per liter
Standard Deviation 12.516
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Creatinine,Week 36,n=2,0,0,0,0
|
-15.05 Micromoles per liter
Standard Deviation 9.970
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Creatinine,Week 38,n=1,0,0,0,0
|
-19.40 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Creatinine,Week 40,n=1,0,0,0,0
|
-20.30 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 4,8,12,16,24 and 36Population: Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=3 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Bilirubin,Week 8,n=2,1,2,0,2
|
3.0 Micromoles per liter
Standard Deviation 4.24
|
2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-4.0 Micromoles per liter
Standard Deviation 2.83
|
—
|
-6.0 Micromoles per liter
Standard Deviation 5.66
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Creatinine,Week 4,n=3,3,2,1,2
|
-7.07 Micromoles per liter
Standard Deviation 7.887
|
-0.63 Micromoles per liter
Standard Deviation 4.842
|
-1.30 Micromoles per liter
Standard Deviation 9.334
|
-0.90 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
3.95 Micromoles per liter
Standard Deviation 19.445
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Creatinine,Week 8,n=2,1,2,0,2
|
-8.40 Micromoles per liter
Standard Deviation 0.566
|
-18.60 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-5.25 Micromoles per liter
Standard Deviation 3.748
|
—
|
-5.75 Micromoles per liter
Standard Deviation 5.728
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Bilirubin,Week 4,n=3,3,2,1,2
|
0.7 Micromoles per liter
Standard Deviation 3.06
|
1.3 Micromoles per liter
Standard Deviation 3.06
|
-5.0 Micromoles per liter
Standard Deviation 1.41
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-8.0 Micromoles per liter
Standard Deviation 2.83
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Bilirubin,Week 12,n=1,1,1,1,1
|
4.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
4.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-8.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Bilirubin,Week 16,n=0,1,1,1,0
|
—
|
-2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
4.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Bilirubin,Week 24,n=0,1,0,0,0
|
—
|
-2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Bilirubin,Week 36,n=0,1,0,0,0
|
—
|
-4.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Direct Bilirubin,Week 4,n=3,3,2,1,2
|
0.0 Micromoles per liter
Standard Deviation 0.00
|
0.0 Micromoles per liter
Standard Deviation 0.00
|
0.0 Micromoles per liter
Standard Deviation 0.00
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.0 Micromoles per liter
Standard Deviation 0.00
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Direct Bilirubin,Week 8,n=2,1,2,0,2
|
1.0 Micromoles per liter
Standard Deviation 1.41
|
2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Micromoles per liter
Standard Deviation 0.00
|
—
|
-2.0 Micromoles per liter
Standard Deviation 0.00
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Direct Bilirubin,Week 12,n=1,1,1,1,1
|
2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Direct Bilirubin,Week 16,n=0,1,1,1,0
|
—
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Direct Bilirubin,Week 24,n=0,1,0,0,0
|
—
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Direct Bilirubin,Week 36,n=0,1,0,0,0
|
—
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Indirect Bilirubin,Week 4,n=3,3,2,1,2
|
0.7 Micromoles per liter
Standard Deviation 3.06
|
1.3 Micromoles per liter
Standard Deviation 3.06
|
-5.0 Micromoles per liter
Standard Deviation 1.41
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-6.0 Micromoles per liter
Standard Deviation 2.83
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Indirect Bilirubin,Week 8,n=2,1,2,0,2
|
2.0 Micromoles per liter
Standard Deviation 2.83
|
0.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-4.0 Micromoles per liter
Standard Deviation 2.83
|
—
|
-4.0 Micromoles per liter
Standard Deviation 5.66
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Indirect Bilirubin,Week 12,n=1,1,1,1,1
|
2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-4.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
4.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-6.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Indirect Bilirubin,Week 16,n=0,1,1,1,0
|
—
|
-2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
4.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Indirect Bilirubin,Week 24,n=0,1,0,0,0
|
—
|
-2.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Indirect Bilirubin,Week 36,n=0,1,0,0,0
|
—
|
-4.0 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Creatinine,Week 12,n=1,1,1,1,1
|
-6.20 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-27.40 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
5.30 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
9.70 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
-19.50 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Creatinine,Week 16,n=0,1,1,1,0
|
—
|
-19.50 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
5.30 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
5.30 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Creatinine,Week 24,n=0,1,0,0,0
|
—
|
-27.40 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
|
Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Creatinine,Week 36,n=0,1,0,0,0
|
—
|
-21.20 Micromoles per liter
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38Population: ITT-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who received at least one dose of 100mg open label Sirukumab was presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 2, n=0,0,0,1,1
|
—
|
—
|
—
|
561.000 Milligrams
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
550.000 Milligrams
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 4,n=0,0,0,2,1
|
—
|
—
|
—
|
596.125 Milligrams
Standard Deviation 586.7219
|
775.000 Milligrams
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 8,n=0,0,0,2,0
|
—
|
—
|
—
|
956.125 Milligrams
Standard Deviation 851.8869
|
—
|
|
Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 12,n=0,0,0,2,1
|
—
|
—
|
—
|
1201.125 Milligrams
Standard Deviation 1000.3793
|
1600.000 Milligrams
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 14,n=0,0,0,1,0
|
—
|
—
|
—
|
843.750 Milligrams
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 16,n=0,0,0,1,0
|
—
|
—
|
—
|
1233.750 Milligrams
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 24,n=0,0,0,1,0
|
—
|
—
|
—
|
1853.750 Milligrams
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 28,n=0,0,0,1,0
|
—
|
—
|
—
|
1908.500 Milligrams
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 32,n=0,0,0,0,1
|
—
|
—
|
—
|
—
|
1600.000 Milligrams
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B
Week 38,n=0,0,0,1,0
|
—
|
—
|
—
|
2153.750 Milligrams
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38Population: ITT-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who never received 100 mg open label Sirukumab has been presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=3 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 4,n=0,0,0,1,1
|
—
|
—
|
—
|
203.750 Milligrams
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
325.000 Milligrams
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 8,n=0,0,0,1,1
|
—
|
—
|
—
|
357.500 Milligrams
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
596.250 Milligrams
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 12,n=0,0,0,0,1
|
—
|
—
|
—
|
—
|
830.000 Milligrams
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 16,n=0,0,0,0,1
|
—
|
—
|
—
|
—
|
1020.000 Milligrams
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
|
Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 24,n=0,0,0,1,0
|
—
|
—
|
—
|
397.500 Milligrams
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
—
|
|
Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B
Week 32,n=0,0,0,0,1
|
—
|
—
|
—
|
—
|
1211.250 Milligrams
Standard Deviation NA
NA indicates data is not available since standard deviation was not derived because only one participant was available at the time of analysis
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40Population: ITT-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants. Data for number of disease flares per participant over time for part B were presented.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=8 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=5 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=4 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=5 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=4 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Number of Disease Flares Over Time
Week 40, n=1,0,0,0,0
|
2 Disease flares
|
—
|
—
|
—
|
—
|
|
Part B: Number of Disease Flares Over Time
Week 2, n=1,1,0,1,2
|
0 Disease flares
|
0 Disease flares
|
—
|
0 Disease flares
|
0 Disease flares
|
|
Part B: Number of Disease Flares Over Time
Week 4, n=5,4,4,3,4
|
0 Disease flares
|
0 Disease flares
|
0 Disease flares
|
0 Disease flares
|
0 Disease flares
|
|
Part B: Number of Disease Flares Over Time
Week 8, n=4,2,3,2,3
|
0 Disease flares
|
0 Disease flares
|
1 Disease flares
|
0 Disease flares
|
0 Disease flares
|
|
Part B: Number of Disease Flares Over Time
Week 12, n=3,2,2,2,1
|
0 Disease flares
|
0 Disease flares
|
1 Disease flares
|
0 Disease flares
|
0 Disease flares
|
|
Part B: Number of Disease Flares Over Time
Week 14, n=0,0,0,1,0
|
—
|
—
|
—
|
1 Disease flares
|
—
|
|
Part B: Number of Disease Flares Over Time
Week 16, n=2,1,1,2,0
|
0 Disease flares
|
0 Disease flares
|
0 Disease flares
|
1 Disease flares
|
—
|
|
Part B: Number of Disease Flares Over Time
Week 24, n=2,1,0,0,0
|
0 Disease flares
|
0 Disease flares
|
—
|
—
|
—
|
|
Part B: Number of Disease Flares Over Time
Week 36, n=2,1,0,0,0
|
0 Disease flares
|
0 Disease flares
|
—
|
—
|
—
|
|
Part B: Number of Disease Flares Over Time
Week 38, n=1,0,0,0,0
|
2 Disease flares
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40Population: ITT-Part B Population.
Number of participants with at least one flare at a given visit was the number of participants with at least one flare between first SC IP intake and the day of the given visit. The hospitalizations for disease flare were planned to be identified through the adjudication of adverse events of special interest, and include events from the category: "Severe Flare including Hospitalizations". Data for participants requiring hospitalizations for disease flare for part B was not available due to early termination of study.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=8 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=5 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=4 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=5 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=4 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Number of Participants Requiring at Least One Hospitalization for Disease Flare
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 104Population: ITT-Part B Population.
