Trial Outcomes & Findings for A Study to Evaluate Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to DMARDs (NCT NCT02308163)
NCT ID: NCT02308163
Last Updated: 2024-10-28
Results Overview
The ACR20 response required that all criteria from (1) to (3) below be met. 1. Tender joint count (TJC) : ≥ 20% reduction compared with baseline. 2. Swollen joint count (SJC) : ≥ 20% reduction compared with baseline. 3. ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline (3) ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, Subject's Global Assessment of Arthritis (SGA), Physician's Global Assessment of Arthritis (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), C-Reactive Protein (CRP).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
509 participants
Primary outcome timeframe
Baseline and Week 12/early termination (ET)
Results posted on
2024-10-28
Participant Flow
Participants with rheumatoid arthritis (RA) who had an inadequate response to disease-modifying antirheumatic drugs (DMARDs) were enrolled in 142 sites in Japan, 11 sites in Korea and 12 sites in Taiwan.
Participants were randomized in a 1:1:1:2 ratio to peficitinib 100 mg, 150 mg, placebo or etanercept groups at baseline. At week 12, participants in the placebo group were switched to receive either peficitinib at a dose of 100 mg or 150 mg. The dose of peficitinib administered to the placebo group from week 12 was determined in advance randomly.
Participant milestones
| Measure |
Peficitinib 100 mg
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Placebo / Peficitinib 100 mg
Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52.
|
Placebo / Peficitinib 150 mg
Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 150 mg/day from week 12 to week 52.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
104
|
102
|
50
|
52
|
201
|
|
Overall Study
COMPLETED
|
73
|
84
|
36
|
39
|
167
|
|
Overall Study
NOT COMPLETED
|
31
|
18
|
14
|
13
|
34
|
Reasons for withdrawal
| Measure |
Peficitinib 100 mg
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Placebo / Peficitinib 100 mg
Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52.
|
Placebo / Peficitinib 150 mg
Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 150 mg/day from week 12 to week 52.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Not fulfill eligible criteria
|
1
|
2
|
0
|
1
|
1
|
|
Overall Study
Adverse Event
|
9
|
5
|
2
|
2
|
11
|
|
Overall Study
Lack of Efficacy
|
11
|
3
|
8
|
4
|
6
|
|
Overall Study
Withdrawal of consent
|
2
|
3
|
0
|
2
|
6
|
|
Overall Study
Protocol Violation
|
3
|
3
|
3
|
2
|
5
|
|
Overall Study
Lab data met discontinuation criteria
|
3
|
0
|
0
|
2
|
0
|
|
Overall Study
Miscellaneous
|
2
|
2
|
1
|
0
|
5
|
Baseline Characteristics
The full analysis set (FAS) consisted of all participants who were randomized and received at least 1 dose of the study drug or reference drug.
Baseline characteristics by cohort
| Measure |
Peficitinib 100 mg
n=104 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=102 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Placebo
n=101 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Total
n=507 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.1 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
55 Years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
55.5 Years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
56.3 Years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
55.3 Years
STANDARD_DEVIATION 12 • n=21 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
366 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
141 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
104 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
507 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Tender Joint Count (68 Joints)
|
15 tender joints
STANDARD_DEVIATION 9.4 • n=5 Participants • The full analysis set (FAS) consisted of all participants who were randomized and received at least 1 dose of the study drug or reference drug.
|
15.4 tender joints
STANDARD_DEVIATION 9.5 • n=7 Participants • The full analysis set (FAS) consisted of all participants who were randomized and received at least 1 dose of the study drug or reference drug.
|
14.9 tender joints
STANDARD_DEVIATION 9.3 • n=5 Participants • The full analysis set (FAS) consisted of all participants who were randomized and received at least 1 dose of the study drug or reference drug.
|
16.2 tender joints
STANDARD_DEVIATION 10.7 • n=4 Participants • The full analysis set (FAS) consisted of all participants who were randomized and received at least 1 dose of the study drug or reference drug.