Number of participants with at least one flare at a given visit was the number of participants with at least one flare between first SC IP intake and the day of the given visit. The hospitalizations for disease flare were planned to be identified through the adjudication of adverse events of special interest, and include events from the category: "Severe Flare including Hospitalizations". Data for participants requiring hospitalizations for disease flare for part B was not available due to early termination of study.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=8 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=5 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=4 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=5 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=4 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Number of Hospitalizations for Disease Flare Over Time
|
0 Number of hospitalizations
|
0 Number of hospitalizations
|
0 Number of hospitalizations
|
0 Number of hospitalizations
|
0 Number of hospitalizations
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week 24Population: ITT-Part B Population
SF-36v2 acute health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for participants (Par) who received at least one dose of 100 mg OL Sirukumab has been presented. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Physical Functioning
|
9.99 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Role Physical
|
37.5 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Bodily Pain
|
23 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, General Health
|
5 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Vitality
|
6.25 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Social Functioning
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Role Emotional
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Mental Health
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Physical Component Summary
|
9.98 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Mental Component Summary
|
-2.78 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Physical Functioning
|
4.99 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Role Physical
|
50 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Bodily Pain
|
49 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Vitality
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, General Health
|
10 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Vitality
|
-6.25 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Day 162, General Health
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-7 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Day 91, Vitality
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-6.25 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 8, Day 87, Vitality
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Physical Functioning
|
-10 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Role Physical
|
-12.5 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Bodily Pain
|
-39 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, General Health
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Vitality
|
-6.25 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Social Functioning
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Mental Health
|
10 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Physical Component Summary
|
-8.76 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Mental Component Summary
|
3.29 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Role Emotional
|
-8.33 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Physical Functioning
|
-4.99 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, General Health
|
10 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Social Functioning
|
12.5 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Role Emotional
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Mental Health
|
-10 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Physical Component Summary
|
15.7 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Mental Component Summary
|
-5.84 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Physical Functioning
|
24.99 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Role Physical
|
50 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Role Physical
|
-12.5 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Bodily Pain
|
33 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, General Health
|
5 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Vitality
|
-6.25 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Bodily Pain
|
1 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, General Health
|
-5 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Vitality
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Social Functioning
|
12.5 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Social Functioning
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Role Emotional
|
-16.67 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Mental Health
|
5 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Physical Component Summary
|
-2.09 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Mental Component Summary
|
-0.76 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Role Emotional
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Mental Health
|
-20 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Physical Component Summary
|
17.37 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Mental Component Summary
|
-10.18 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Physical Functioning
|
-5.01 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Role Physical
|
37.5 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Bodily Pain
|
11 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Social Functioning
|
12.5 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Role Emotional
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Mental Health
|
-15 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Physical Component Summary
|
8.12 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Mental Component Summary
|
-4.89 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Day 113, Physical Functioning
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-10 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Day 113, Role Physical
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Day 113, Bodily Pain
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Day 113, Mental Component Summary
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-1.05 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Week 12, Physical Functioning
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
15 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Week 12, Role Physical
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
6.25 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Week 12, Bodily Pain
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
33 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Week 12, General Health
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-5 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Week 12, Vitality
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Week 12, Social Functioning
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Week 12, Role Emotional
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Week 12, Mental Health
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
5 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Week 12, Physical Component Summary
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
6.28 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Week 12, Mental Component Summary
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-1.59 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 12, Physical Functioning
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
5 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 12, Role Physical
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-18.75 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 12, Bodily Pain
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-16 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 12, General Health
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
10 Scores on scale
|
10 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 12, Vitality
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
6.25 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 12, Social Functioning
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-25 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 12, Role Emotional
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-16.66 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 12, Mental Health
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-5 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 12, Physical Component Summary
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-0.34 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 12, Mental Component Summary
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-5.35 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Day 162, Physical Functioning
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
10.01 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Day 162, Role Physical
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-18.75 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Day 162, Bodily Pain
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-16 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Day 162, Vitality
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-12.5 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Day 162, Social Functioning
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-25 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Day 162, Role Emotional
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-33.33 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Day 162, Mental Health
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
5 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Day 162, Physical Component Summary
|
168 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-1.62 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Day 162, Mental Component Summary
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-8.24 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Day 91, Physical Functioning
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-15 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Day 91, Role Physical
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-25 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Day 91, Bodily Pain
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
22 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Day 91, General Health
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Day 91, Social Functioning
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Day 91, Role Emotional
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Day 91, Mental Health
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
20 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Day 91, Physical Component Summary
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-5.17 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Day 91, Mental Component Summary
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
5.95 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Day 85, Physical Functioning
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-10.01 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Day 85, Role Physical
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-6.25 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Day 85, Bodily Pain
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-22 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Day 85, General Health
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
10 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Day 85, Vitality
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-12.5 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Day 85, Social Functioning
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Day 85, Role Emotional
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Day 85, Mental Health
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
5 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Day 85, Physical Component Summary
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-4.79 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Day 113, General Health
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-5 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Day 113, Vitality
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-6.25 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Day 113, Social Functioning
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Day 113, Role Emotional
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Day 113, Mental Health
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-5 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Day 113, Physical Component Summary
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-1.72 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Day 85, Mental Component Summary
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1.82 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 8, Day 87, Physical Functioning
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 8, Day 87, Role Physical
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
6.25 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 8, Day 87, Bodily Pain
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
21 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 8, Day 87, General Health
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 8, Day 87, Social Functioning
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
12.5 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 8, Day 87, Role Emotional
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
16.66 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 8, Day 87, Mental Health
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
5 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 8, Day 87, Physical Component Summary
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1.52 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 8, Day 87, Mental Component Summary
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
4.54 Scores on scale
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Day 23, Day 29, Day 30, Day 57, Day 59, Day 64, Day 65 , Day 85, Day 112, Day 113, Day 163, Day 169, Day 373, Week 8 and Week 12Population: ITT-Part B Population
SF-36v2 acute health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for participants (Par) who never received 100 mg OL Sirukumab has been presented. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 23, Physical Functioning
|
25 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 23, Vitality
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Bodily Pain
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Vitality
|
6.25 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Social Functioning
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Physical Component Summary
|
4.88 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Mental Component Summary
|
-1.45 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 113, Bodily Pain
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Week 8, Physical Functioning
|
-5 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Week 8, Social Functioning
|
-12.5 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 85, Social Functioning
|
-12.5 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 65, Physical Functioning
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Week 12, Physical Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-3.33 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 373, Bodily Pain
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
16 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 373, Social Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 373, Mental Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-6.1 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 64, Role Physical
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-6.25 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 64, Vitality
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-12.5 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 64, Social Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 64, Role emotional
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
25 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 64, Mental health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-15 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 64, Mental Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.02 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 9, Day 29, Physical Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
10 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 9, Day 29, Vitality
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 9, Day 29, Mental health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-10 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 9, Day 29, Physical Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
3.22 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 10, Day 57, General health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-5 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 10, Day 57, Vitality
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 10, Day 57, Social Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
12.5 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 10, Day 57, Role emotional
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 10, Day 57, Physical Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.95 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 10, Day 57, Mental Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.83 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Week 12, Physical Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-29.99 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Week 12, Bodily Pain
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Week 12, Vitality
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-6.25 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Week 12, Physical Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-9.37 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Day 163, Physical Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-15.01 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Day 163, Bodily Pain
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 12, Day 85, Mental health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
5 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 13, Day 59, Physical Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
2.16 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 14, Day 57, Role Physical
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-18.75 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 14, Day 57, Mental health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
15 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 14, Day 57, Physical Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-7.54 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 17, Day 85, Social Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-12.5 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Week 8, Physical Component Summary
|
-2.1 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Week 8, Mental Component Summary
|
1.1 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 85, Physical Functioning
|
5 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 85, Role Physical
|
-6.25 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 85, Bodily Pain
|
10 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 85, General health
|
-22 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 85, Vitality
|
-6.25 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 85, Role emotional
|
8.33 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 85, Mental health
|
10 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 85, Physical Component Summary
|
-3.17 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 85, Mental Component Summary
|
1.62 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 65, Role Physical
|
6.25 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 65, Bodily Pain
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 65, General health
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 65, Vitality
|
-6.25 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 65, Social Functioning
|
12.5 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 65, Role emotional
|
8.33 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 65, Mental health
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 65, Physical Component Summary
|
-0.01 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 65, Mental Component Summary
|
1.88 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Week 12, Physical Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Week 12, Role Physical
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
6.25 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Week 12, Bodily Pain
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
16 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Week 12, General health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Week 12, Vitality
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-6.25 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Week 12, Social Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Week 12, Role emotional
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Week 12, Mental health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-5 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Week 12, Mental Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-2.88 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 373, Physical Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
15 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 373, Role Physical
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
6.25 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 373, General health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
8 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 373, Vitality
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 373, Role emotional
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 373, Mental health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-15 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 373, Physical Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
7.95 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 64, Physical Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
5 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 64, Bodily Pain
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-22 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 64, General health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 64, Physical Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-3.24 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 9, Day 29, Role Physical
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
6.25 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 9, Day 29, Bodily Pain
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 9, Day 29, General health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-3 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 9, Day 29, Social Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 9, Day 29, Role emotional
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 9, Day 29, Mental Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-3.68 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 10, Day 57, Physical Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 10, Day 57, Role Physical
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
12.5 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 10, Day 57, Bodily Pain
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 10, Day 57, Mental health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Week 12, Role Physical
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-18.75 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Week 12, General health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-13 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Week 12, Social Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-25 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Week 12, Role emotional
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Week 12, Mental health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
5 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Week 12, Mental Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1.44 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Day 163, Role Physical
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
6.25 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Day 163, General health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-8 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Day 163, Vitality
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Day 163, Social Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-37.5 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Day 163, Role emotional
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
9 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Day 163, Mental health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
10 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Day 163, Physical Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-3.64 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Day 163, Mental Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-0.4 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 12, Day 85, Physical Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-5 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 12, Day 85, Role Physical
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-6.25 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 15, Day 169, Mental health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 12, Day 85, Bodily Pain
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-11 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 12, Day 85, General health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-5 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 12, Day 85, Vitality
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
6.25 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 12, Day 85, Social Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 12, Day 85, Role emotional
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-16.67 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 12, Day 85, Physical Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-2.76 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 12, Day 85, Mental Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0.13 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 13, Day 59, Physical Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
5 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 13, Day 59, Role Physical
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-12.5 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 13, Day 59, Bodily Pain
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 13, Day 59, General health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 13, Day 59, Vitality
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 13, Day 59, Social Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-12.5 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 13, Day 59, Role emotional
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 13, Day 59, Mental health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-25 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 13, Day 59, Mental Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-7.59 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 14, Day 57, Physical Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-5.01 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 14, Day 57, Bodily Pain
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-32 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 14, Day 57, General health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
10 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 14, Day 57, Vitality
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
12.5 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 14, Day 57, Social Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-37.5 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 14, Day 57, Role emotional
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 17, Day 85, Role emotional
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 17, Day 85, Mental health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
5 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 17, Day 85, Physical Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-6.51 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 17, Day 85, Mental Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
3.01 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 14, Day 57, Mental Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
3.62 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 15, Day 169, Physical Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
4.99 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 15, Day 169, Role Physical
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
50 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 15, Day 169, Bodily Pain
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
33 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 15, Day 169, General health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
5 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 15, Day 169, Vitality
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
6.25 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 15, Day 169, Social Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
25 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 15, Day 169, Role emotional
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
50 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 15, Day 169, Physical Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
7.93 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 15, Day 169, Mental Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
8.48 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Week 12, Physical Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
5 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Week 12, Role Physical
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
6.25 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Week 12, Bodily Pain
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
28 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Week 12, General health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Week 12, Vitality
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-6.25 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Week 12, Social Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Week 12, Role emotional
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Week 12, Mental health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Week 12, Physical Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
5.1 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Week 12, Mental Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-2.52 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Day 112, Physical Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Day 112, Role Physical
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
12.5 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Day 112, Bodily Pain
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
28 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Day 112, General health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-20 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Day 112, Vitality
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-6.25 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Day 112, Social Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Day 112, Role emotional
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Day 112, Mental health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Day 112, Physical Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
2.71 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Day 112, Mental Component Summary
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-2.21 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 17, Day 85, Physical Functioning
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-10 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 17, Day 85, Role Physical
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-25 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 17, Day 85, Bodily Pain
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-10 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 17, Day 85, General health
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 17, Day 85, Vitality
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
6.25 Scores on scale
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 30, Physical Functioning
|
-5 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 30, Role Physical
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 30, Bodily Pain
|
-16 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 30, General health
|
10 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 30, Vitality
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 30, Social Functioning
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 30, Role emotional
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 30, Mental health
|
5 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 30, Physical Component Summary
|
-2.26 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 30, Mental Component Summary
|
2.26 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 29, Physical Functioning
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 29, Role Physical
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 29, Bodily Pain
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 29, General health
|
8 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 29, Vitality
|
6.25 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 29, Social Functioning
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 29, Role emotional
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 29, Mental health
|
10 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 29, Physical Component Summary
|
-0.12 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 29, Mental Component Summary
|
3.18 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 23, Role Physical
|
6.25 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 23, Bodily Pain
|
49 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 23, General health
|
10 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 23, Social Functioning
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 23, Role emotional
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 23, Mental health
|
-5 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 23, Physical Component Summary
|
12.88 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 23, Mental Component Summary
|
-5.75 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Physical Functioning
|
15 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Role Physical
|
18.75 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, General health
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Role emotional
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Mental health
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 113, Physical Functioning
|
15 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 113, Role Physical
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 113, General health
|
10 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 113, Vitality
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 113, Social Functioning
|
-12.5 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 113, Role emotional
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 113, Mental health
|
25 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 113, Physical Component Summary
|
0.77 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 113, Mental Component Summary
|
3.61 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Week 8, Role Physical
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Week 8, Bodily Pain
|
10 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Week 8, General health
|
-10 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Week 8, Vitality
|
-6.25 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Week 8, Role emotional
|
16.67 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Week 8, Mental health
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week24Population: ITT-Part B Population
EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). Baseline was last measurement done up to and including Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24
|
0.041 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Day 91
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.000 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12
|
-0.127 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24
|
-0.098 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339
|
-0.070 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12
|
0.204 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344
|
0.110 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Day 113
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.000 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Week 12
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.097 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 12
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.028 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Day 162
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.028 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Day 85
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.000 Scores on scale
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 8, Day 87
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.012 Scores on scale
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Day 29, 30, 57, 59, 64, 65, 85, 112, 113,163,169 and 373, Week 12Population: ITT-Part B Population
EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). Baseline was last measurement done up to and including Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=3 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 3, Day 29
|
0.233 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 4, Week 12
|
0.000 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 4, Day 113
|
0.000 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 11, Day 163
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0.042 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 17,Week 12
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.163 Scores on scale
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 12, Day 85
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-0.059 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 1, Day 30
|
-0.248 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 2, Day 29
|
0.000 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 5, Day 85
|
-0.015 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 6, Day 65
|
0.163 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 7, Week 12
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.163 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 7, Day 373
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.163 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 8, Day 64
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-0.016 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 9, Day 29
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.212 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 10, Day 57
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.000 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 11, Week 12
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-0.069 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 13, Day 59
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0.000 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 14, Day 57
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.000 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 16, Day 169
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.232 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 17, Day 112
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.163 Scores on scale
|
|
Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 18, Day 85
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-0.042 Scores on scale
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Day 85,87,91,113,162, 344,339,Week 12, 24Population: ITT-Part B Population
The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, I Feel Fatigued
|
2 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Day 113, I Feel Fatigued
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
2 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, I Feel Fatigued
|
-3 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, I Feel Fatigued
|
-4 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, I Feel Fatigued
|
3 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, I Feel Fatigued
|
8 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, I Feel Fatigued
|
6 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Week 12, I Feel Fatigued
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
2 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 12, I Feel Fatigued
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-5 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Day 162, I Feel Fatigued
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-4 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Day 91, I Feel Fatigued
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-12 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Day 85, I Feel Fatigued
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-7 Scores on scale
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 8, Day 87, I Feel Fatigued
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-10 Scores on scale
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24Population: ITT-Part B Population
The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=3 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 3, Day 23, I Feel Fatigued
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 4, Week 12, I Feel Fatigued
|
2 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 5, Week 8, I Feel Fatigued
|
-1 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 6, Day 65, I Feel Fatigued
|
-1 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 7, Week 12, I Feel Fatigued
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 8, Day 64, I Feel Fatigued
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-3 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 10, Day 57, I Feel Fatigued
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
13 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 13, Day 59, I Feel Fatigued
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
7 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 17, Week 12, I Feel Fatigued
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
6 Scores on scale
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 17, Day112, I Feel Fatigued
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
6 Scores on scale
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 5, Day 85, I Feel Fatigued
|
-3 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 7, Day 373, I Feel Fatigued
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
5 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 9, Day 29, I Feel Fatigued
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 11, Week 12, I Feel Fatigued
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
5 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 11, Day 163, I Feel Fatigued
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
6 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 12, Day 85, I Feel Fatigued
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-1 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 14, Day 57, I Feel Fatigued
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-11 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 16, Day 169, I Feel Fatigued
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 18, Day 85, I Feel Fatigued
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-1 Scores on scale
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 1, Day 30, I Feel Fatigued
|
-3 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 2, Day 29, I Feel Fatigued
|
-1 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B
Par 4, Day 113, I Feel Fatigued
|
-16 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24Population: ITT-Part B Population
The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain now on an 11-point numeric rating scale ranging from 0, "no pain" to 10, "the worst pain imaginable". Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 2
|
4 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 8
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12
|
1 Scores on scale
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 38
|
1 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 40
|
1 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Day 113
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-2 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Week 8
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Week 12
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-3 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 16
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Day 85
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 8, Week 2
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
2 Scores on scale
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 4
|
-1 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 8
|
-1 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12
|
4 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339
|
-2 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 4
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Week 4
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-2 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 4
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 8
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 12
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 14
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Day 162
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Week 2
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
2 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Week 4
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-2 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Week 8