|
15.3 tender joints
STANDARD_DEVIATION 9.6 • n=21 Participants • The full analysis set (FAS) consisted of all participants who were randomized and received at least 1 dose of the study drug or reference drug.
|
|
Swollen Joint Count (66 Joints)
|
12.4 swollen joints
STANDARD_DEVIATION 6.3 • n=5 Participants • FAS
|
12.8 swollen joints
STANDARD_DEVIATION 7.1 • n=7 Participants • FAS
|
11.9 swollen joints
STANDARD_DEVIATION 6.8 • n=5 Participants • FAS
|
12.9 swollen joints
STANDARD_DEVIATION 7.2 • n=4 Participants • FAS
|
12.4 swollen joints
STANDARD_DEVIATION 6.8 • n=21 Participants • FAS
|
|
Subject's Global Assessment of Arthritis Pain
|
57.31 units on a scale
STANDARD_DEVIATION 26.71 • n=5 Participants • FAS
|
58.02 units on a scale
STANDARD_DEVIATION 25.66 • n=7 Participants • FAS
|
55.79 units on a scale
STANDARD_DEVIATION 26.54 • n=5 Participants • FAS
|
57.56 units on a scale
STANDARD_DEVIATION 25.07 • n=4 Participants • FAS
|
56.9 units on a scale
STANDARD_DEVIATION 26.05 • n=21 Participants • FAS
|
|
Subject's Global Assessment of Arthritis
|
57.54 units on a scale
STANDARD_DEVIATION 24.78 • n=5 Participants • FAS
|
59.52 units on a scale
STANDARD_DEVIATION 25.73 • n=7 Participants • FAS
|
57.52 units on a scale
STANDARD_DEVIATION 26.92 • n=5 Participants • FAS
|
58.99 units on a scale
STANDARD_DEVIATION 25.7 • n=4 Participants • FAS
|
58.22 units on a scale
STANDARD_DEVIATION 25.95 • n=21 Participants • FAS
|
|
Physician's Global Assessment of Arthritis
|
60.21 units on a scale
STANDARD_DEVIATION 20.11 • n=5 Participants • FAS
|
58.46 units on a scale
STANDARD_DEVIATION 19.35 • n=7 Participants • FAS
|
58.17 units on a scale
STANDARD_DEVIATION 19.87 • n=5 Participants • FAS
|
61.93 units on a scale
STANDARD_DEVIATION 19.35 • n=4 Participants • FAS
|
59.39 units on a scale
STANDARD_DEVIATION 19.71 • n=21 Participants • FAS
|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI)
|
0.92 units on a scale
STANDARD_DEVIATION 0.69 • n=5 Participants • FAS
|
1.03 units on a scale
STANDARD_DEVIATION 0.67 • n=7 Participants • FAS
|
1.03 units on a scale
STANDARD_DEVIATION 0.75 • n=5 Participants • FAS
|
1 units on a scale
STANDARD_DEVIATION 0.66 • n=4 Participants • FAS
|
1 units on a scale
STANDARD_DEVIATION 0.7 • n=21 Participants • FAS
|
|
C-Reactive Protein (CRP)
|
2.296 mg/dL
STANDARD_DEVIATION 2.566 • n=5 Participants • FAS
|
2.561 mg/dL
STANDARD_DEVIATION 2.597 • n=7 Participants • FAS
|
2.055 mg/dL
STANDARD_DEVIATION 2.144 • n=5 Participants • FAS
|
2.258 mg/dL
STANDARD_DEVIATION 2.224 • n=4 Participants • FAS
|
2.247 mg/dL
STANDARD_DEVIATION 2.346 • n=21 Participants • FAS
|
|
Erythrocyte Sedimentation Rate (ESR)
|
49.6 mm/h
STANDARD_DEVIATION 27.4 • n=5 Participants • FAS