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-2 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Day 91
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-1 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Week 2
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-1 Scores on scale
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Week 4
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Week 8
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
1 Scores on scale
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 8, Week 4
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 8, Day 87
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24Population: ITT-Part B Population
The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain now on an 11-point numeric rating scale ranging from 0, "no pain" to 10, "the worst pain imaginable". Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=3 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 4, Week 4
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 5, Day 85
|
2 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 8, Day 64
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-1 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 9, Day 29
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 11, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 3, Day 23
|
-1 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 4, Week 8
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 4, Week 12
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 4, Day 113
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 5, Week 4
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 10, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 5, Week 8
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 6, Week 4
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 6, Day 65
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 7, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 7, Week 8
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 7, Week 12
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 7, Day 373
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 8, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 10, Day 57
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-1 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 11, Week 8
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 11, Week 12
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 11, Day 163
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 12, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 12, Week 8
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-1 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 12, Day 85
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 13, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 13, Day 59
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 14, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 14, Day 57
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-1 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 16, Day 169
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-3 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 17, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-2 Scores on scale
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 17, Week 12
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-2 Scores on scale
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 17, Day 112
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-2 Scores on scale
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 18, Week 8
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Scores on scale
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 18, Day 85
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 1, Day 30
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B
Par 2, Day 29
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
SECONDARY outcome
Timeframe: Day 87, 339, 344, Week 12, 24Population: ITT-Part B Population
Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing "no difficulty" (0), "some difficulty" (1), "much difficulty" (2), and "unable to do" (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=1 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Able to Do Chores
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Get On and Off The Toilet
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Get In and Out of a car
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Week 12, Stand Up From a Straight
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Week 12, Dress yourself
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Week 12, Walk Outdoors on Flat Ground
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Day 87, Turn Faucets On And Off
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Day 87, Get On and Off The Toilet
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Day 87, Take a Tub Bath
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Day 87, Wash and Dry Your Body
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
1 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Day 87, Reach-Get Down 5 Lb Obj Above Head
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
1 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Day 87, Climb Up Five Steps
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Lift a Full Cup/Glass to mouth
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Open a New Milk Carton
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Open car doors
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Able to Do Chores
|
1 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Get In and Out of a car
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Run Errands and Shop
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Get In and Out of Bed
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Stand Up From a Straight
|
1 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Dress yourself
|
1 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Shampoo your hair
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Cut your meat
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Lift a Full Cup/Glass to mouth
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Open a New Milk Carton
|
1 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Open car doors
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Open Jars Previously Opened
|
1 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Turn Faucets On And Off
|
1 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Get On and Off The Toilet
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Take a Tub Bath
|
3 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Wash and Dry Your Body
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Bend Down Pick Up Clothing-Floor
|
1 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Reach-Get Down 5 Lb Obj Above Head
|
1 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Climb Up Five Steps
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12, Walk Outdoors on Flat Ground
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Get In and Out of a car
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Run Errands and Shop
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Get In and Out of Bed
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Stand Up From a Straight
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Dress yourself
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Shampoo your hair
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Cut your meat
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Open Jars Previously Opened
|
1 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Turn Faucets On And Off
|
1 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Bend Down Pick Up Clothing-Floor
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Take a Tub Bath
|
3 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Wash and Dry Your Body
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Bend Down Pick Up Clothing-Floor
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Reach-Get Down 5 Lb Obj Above Head
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Climb Up Five Steps
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24, Walk Outdoors on Flat Ground
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Able to Do Chores
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Get In and Out of a car
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Run Errands and Shop
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Get In and Out of Bed
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Stand Up From a Straight
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Dress yourself
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Shampoo your hair
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Cut your meat
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Lift a Full Cup/Glass to mouth
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Open a New Milk Carton
|
1 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Open car doors
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Open Jars Previously Opened
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Turn Faucets On And Off
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Get On and Off The Toilet
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Take a Tub Bath
|
3 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Wash and Dry Your Body
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Reach-Get Down 5 Lb Obj Above Head
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Climb Up Five Steps
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339, Walk Outdoors on Flat Ground
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Able to Do Chores
|
1 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Get In and Out of a car
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Run Errands and Shop
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Get In and Out of Bed
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Stand Up From a Straight
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Dress yourself
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Shampoo your hair
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Cut your meat
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Lift a Full Cup/Glass to mouth
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Open a New Milk Carton
|
1 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Open car doors
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Open Jars Previously Opened
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Turn Faucets On And Off
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Get On and Off The Toilet
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Take a Tub Bath
|
3 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Wash and Dry Your Body
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Bend Down Pick Up Clothing-Floor
|
1 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Reach-Get Down 5 Lb Obj Above Head
|
2 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Climb Up Five Steps
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12, Walk Outdoors on Flat Ground
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Able to Do Chores
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Get In and Out of a car
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Run Errands and Shop
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Get In and Out of Bed
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Stand Up From a Straight
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Dress yourself
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Shampoo your hair
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Cut your meat
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Lift a Full Cup/Glass to mouth
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Open a New Milk Carton
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Open car doors
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Open Jars Previously Opened
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Turn Faucets On And Off
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Get On and Off The Toilet
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Take a Tub Bath
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Wash and Dry Your Body
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Bend Down Pick Up Clothing-Floor
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Reach-Get Down 5 Lb Obj Above Head
|
1 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Climb Up Five Steps
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24, Walk Outdoors on Flat Ground
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Able to Do Chores
|
1 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Run Errands and Shop
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Get In and Out of Bed
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Stand Up From a Straight
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Dress yourself
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Shampoo your hair
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Cut your meat
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Lift a Full Cup/Glass to mouth
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Open a New Milk Carton
|
1 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Open car doors
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344,Open Jars Previously Opened
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Turn Faucets On And Off
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Get On and Off The Toilet
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Take a Tub Bath
|
3 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Wash and Dry Your Body
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Bend Down Pick Up Clothing-Floor
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Reach-Get Down 5 Lb Obj Above Head
|
1 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Climb Up Five Steps
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344, Walk Outdoors on Flat Ground
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Week 12, Able to Do Chores
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Week 12, Get In and Out of a car
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Week 12, Run Errands and Shop
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Week 12, Get In and Out of Bed
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Week 12, Shampoo your hair
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Week 12, Cut your meat
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Week 12, Lift a Full Cup/Glass to mouth
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Week 12, Open a New Milk Carton
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Week 12, Open car doors
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Week 12, Open Jars Previously Opened
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Week 12, Turn Faucets On And Off
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Week 12, Get On and Off The Toilet
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Week 12, Take a Tub Bath
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Week 12, Wash and Dry Your Body
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Week 12, Bend Down Pick Up Clothing-Floor
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Week 12, Reach-Get Down 5 Lb Obj Above Head
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Week 12, Climb Up Five Steps
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
0 Scores on scale
|
—
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Day 87, Able to Do Chores
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
1 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Day 87, Get In and Out of a car
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Day 87, Run Errands and Shop
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Day 87, Get In and Out of Bed
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Day 87, Stand Up From a Straight
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Day 87, Dress yourself
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Day 87, Shampoo your hair
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Day 87, Cut your meat
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Day 87, Lift a Full Cup/Glass to mouth
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Day 87, Open a New Milk Carton
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Day 87, Open Jars Previously Opened
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Day 87, Bend Down Pick Up Clothing-Floor
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Day 87, Walk Outdoors on Flat Ground
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
—
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikum
|
—
|
0 Scores on scale
|
SECONDARY outcome
Timeframe: Day 29, 64, 65, 85, 112, 113, 169, 373 and Week 12Population: ITT-Part B Population
Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing "no difficulty" (0), "some difficulty" (1), "much difficulty" (2), and "unable to do" (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=3 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=2 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=1 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=1 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 169,Shampoo your hair
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 29, Able to Do Chores
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 29, Get In and Out of a car
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 29, Run Errands and Shop
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 29, Get In and Out of Bed
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 29, Shampoo your hair
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 29, Bend Down Pick Up Clothing- Floor
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 113, Turn Faucets On And Off
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 65, Get In and Out of Bed
|
1 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 65, Wash and Dry Your Body
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Get In and Out of a car
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Cut your meat
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Bend Down Pick Up Clothing- Floor
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Climb Up Five Steps
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Walk Outdoors on Flat Ground
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 373, Stand Up From a Straight Chair
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 373, Cut your meat
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 373, Open Jars Previously Opened
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 373, Turn Faucets On And Off
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 373, Get On and Off The Toilet
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 373,Take a Tub Bath
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 373, Wash and Dry Your Body
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 373, Bend Down Pick Up Clothing- Floor
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 373, Walk Outdoors on Flat Ground
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 64, Able to Do Chores
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 64, Get In and Out of a car
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 64, Stand Up From a Straight Chair
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 64, Dress yourself
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 64, Cut your meat
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 64, Lift a Full Cup or Glass to Mouth
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 64, Open a New Milk Carton
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 64, Turn Faucets On And Off
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 64, Climb Up Five Steps
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 85, Get In and Out of Bed
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 85,Shampoo your hair
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 85, Cut your meat
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 85, Open a New Milk Carton
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 85, Get On and Off The Toilet
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 85,Take a Tub Bath
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 85, Wash and Dry Your Body
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 85, Bend Down Pick Up Clothing- Floor
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 85, Reach-Get Down 5 Lb Obj Above Head
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 85, Climb Up Five Steps
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 85, Walk Outdoors on Flat Ground
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 169, Able to Do Chores
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 169, Get In and Out of a car
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 169, Run Errands and Shop
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 169, Get In and Out of Bed
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Week 12, Open Jars Previously Opened
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 112, Take a Tub Bath
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 169, Stand Up From a Straight Chair
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 169, Cut your meat
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 169, Dress yourself
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 169, Lift a Full Cup or Glass to Mouth
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 169, Open a New Milk Carton
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 169, Turn Faucets On And Off
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 169, Wash and Dry Your Body
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 169, Reach-Get Down 5 Lb Obj Above Head
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 169, Climb Up Five Steps
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 169, Walk Outdoors on Flat Ground
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Week 12, Able to Do Chores
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Week 12, Run Errands and Shop
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Week 12, Dress yourself
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Week 12,Shampoo your hair
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 29, Stand Up From a Straight Chair
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 29, Dress yourself
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 29, Cut your meat
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 29, Lift a Full Cup or Glass to Mouth
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 29, Open a New Milk Carton
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 29, Open car doors
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 29, Open Jars Previously Opened
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 29, Turn Faucets On And Off
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 29, Get On and Off The Toilet
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 29, Take a Tub Bath
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 29, Wash and Dry Your Body
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 29, Reach-Get Down 5 Lb Obj Above Head
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 29, Climb Up Five Steps
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Week 12, Turn Faucets On And Off
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 29, Walk Outdoors on Flat Ground
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Week 12, Able to Do Chores
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Week 12, Get In and Out of a car
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Week 12, Run Errands and Shop
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Week 12, Get In and Out of Bed
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Week 12, Stand Up From a Straight Chair
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Week 12, Dress yourself
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Week 12, Shampoo your hair
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Week 12, Cut your meat
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Week 12, Lift a Full Cup or Glass to Mouth
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Week 12, Open a New Milk Carton
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Week 12, Open r car doors
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Week 12, Open Jars Previously Opened
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Week 12, Get On and Off The Toilet
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Week 12, Take a Tub Bath
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Week 12, Wash and Dry Your Body
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Week 12, Bend Down Pick Up Clothing- Floor
|
1 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Week 12, Reach-Get Down 5 Lb Obj Above Head
|
1 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Week 12, Climb Up Five Steps
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Week 12, Walk Outdoors on Flat Ground
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 113, Able to Do Chores
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 113, Get In and Out of a car
|
1 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 113, Run Errands and Shop
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 113, Get In and Out of Bed
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 113, Stand Up From a Straight Chair
|
1 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 113, Dress yourself
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 113, Shampoo your hair
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 113, Cut your meat
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 113, Lift a Full Cup or Glass to Mouth
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 113, Open a New Milk Carton
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 113, Open car doors
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 113, Open Jars Previously Opened
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 65, Stand Up From a Straight Chair
|
1 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 113, Wash and Dry Your Body
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 113, Bend Down Pick Up Clothing- Floor
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 113, Get On and Off The Toilet
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 113, Take a Tub Bath
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 65, Dress yourself
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 65, Shampoo your hair
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 65, Take a Tub Bath
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 65, Cut your meat
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 65, Lift a Full Cup or Glass to Mouth
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 65, Open a New Milk Carton
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 65, Open car doors
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 65, Open Jars Previously Opened
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 65, Turn Faucets On And Off
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 65, Get On and Off The Toilet
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 113, Reach-Get Down 5 Lb Obj Above Head
|
1 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 113, Climb Up Five Steps
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 113, Walk Outdoors on Flat Ground
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 65, Able to Do Chores
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 65, Get In and Out of a car
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 65, Run Errands and Shop
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 65, Bend Down Pick Up Clothing- Floor
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 65, Reach-Get Down 5 Lb Obj Above Head
|
1 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 65, Climb Up Five Steps
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 65, Walk Outdoors on Flat Ground
|
0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Able to Do Chores
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Run Errands and Shop
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Get In and Out of Bed
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Stand Up From a Straight Chair
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Dress yourself
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Shampoo your hair
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Lift a Full Cup or Glass to Mouth
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Open a New Milk Carton
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Open car doors
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Open Jars Previously Opened
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Turn Faucets On And Off
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 373, Run Errands and Shop
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Get On and Off The Toilet
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12,Take a Tub Bath
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Wash and Dry Your Body
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12, Reach-Get Down 5 Lb Obj Above Head
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 373, Able to Do Chores
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 373, Get In and Out of a car
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 373, Get In and Out of Bed
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 373, Dress yourself
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 373, Shampoo your hair
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 373, Lift a Full Cup or Glass to Mouth
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 373, Open a New Milk Carton
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 373, Open car doors
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 373, Reach-Get Down 5 Lb Obj Above Head
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 373, Climb Up Five Steps
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 64, Run Errands and Shop
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 64, Get In and Out of Bed
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 64, Shampoo your hair
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 64, Open car doors
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 64, Open Jars Previously Opened
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 64, Get On and Off The Toilet
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 64,Take a Tub Bath
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 64, Wash and Dry Your Body
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 64, Bend Down Pick Up Clothing- Floor
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 64, Reach-Get Down 5 Lb Obj Above Head
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 64, Walk Outdoors on Flat Ground
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 85 Able to Do Chores
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 85, Get In and Out of a car
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 85, Run Errands and Shop
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 85, Stand Up From a Straight Chair
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 85, Dress yourself
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 85, Lift a Full Cup or Glass to Mouth
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 85, Open car doors
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 85, Open Jars Previously Opened
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 85, Turn Faucets On And Off
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 112, Climb Up Five Steps
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 112, Walk Outdoors on Flat Ground
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Week 12, Cut your meat
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Week 12, Lift a Full Cup or Glass to Mouth
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Week 12, Open a New Milk Carton
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Week 12, Open car doors
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Week 12, Turn Faucets On And Off
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Week 12, Get On and Off The Toilet
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Week 12,Take a Tub Bath
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Week 12, Wash and Dry Your Body
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Week 12, Bend Down Pick Up Clothing- Floor
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Week 12 Reach-Get Down 5 Lb Obj Above Head
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Week 12, Climb Up Five Steps
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Week 12, Walk Outdoors on Flat Ground
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 112, Able to Do Chores
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 112, Get In and Out of a car
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 112, Run Errands and Shop
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 112, Get In and Out of Bed
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 112, Stand Up From a Straight Chair
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 112, Dress yourself
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 112, Shampoo your hair
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 112, Cut your meat
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 112, Lift a Full Cup or Glass to Mout
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 112, Open a New Milk Carton
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 112, Open car doors
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 112, Open Jars Previously Opened
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 112, Turn Faucets On And Off
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 112, Get On and Off The Toilet
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 112, Wash and Dry Your Body
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 112, Bend Down Pick Up Clothing- Floor
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 112, Reach-Get Down 5 Lb Obj Above Head
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Week 12, Get In and Out of a car
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Week 12, Get In and Out of Bed
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Week 12, Stand Up From a Straight Chair
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0 Scores on scale
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 169, Open car doors
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 169, Open Jars Previously Opened
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 169, Get On and Off The Toilet
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 169,Take a Tub Bath
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 169, Bend Down Pick Up Clothing- Floor
|
NA Scores on scale
Only 3 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38, 40; Days 85, 87, 91, , 113, 162, 339, and 344Population: ITT-Part B Population
The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS). of 10 centimeter (cm) ranging from 0 ("very well) to 10 ("very poor"). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 16
|
-0.7 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 8
|
-0.2 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 38
|
0.9 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 40
|
-0.3 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3,Par 3,, Day 113
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
2.1 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Week 4
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-1.0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Week 8
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
4.9 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 4
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
2.0 Scores on scale
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 8
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0.4 Scores on scale
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 12
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0.2 Scores on scale
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 14
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
1.0 Scores on scale
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 16
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
1.0 Scores on scale
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Day 162
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0.8 Scores on scale
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Week 4
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-3.1 Scores on scale
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Week 8
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-3.2 Scores on scale
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Day 91
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-3.5 Scores on scale
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Week 2
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-0.7 Scores on scale
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Week 2
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-0.1 Scores on scale
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344
|
-0.7 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 2
|
4.3 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 4
|
2.3 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12
|
4.0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 16
|
4.7 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24
|
2.2 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 36
|
0.4 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339
|
-0.7 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 4
|
-1.0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 8
|
-0.3 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12
|
-0.6 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24
|
0.5 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 36
|
-0.6 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Week 12
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.4 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Week 4
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0.7 Scores on scale
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Week 8
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0.8 Scores on scale
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Day 85
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-0.4 Scores on scale
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 8, Week 2
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-0.1 Scores on scale
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 8, Week 4
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-3.7 Scores on scale
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 8, Day 87
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-3.1 Scores on scale
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85,112, 113, 115, 163, 169 and 373Population: ITT-Part B Population
The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS). of 10 centimeter (cm) ranging from 0 ("very well) to 10 ("very poor"). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 23
|
0.0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 4
|
-0.2 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Week 4
|
0.1 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1.0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Week 12
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 9, Day 29
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.1 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 10, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 12, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-0.8 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 12, Week 8
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-0.7 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 12, Day 85
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.9 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 13, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-0.7 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 13, Day 59
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1.0 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-0.3 Scores on scale
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 17, Week 8
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
0.2 Scores on scale
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12
|
0.0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 113
|
0.0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 8
|
0.1 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Week 8
|
0.4 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 85
|
2.3 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Week 4
|
-1.0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 65
|
0.5 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Week 8
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Week 16
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.2 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Week 36
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.2 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 373
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.9 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-0.2 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 64
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-0.4 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 10, Day 57
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-0.3 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-0.1 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Week 8
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.2 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 30
|
0.2 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 29
|
-0.1 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Week 12
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.2 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Week 16
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1.2 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Day 163
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.3 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 14, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-0.4 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 14, Day 57
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-0.9 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 15, Day 169
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-1.1 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Week 12
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-0.3 Scores on scale
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Day 112
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-0.1 Scores on scale
|
|
Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 17, Day 85
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-0.1 Scores on scale
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Day 85, Day 113, Day 162, Day 203, Day 339, Day 344, Week 2, Week 4, Week 8, Week 12, Week 14, Week 16, Week 24, Week 36, Week 38, Week 40Population: ITT-Part B Population
In PhGA was based on "What is physician's assessment of the participant's current disease activity". PhGA used a 10 cm VAS ranging from 0 ("none") to 10 ("extremely active"). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 8
|
0.1 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12
|
0.4 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 16
|
0.1 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24
|
0.0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 36
|
0.1 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 38
|
0.7 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 40
|
0.4 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Week 4
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-0.2 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 4
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1.8 Scores on scale
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 8, Week 4
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-6.3 Scores on scale
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344
|
0.2 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Day 113
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-0.2 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 2
|
0.0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 4
|
-0.5 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 8
|
-1.2 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12
|
-0.6 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 16
|
-0.9 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24
|
-0.6 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 36
|
-1.1 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339
|
-1.2 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 4
|
0.0 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Week 12
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.1 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 8
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-1.1 Scores on scale
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 12
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-0.7 Scores on scale
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 14
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1.5 Scores on scale
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 16
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-1.1 Scores on scale
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Day 162
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-0.4 Scores on scale
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Day 203
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
7.6 Scores on scale
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Week 2
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.0 Scores on scale
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Week 4
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.1 Scores on scale
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Week 8
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.0 Scores on scale
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Day 85
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.0 Scores on scale
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 8, Week 2
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-6.0 Scores on scale
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Weeks 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169 and 373Population: ITT-Part B Population. Only those participants with data available at the specified time points were analyzed.