|
50.6 mm/h
STANDARD_DEVIATION 29.7 • n=7 Participants • FAS
|
47.4 mm/h
STANDARD_DEVIATION 29.8 • n=5 Participants • FAS
|
47.9 mm/h
STANDARD_DEVIATION 27.6 • n=4 Participants • FAS
|
48.6 mm/h
STANDARD_DEVIATION 28.8 • n=21 Participants • FAS
|
|
Prior Biologic Disease-modifying Antirheumatic Drug-inadequate Response (DMARD-IR)
No
|
95 Participants
n=5 Participants • FAS
|
95 Participants
n=7 Participants • FAS
|
185 Participants
n=5 Participants • FAS
|
96 Participants
n=4 Participants • FAS
|
471 Participants
n=21 Participants • FAS
|
|
Prior Biologic Disease-modifying Antirheumatic Drug-inadequate Response (DMARD-IR)
Yes
|
9 Participants
n=5 Participants • FAS
|
7 Participants
n=7 Participants • FAS
|
15 Participants
n=5 Participants • FAS
|
5 Participants
n=4 Participants • FAS
|
36 Participants
n=21 Participants • FAS
|
|
Concomitant DMARD at Baseline
No
|
13 Participants
n=5 Participants • FAS
|
13 Participants
n=7 Participants • FAS
|
24 Participants
n=5 Participants • FAS
|
14 Participants
n=4 Participants • FAS
|
64 Participants
n=21 Participants • FAS
|
|
Concomitant DMARD at Baseline
Yes
|
91 Participants
n=5 Participants • FAS
|
89 Participants
n=7 Participants • FAS
|
176 Participants
n=5 Participants • FAS
|
87 Participants
n=4 Participants • FAS
|
443 Participants
n=21 Participants • FAS
|
|
Study Region
Japan
|
85 Participants
n=5 Participants • FAS
|
83 Participants
n=7 Participants • FAS
|
164 Participants
n=5 Participants • FAS
|
83 Participants
n=4 Participants • FAS
|
415 Participants
n=21 Participants • FAS
|
|
Study Region
Korea
|
11 Participants
n=5 Participants • FAS
|
11 Participants
n=7 Participants • FAS
|
22 Participants
n=5 Participants • FAS
|
10 Participants
n=4 Participants • FAS
|
54 Participants
n=21 Participants • FAS
|
|
Study Region
Taiwan
|
8 Participants
n=5 Participants • FAS
|
8 Participants
n=7 Participants • FAS
|
14 Participants
n=5 Participants • FAS
|
8 Participants
n=4 Participants • FAS
|
38 Participants
n=21 Participants • FAS
|
PRIMARY outcome
Timeframe: Baseline and Week 12/early termination (ET)Population: The analysis population consisted of the Full Analysis Set (FAS). Last observation carried forward (LOCF) was used.
The ACR20 response required that all criteria from (1) to (3) below be met. 1. Tender joint count (TJC) : ≥ 20% reduction compared with baseline. 2. Swollen joint count (SJC) : ≥ 20% reduction compared with baseline. 3. ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline (3) ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, Subject's Global Assessment of Arthritis (SGA), Physician's Global Assessment of Arthritis (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), C-Reactive Protein (CRP).