In PhGA was based on "What is physician's assessment of the participant's current disease activity". PhGA used a 10 cm VAS ranging from 0 ("none") to 10 ("extremely active"). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 85
|
0.3 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Week 12
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.2 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 12, Week 8
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.1 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 30
|
0.0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 29
|
0.1 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 23
|
0.0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Week 12
|
0.7 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 113
|
0.0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Week 4
|
-0.3 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Week 4
|
-0.2 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 65
|
-0.3 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.2 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Week 8
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Week 16
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.4 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Week 36
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.2 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 373
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.4 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 64
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.1 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 9, Day 29
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.2 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 10, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.0 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 10, Day 57
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.1 Scores on scale
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Week 12
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.9 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Week 16
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.9 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Day 163
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.4 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 12, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-0.1 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 12, Day 85
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-0.1 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 13, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-0.6 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 13, Day 59
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-0.3 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 14, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-0.3 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 14, Day 57
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.3 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 15, Day 169
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-0.5 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Week 4
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-0.1 Scores on scale
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Week 12
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.0 Scores on scale
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Day 112
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.4 Scores on scale
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 17, Week 8
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.1 Scores on scale
|
|
Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 17, Day 85
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
0.2 Scores on scale
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Days 103 and 271Population: ITT-Part B Population
Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Day 1: Better
|
NA Participants
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
1 Participants
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 1: Much Better
|
1 Participants
|
NA Participants
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 1: Much Better
|
1 Participants
|
NA Participants
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 271: Worse
|
1 Participants
|
NA Participants
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Day 1: Much Better
|
NA Participants
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
1 Participants
|
NA Participants
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Day 1: Much Better
|
NA Participants
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Participants
|
NA Participants
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5,Day 1: Slightly Better
|
NA Participants
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
1 Participants
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Day 103: No change
|
NA Participants
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
1 Participants
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Day 1: Much Better
|
NA Participants
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Participants
|
|
Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 8, Day 1: Slightly Better
|
NA Participants
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 1 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 1 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1)Population: ITT-Part B Population
Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=3 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 1: Much Better
|
NA Participants
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Participants
|
NA Participants
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 1: Better
|
NA Participants
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Participants
|
NA Participants
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
Par 14, Day 1: Better
|
NA Participants
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Participants
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 1: Better
|
1 Participants
|
NA Participants
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 1: Much Better
|
1 Participants
|
NA Participants
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
Par 9, Day 1: Much Better
|
NA Participants
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Participants
|
NA Participants
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
Par 10, Day 1: Better
|
NA Participants
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Participants
|
NA Participants
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Day 1: Much Better
|
NA Participants
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Participants
|
NA Participants
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
Par 12, Day 1: Much Better
|
NA Participants
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Participants
|
NA Participants
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
Par 13, Day 1: Better
|
NA Participants
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Participants
|
NA Participants
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
Par 15, Day 1: Much Better
|
NA Participants
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Participants
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Day 1: Much Better
|
NA Participants
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Participants
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
Par 17, Day 1: Much Better
|
NA Participants
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
1 Participants
|
|
Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
Par 18, Day 1: Much Better
|
NA Participants
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
1 Participants
|
|
Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 1: No change
|
1 Participants
|
NA Participants
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 1: Much Better
|
1 Participants
|
NA Participants
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 1: Much Better
|
1 Participants
|
NA Participants
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 1: Much Better
|
1 Participants
|
NA Participants
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Participants
Only 3 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Participants
Only 2 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40Population: ITT-Part B Population
Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Week 40, n=1,0,0,0,0
|
0.00 Milligram per liter (mg/L)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Week 2, n=1,1,0,1,2
|
0.00 Milligram per liter (mg/L)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
-0.20 Milligram per liter (mg/L)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
—
|
-3.70 Milligram per liter (mg/L)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
-4.20 Milligram per liter (mg/L)
Standard Deviation 2.970
|
|
Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Week 4, n=2,1,1,2,2
|
0.10 Milligram per liter (mg/L)
Standard Deviation 0.000
|
0.10 Milligram per liter (mg/L)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
0.10 Milligram per liter (mg/L)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
-2.35 Milligram per liter (mg/L)
Standard Deviation 1.909
|
-4.20 Milligram per liter (mg/L)
Standard Deviation 2.828
|
|
Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Week 8, n=2,1,1,2,1
|
0.10 Milligram per liter (mg/L)
Standard Deviation 0.000
|
-0.10 Milligram per liter (mg/L)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
0.30 Milligram per liter (mg/L)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
0.55 Milligram per liter (mg/L)
Standard Deviation 6.010
|
-2.10 Milligram per liter (mg/L)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
|
Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Week 12, n=2,1,1,1,0
|
0.10 Milligram per liter (mg/L)
Standard Deviation 0.000
|
-0.10 Milligram per liter (mg/L)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
0.10 Milligram per liter (mg/L)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
3.90 Milligram per liter (mg/L)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
—
|
|
Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Week 14, n=0,0,0,1,0
|
—
|
—
|
—
|
-30.20 Milligram per liter (mg/L)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
—
|
|
Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Week 16, n=2,0,0,1,0
|
0.40 Milligram per liter (mg/L)
Standard Deviation 0.424
|
—
|
—
|
-30.70 Milligram per liter (mg/L)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
—
|
|
Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Week 24, n=2,0,0,0,0
|
1.90 Milligram per liter (mg/L)
Standard Deviation 2.546
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Week 36, n=2,0,0,0,0
|
0.80 Milligram per liter (mg/L)
Standard Deviation 0.849
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Week 38, n=1,0,0,0,0
|
-0.10 Milligram per liter (mg/L)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36Population: ITT-Part B Population
Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=3 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Week 4, n=3,3,2,1,2
|
-0.30 mg/L
Standard Deviation 0.361
|
-0.23 mg/L
Standard Deviation 0.252
|
0.05 mg/L
Standard Deviation 0.071
|
6.10 mg/L
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
-0.55 mg/L
Standard Deviation 1.202
|
|
Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Week 8, n=2,1,2,0,2
|
-0.05 mg/L
Standard Deviation 0.778
|
0.00 mg/L
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
0.00 mg/L
Standard Deviation 0.000
|
—
|
0.95 mg/L
Standard Deviation 0.636
|
|
Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Week 12, n=1,1,1,1,1
|
-0.90 mg/L
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
0.00 mg/L
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
0.00 mg/L
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
-0.80 mg/L
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
0.70 mg/L
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
|
Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Week 16, n=0,1,1,1,0
|
—
|
0.00 mg/L
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
0.00 mg/L
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
-0.70 mg/L
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
—
|
|
Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Week 24, n=0,1,0,0,0
|
—
|
0.00 mg/L
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
—
|
—
|
—
|
|
Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Week 36, n=0,1,0,0,0
|
—
|
0.00 mg/L
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40Population: Safety-Part B Population
Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Week 2, n=1,1,0,1,1
|
-1.0 Millimeter per hour (mm/h)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
4.0 Millimeter per hour (mm/h)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
—
|
-14.0 Millimeter per hour (mm/h)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
-7.0 Millimeter per hour (mm/h)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
|
Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Week 8, n=2,1,0,2,1
|
3.0 Millimeter per hour (mm/h)
Standard Deviation 7.07
|
2.0 Millimeter per hour (mm/h)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
—
|
-6.0 Millimeter per hour (mm/h)
Standard Deviation 15.56
|
-7.0 Millimeter per hour (mm/h)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
|
Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Week 4, n=2,1,1,2,2
|
0.5 Millimeter per hour (mm/h)
Standard Deviation 2.12
|
4.0 Millimeter per hour (mm/h)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
4.0 Millimeter per hour (mm/h)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
-5.0 Millimeter per hour (mm/h)
Standard Deviation 16.97
|
-29.5 Millimeter per hour (mm/h)
Standard Deviation 31.82
|
|
Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Week 12, n=2,1,1,1,0
|
0.0 Millimeter per hour (mm/h)
Standard Deviation 1.41
|
2.0 Millimeter per hour (mm/h)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
4.0 Millimeter per hour (mm/h)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
10.0 Millimeter per hour (mm/h)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant..
|
—
|
|
Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Week 14, n=0,0,0,1,0
|
—
|
—
|
—
|
-19.0 Millimeter per hour (mm/h)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant..
|
—
|
|
Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Week 16, n=2,0,0,1,0
|
-0.5 Millimeter per hour (mm/h)
Standard Deviation 2.12
|
—
|
—
|
-18.0 Millimeter per hour (mm/h)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant..
|
—
|
|
Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Week 24, n=2,0,0,0,0
|
-1.5 Millimeter per hour (mm/h)
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Week 36, n=2,0,0,0,0
|
6.0 Millimeter per hour (mm/h)
Standard Deviation 11.31
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Week 38, n=1,0,0,0,0
|
-1.0 Millimeter per hour (mm/h)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant..