Outcome measures
| Measure |
Placebo
n=101 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=104 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=102 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12
|
30.7 Percentage of Participants
|
57.7 Percentage of Participants
|
74.5 Percentage of Participants
|
83.5 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
The ACR20 response required that all criteria from (1) to (3) below be met. 1. TJC : ≥ 20% reduction compared with baseline. 2. SJC : ≥ 20% reduction compared with baseline. 3. ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With an ACR20-CRP Response Through Week 52
Week 4
|
43.9 Percentage of Participants
|
45.0 Percentage of Participants
|
21.4 Percentage of Participants
|
19.1 Percentage of Participants
|
61.0 Percentage of Participants
|
|
Percentage of Participants With an ACR20-CRP Response Through Week 52
Week 8
|
51.0 Percentage of Participants
|
68.7 Percentage of Participants
|
38.1 Percentage of Participants
|
25.5 Percentage of Participants
|
80.5 Percentage of Participants
|
|
Percentage of Participants With an ACR20-CRP Response Through Week 52
Week 12
|
59.4 Percentage of Participants
|
77.2 Percentage of Participants
|
31.7 Percentage of Participants
|
34.0 Percentage of Participants
|
84.8 Percentage of Participants
|
|
Percentage of Participants With an ACR20-CRP Response Through Week 52
Week 16
|
64.5 Percentage of Participants
|
79.6 Percentage of Participants
|
58.5 Percentage of Participants
|
61.7 Percentage of Participants
|
86.7 Percentage of Participants
|
|
Percentage of Participants With an ACR20-CRP Response Through Week 52
Week 20
|
64.1 Percentage of Participants
|
81.5 Percentage of Participants
|
51.2 Percentage of Participants
|
71.7 Percentage of Participants
|
88.5 Percentage of Participants
|
|
Percentage of Participants With an ACR20-CRP Response Through Week 52
Week 24
|
63.2 Percentage of Participants
|
85.6 Percentage of Participants
|
61.5 Percentage of Participants
|
71.1 Percentage of Participants
|
90.1 Percentage of Participants
|
|
Percentage of Participants With an ACR20-CRP Response Through Week 52
Week 28
|
72.3 Percentage of Participants
|
87.6 Percentage of Participants
|
60.0 Percentage of Participants
|
67.4 Percentage of Participants
|
92.7 Percentage of Participants
|
|
Percentage of Participants With an ACR20-CRP Response Through Week 52
Week 32
|
76.5 Percentage of Participants
|
88.4 Percentage of Participants
|
63.9 Percentage of Participants
|
73.3 Percentage of Participants
|
88.1 Percentage of Participants
|
|
Percentage of Participants With an ACR20-CRP Response Through Week 52
Week 36
|
72.2 Percentage of Participants
|
90.7 Percentage of Participants
|
66.7 Percentage of Participants
|
76.7 Percentage of Participants
|
92.0 Percentage of Participants
|
|
Percentage of Participants With an ACR20-CRP Response Through Week 52
Week 40
|
73.7 Percentage of Participants
|
90.7 Percentage of Participants
|
67.6 Percentage of Participants
|
83.3 Percentage of Participants
|
92.5 Percentage of Participants
|
|
Percentage of Participants With an ACR20-CRP Response Through Week 52
Week 44
|
74.7 Percentage of Participants
|
88.2 Percentage of Participants
|
79.4 Percentage of Participants
|
84.6 Percentage of Participants
|
91.2 Percentage of Participants
|
|
Percentage of Participants With an ACR20-CRP Response Through Week 52
Week 48
|
74.3 Percentage of Participants
|
90.5 Percentage of Participants
|
73.5 Percentage of Participants
|
82.1 Percentage of Participants
|
90.5 Percentage of Participants
|
|
Percentage of Participants With an ACR20-CRP Response Through Week 52
Week 52
|
73.2 Percentage of Participants
|
90.1 Percentage of Participants
|
79.4 Percentage of Participants
|
81.6 Percentage of Participants
|
90.7 Percentage of Participants
|
|
Percentage of Participants With an ACR20-CRP Response Through Week 52
End of Treatment (EOT)
|
65.4 Percentage of Participants
|
84.3 Percentage of Participants
|
67.4 Percentage of Participants
|
74.5 Percentage of Participants
|
86.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12/ETPopulation: FAS. LOCF was used.
The ACR50 response required that all criteria from (1) to (3) below be met. 1. TJC : ≥ 50% reduction compared with baseline. 2. SJC : ≥ 50% reduction compared with baseline. 3. ≥ 50% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP.
Outcome measures
| Measure |
Placebo
n=101 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=104 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=102 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50)-CRP Response at Week 12
|
8.9 Percentage of Participants
|
30.8 Percentage of Participants
|
42.2 Percentage of Participants
|
52.5 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
The ACR50 response required that all criteria from (1) to (3) below be met. 1. TJC : ≥ 50% reduction compared with baseline. 2. SJC : ≥ 50% reduction compared with baseline. 3. ≥ 50% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With an ACR50-CRP Response Through Week 52
EOT
|
43.3 Percentage of Participants
|
66.7 Percentage of Participants
|
41.9 Percentage of Participants
|
55.3 Percentage of Participants
|
69.0 Percentage of Participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 52
Week 4
|
8.2 Percentage of Participants
|
14.0 Percentage of Participants
|
4.8 Percentage of Participants
|
2.1 Percentage of Participants
|
29.5 Percentage of Participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 52
Week 8
|
25.0 Percentage of Participants
|
35.4 Percentage of Participants
|
4.8 Percentage of Participants
|
6.4 Percentage of Participants
|
47.2 Percentage of Participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 52
Week 12
|
32.3 Percentage of Participants
|
45.7 Percentage of Participants
|
7.3 Percentage of Participants
|
12.8 Percentage of Participants
|
55.0 Percentage of Participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 52
Week 16
|
43.0 Percentage of Participants
|
45.2 Percentage of Participants
|
31.7 Percentage of Participants
|
25.5 Percentage of Participants
|
60.6 Percentage of Participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 52
Week 20
|
41.3 Percentage of Participants
|
54.3 Percentage of Participants
|
22.0 Percentage of Participants
|
43.5 Percentage of Participants
|
66.5 Percentage of Participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 52
Week 24
|
43.7 Percentage of Participants
|
62.2 Percentage of Participants
|
38.5 Percentage of Participants
|
44.4 Percentage of Participants
|
64.8 Percentage of Participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 52
Week 28
|
44.6 Percentage of Participants
|
60.7 Percentage of Participants
|
40.0 Percentage of Participants
|
50.0 Percentage of Participants
|
69.5 Percentage of Participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 52
Week 32
|
50.6 Percentage of Participants
|
65.1 Percentage of Participants
|
52.8 Percentage of Participants
|
44.4 Percentage of Participants
|
70.5 Percentage of Participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 52
Week 36
|
53.2 Percentage of Participants
|
68.6 Percentage of Participants
|
47.2 Percentage of Participants
|
44.2 Percentage of Participants
|
70.3 Percentage of Participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 52
Week 40
|
47.4 Percentage of Participants
|
69.8 Percentage of Participants
|
45.9 Percentage of Participants
|
52.4 Percentage of Participants
|
73.4 Percentage of Participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 52
Week 44
|
50.7 Percentage of Participants
|
69.4 Percentage of Participants
|
50.0 Percentage of Participants
|
53.8 Percentage of Participants
|
70.2 Percentage of Participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 52
Week 48
|
48.6 Percentage of Participants
|
73.8 Percentage of Participants
|
58.8 Percentage of Participants
|
69.2 Percentage of Participants
|
75.6 Percentage of Participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 52
Week 52
|
49.3 Percentage of Participants
|
75.3 Percentage of Participants
|
47.1 Percentage of Participants
|
65.8 Percentage of Participants
|
77.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12/ETPopulation: FAS. LOCF was used.
The ACR70 response required that all criteria from (1) to (3) below be met. 1. TJC : ≥ 70% reduction compared with baseline. 2. SJC : ≥ 70% reduction compared with baseline. 3. ≥ 70% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP.
Outcome measures
| Measure |
Placebo
n=101 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=104 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=102 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70)-CRP Response at Week 12
|
1.0 Percentage of Participants
|
13.5 Percentage of Participants
|
27.5 Percentage of Participants
|
30.5 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
The ACR70 response required that all criteria from (1) to (3) below be met. 1. TJC : ≥ 70% reduction compared with baseline. 2. SJC : ≥ 70% reduction compared with baseline. 3. ≥ 70% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With an ACR70-CRP Response Through Week 52
Week 32
|
28.4 Percentage of Participants
|
39.