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Week 40, n=1,0,0,0,0
|
1.0 Millimeter per hour (mm/h)
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant..
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36Population: Safety-Part B Population
Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=3 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Week 12, n=1,1,1,1,1
|
-6.0 mm/h
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
1.0 mm/h
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
0.0 mm/h
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
-6.0 mm/h
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
12.0 mm/h
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
|
Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Week 4, n=3,3,3,1,2
|
-1.7 mm/h
Standard Deviation 5.03
|
1.3 mm/h
Standard Deviation 1.53
|
-1.0 mm/h
Standard Deviation 1.00
|
8.0 mm/h
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
-2.0 mm/h
Standard Deviation 5.66
|
|
Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Week 8, n=2,1,3,0,2
|
-1.0 mm/h
Standard Deviation 7.07
|
2.0 mm/h
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
-2.0 mm/h
Standard Deviation 0.00
|
—
|
0.0 mm/h
Standard Deviation 2.83
|
|
Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Week 16, n=0,1,1,1,0
|
—
|
3.0 mm/h
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
1.0 mm/h
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
-4.0 mm/h
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
—
|
|
Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Week 24, n=0,1,0,0,0
|
—
|
1.0 mm/h
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
|
Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Week 36, n=0,1,0,0,0
|
—
|
1.0 mm/h
Standard Deviation NA
NA indicates data is not available since standard deviation could not be calculated for single participant.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Days 85, 87, 91, 113, 162, 339 and 344 and Weeks 12 and 24Population: ITT-Part B Population
EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 6 dimensions: 1.Mobility, 2.Self, 3.Usual Activities, 4.Pain/Discomfort, 5.Anxiety/Depression; 6.How good or or bad your health is today. Each of these 6 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 'Best imaginable health state' and 'Worst imaginable health state'. Answers to 'How good or bad your health is today' were measured on a 100 point VAS scale. Baseline for Part B is the last non-missing measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=2 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=1 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=1 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 12
|
-12 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Week 24
|
1 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 1, Day 339
|
8 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 12
|
3 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Week 24
|
14 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 2, Day 344
|
-1 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 3, Day 113
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
1 Scores on scale
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 4, Week 12
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.v
|
-4 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Week 12
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
9 Scores on scale
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 5, Day 162
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
-15 Scores on scale
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 6, Day 91
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
20 Scores on scale
|
NA Scores on scale
Only 2 participant in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 8, Day 87
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
21 Scores on scale
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B
Par 7, Day 85
|
NA Scores on scale
Only 2 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participant in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
4 Scores on scale
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169, 344 and 373 and Week 12Population: ITT-Part B Population
EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 6 dimensions: 1.Mobility, 2.Self, 3.Usual Activities, 4.Pain/Discomfort, 5.Anxiety/Depression; 6.How good or or bad your health is today. Each of these 6 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 100 (Best imaginable health state) and 0 (Worst imaginable health state). Answers to 'How good or bad your health is today' were measured on a 100 point VAS scale. Baseline for Part B is the last non-missing measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.
Outcome measures
| Measure |
PartA:SIR 100 mg SC q2w+6 Month Prednisone
n=6 Participants
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
PartA:SIR 100 mg SC q2w+3 Month Prednisone
n=4 Participants
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
PartA:SIR 50 mg SC q4w+6 Month Prednisone
n=3 Participants
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 6 Month Prednisone
n=3 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
PartA:Placebo SC q2w + 12 Month Prednisone
n=2 Participants
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
|---|---|---|---|---|---|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 1, Day 30
|
2 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 2, Day 29
|
0 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 3, Day 23
|
1 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Week 12
|
-2 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 4, Day 113
|
-47 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 5, Day 85
|
-1 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 6, Day 65
|
20 Scores on scale
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Week 12
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
4 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 7, Day 373
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
8 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 8, Day 64
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-2 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 9, Day 29
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-1 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 10, Day 57
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
5 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Week 12
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-10 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 11, Day 163
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-12 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 12, Day 85
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-8 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 13, Day 59
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
10 Scores on scale
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 14, Day 57
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-42 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 16, Day 169
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
62 Scores on scale
|
NA Scores on scale
Only 1 participants in Arm5 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 17, Week 12
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
9 Scores on scale
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 17, Day 112
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
7 Scores on scale
|
|
Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B
Par 18, Day 85
|
NA Scores on scale
Only 6 participants in Arm1 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 4 participants in Arm2 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm3 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
NA Scores on scale
Only 2 participants in Arm4 completed Part A of the study, entered Part B and received at least one dose of 100mg OL Sirikumab.
|
-4 Scores on scale
|
Adverse Events
Part A:SIR 100 mg SC q2w+6 Month Prednisone
Serious events: 8 serious events
Other events: 41 other events
Deaths: 0 deaths
Part A:SIR 100 mg SC q2w+3 Month Prednisone
Serious events: 6 serious events
Other events: 36 other events
Deaths: 0 deaths
Part A: SIR 50 mg SC q4w+6 Month Prednisone
Serious events: 6 serious events
Other events: 25 other events
Deaths: 0 deaths
Part A:Placebo SC q2w + 6 Month Prednisone
Serious events: 5 serious events
Other events: 26 other events
Deaths: 0 deaths
Part A:Placebo SC q2w + 12 Month Prednisone
Serious events: 6 serious events
Other events: 24 other events
Deaths: 0 deaths
Part B:SIR 100 mg SC q2w+6 Month Prednisone+100mg OL SIR
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B:SIR 100 mg SC q2w+3 Month Prednisone+100mg OL SIR
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B:SIR 50 mg SC q4w+6 Month Prednisone+100mg OL SIR
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B:Placebo SC q2w + 6 Month Prednisone+100mg OL SIR
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B:Placebo SC q2w + 12 Month Prednisone+100mg OL SIR
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B:SIR 100 mg SC q2w+6 Month Prednisone/ No 100mg OL SIR
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B:SIR 100 mg SC q2w+3 Month Prednisone/ No 100mg OL SIR
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B:SIR 50 mg SC q4w+6 Month Prednisone/ No 100mg OL SIR
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B:Placebo SC q2w + 6 Month Prednisone/ No 100mg OL SIR
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B:Placebo SC q2w + 12 Month Prednisone/ No 100mg OL SIR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A:SIR 100 mg SC q2w+6 Month Prednisone
n=42 participants at risk
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
Part A:SIR 100 mg SC q2w+3 Month Prednisone
n=39 participants at risk
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
Part A: SIR 50 mg SC q4w+6 Month Prednisone
n=26 participants at risk
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
Part A:Placebo SC q2w + 6 Month Prednisone
n=27 participants at risk
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
Part A:Placebo SC q2w + 12 Month Prednisone
n=27 participants at risk
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
Part B:SIR 100 mg SC q2w+6 Month Prednisone+100mg OL SIR
n=2 participants at risk
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.
|
Part B:SIR 100 mg SC q2w+3 Month Prednisone+100mg OL SIR
n=1 participants at risk
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.
|
Part B:SIR 50 mg SC q4w+6 Month Prednisone+100mg OL SIR
n=1 participants at risk
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.
|
Part B:Placebo SC q2w + 6 Month Prednisone+100mg OL SIR
n=2 participants at risk
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.
|
Part B:Placebo SC q2w + 12 Month Prednisone+100mg OL SIR
n=2 participants at risk
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.
|
Part B:SIR 100 mg SC q2w+6 Month Prednisone/ No 100mg OL SIR
n=6 participants at risk
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A. Participants never received 100mg OL SIR in Part B.
|
Part B:SIR 100 mg SC q2w+3 Month Prednisone/ No 100mg OL SIR
n=4 participants at risk
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen. Participants never received 100mg OL SIR in Part B.
|
Part B:SIR 50 mg SC q4w+6 Month Prednisone/ No 100mg OL SIR
n=3 participants at risk
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen. Participants never received 100mg OL SIR in Part B.
|
Part B:Placebo SC q2w + 6 Month Prednisone/ No 100mg OL SIR
n=3 participants at risk
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen. Participants never received 100mg OL SIR in Part B.
|
Part B:Placebo SC q2w + 12 Month Prednisone/ No 100mg OL SIR
n=2 participants at risk
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen. Participants never received 100mg OL SIR in Part B.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Nervous system disorders
Syncope
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.8%
1/26 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Infections and infestations
Escherichia sepsis
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Infections and infestations
Metapneumovirus infection
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.8%
1/26 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.8%
1/26 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.8%
1/26 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
General disorders
Asthenia
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
General disorders
Chest discomfort
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
General disorders
Pyrexia
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity vasculitis
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.8%
1/26 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Vascular disorders
Temporal arteritis
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.8%
1/26 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.8%
1/26 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/36 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
Other adverse events
| Measure |
Part A:SIR 100 mg SC q2w+6 Month Prednisone
n=42 participants at risk
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen
|
Part A:SIR 100 mg SC q2w+3 Month Prednisone
n=39 participants at risk
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen
|
Part A: SIR 50 mg SC q4w+6 Month Prednisone
n=26 participants at risk
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
Part A:Placebo SC q2w + 6 Month Prednisone
n=27 participants at risk
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen
|
Part A:Placebo SC q2w + 12 Month Prednisone
n=27 participants at risk
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen
|
Part B:SIR 100 mg SC q2w+6 Month Prednisone+100mg OL SIR
n=2 participants at risk
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.
|
Part B:SIR 100 mg SC q2w+3 Month Prednisone+100mg OL SIR
n=1 participants at risk
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.
|
Part B:SIR 50 mg SC q4w+6 Month Prednisone+100mg OL SIR
n=1 participants at risk
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.
|
Part B:Placebo SC q2w + 6 Month Prednisone+100mg OL SIR
n=2 participants at risk
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.
|
Part B:Placebo SC q2w + 12 Month Prednisone+100mg OL SIR
n=2 participants at risk
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen in Part A. Participants received at least one dose of 100mg OL SIR in Part B.
|
Part B:SIR 100 mg SC q2w+6 Month Prednisone/ No 100mg OL SIR
n=6 participants at risk
Participants received SIR 100 milligram (mg) subcutaneously (SC) every 2 weeks (q2w) for 52 weeks plus a pre-specified maximum of 6-months prednisone taper regimen in Part A. Participants never received 100mg OL SIR in Part B.
|
Part B:SIR 100 mg SC q2w+3 Month Prednisone/ No 100mg OL SIR
n=4 participants at risk
Participants received SIR 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen. Participants never received 100mg OL SIR in Part B.
|
Part B:SIR 50 mg SC q4w+6 Month Prednisone/ No 100mg OL SIR
n=3 participants at risk
Participants received SIR 50 mg SC every 4 weeks (q4w) for 52 weeks plus a pre-specified maximum of 3-month prednisone taper regimen. Participants never received 100mg OL SIR in Part B.
|
Part B:Placebo SC q2w + 6 Month Prednisone/ No 100mg OL SIR
n=3 participants at risk
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen. Participants never received 100mg OL SIR in Part B.
|
Part B:Placebo SC q2w + 12 Month Prednisone/ No 100mg OL SIR
n=2 participants at risk
Participants received placebo SC q2w for 52 weeks plus a pre-specified maximum of 12-month prednisone taper regimen. Participants never received 100mg OL SIR in Part B.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Sinusitis
|
7.1%
3/42 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
3/39 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
16.7%
1/6 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
16.7%
1/6 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.9%
5/42 • Number of events 7 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
10.3%
4/39 • Number of events 36 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
19.2%
5/26 • Number of events 6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
14.8%
4/27 • Number of events 6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
33.3%
1/3 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
7/42 • Number of events 7 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
3/39 • Number of events 9 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
11.5%
3/26 • Number of events 5 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
14.8%
4/27 • Number of events 5 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.1%
3/42 • Number of events 6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
12.8%
5/39 • Number of events 6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
11.5%
3/26 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
3/39 • Number of events 4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.8%
2/42 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.1%
3/42 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 7 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.8%
1/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
14.8%
4/27 • Number of events 5 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.4%
1/42 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 5 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.8%
1/26 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.8%
2/42 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
3/42 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
11.5%
3/26 • Number of events 5 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
11.1%
3/27 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
7.1%
3/42 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
16.7%
1/6 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Infections and infestations
Bronchitis
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
3/39 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Infections and infestations
Gastroenteritis
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
33.3%
1/3 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
3/42 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
11.5%
3/26 • Number of events 4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
16.7%
1/6 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
33.3%
1/3 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.8%
1/26 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Infections and infestations
Rhinitis
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.8%
2/42 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
20.5%
8/39 • Number of events 8 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
14.8%
4/27 • Number of events 5 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
3/42 • Number of events 4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
14.8%
4/27 • Number of events 10 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Nervous system disorders
Dizziness
|
7.1%
3/42 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
10.3%
4/39 • Number of events 5 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
11.1%
3/27 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Nervous system disorders
Headache
|
31.0%
13/42 • Number of events 20 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
17.9%
7/39 • Number of events 14 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
30.8%
8/26 • Number of events 16 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
25.9%
7/27 • Number of events 7 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
29.6%
8/27 • Number of events 13 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
100.0%
1/1 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
33.3%
1/3 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Nervous system disorders
Hypoaesthesia
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Nervous system disorders
Paraesthesia
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Nervous system disorders
Tremor
|
7.1%
3/42 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
3/39 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.8%
1/26 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
General disorders
Asthenia
|
7.1%
3/42 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.8%
1/26 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
General disorders
Fatigue
|
4.8%
2/42 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
3/39 • Number of events 41 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
15.4%
4/26 • Number of events 5 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
33.3%
1/3 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
General disorders
Injection site erythema
|
21.4%
9/42 • Number of events 29 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
10.3%
4/39 • Number of events 4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 5 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
General disorders
Injection site pain
|
4.8%
2/42 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
3/39 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
General disorders
Injection site pruritus
|
7.1%
3/42 • Number of events 19 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
10.3%
4/39 • Number of events 7 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.8%
1/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
General disorders
Injection site reaction
|
14.3%
6/42 • Number of events 9 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
15.4%
4/26 • Number of events 13 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
General disorders
Injection site swelling
|
9.5%
4/42 • Number of events 6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
10.3%
4/39 • Number of events 4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 8 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
General disorders
Injection site warmth
|
2.4%
1/42 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.8%
1/26 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
General disorders
Oedema peripheral
|
11.9%
5/42 • Number of events 5 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
20.5%
8/39 • Number of events 14 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
11.5%
3/26 • Number of events 4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
General disorders
Pain
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 11 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
11.5%
3/26 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.8%
2/42 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.9%
5/42 • Number of events 5 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
19.2%
5/26 • Number of events 12 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.8%
1/26 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
3/42 • Number of events 4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
33.3%
1/3 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Gastrointestinal disorders
Toothache
|
9.5%
4/42 • Number of events 4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.8%
1/26 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.0%
8/42 • Number of events 8 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
11.1%
3/27 • Number of events 5 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.8%
2/42 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 8 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.8%
1/26 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
3/42 • Number of events 4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.5%
4/42 • Number of events 4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
15.4%
4/26 • Number of events 4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
3/42 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.9%
5/42 • Number of events 5 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 5 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.8%
1/26 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
4.8%
2/42 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.1%
3/42 • Number of events 4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Injury, poisoning and procedural complications
Fall
|
9.5%
4/42 • Number of events 8 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
11.1%
3/27 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Injury, poisoning and procedural complications
Limb injury
|
9.5%
4/42 • Number of events 5 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Eye disorders
Blepharitis
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Eye disorders
Cataract
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.8%
1/26 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Eye disorders
Eye pain
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.8%
1/26 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Psychiatric disorders
Insomnia
|
7.1%
3/42 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Vascular disorders
Hypertension
|
9.5%
4/42 • Number of events 5 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
15.4%
4/26 • Number of events 4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
25.0%
1/4 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Investigations
C-reactive protein abnormal
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Investigations
Low density lipoprotein increased
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
16.7%
1/6 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Investigations
Platelet count decreased
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
10.3%
4/39 • Number of events 5 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.8%
1/26 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
2.6%
1/39 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Endocrine disorders
Cushingoid
|
2.4%
1/42 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
5.1%
2/39 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
3.7%
1/27 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
—
0/0 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
—
0/0 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
—
0/0 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
—
0/0 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
—
0/0 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
100.0%
1/1 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
100.0%
1/1 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
100.0%
1/1 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
100.0%
1/1 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
16.7%
1/6 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Eye disorders
Chalazion
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
50.0%
1/2 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
25.0%
1/4 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
25.0%
1/4 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
33.3%
1/3 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Nervous system disorders
Syncope
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
16.7%
1/6 • Number of events 1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.7%
2/26 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/42 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/39 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/26 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/27 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
7.4%
2/27 • Number of events 2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/1 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/6 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/4 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/3 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
0.00%
0/2 • On-treatment serious Adverse events (SAEs) and non-serious Adverse Events (nSAEs) were collected from the start of study treatment up to Week 52 in Part A and up to Week 120 in Part B.
Safety Set was used. Safety Population comprised of all randomized participants who received at least 1 dose of SC Investigational Product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER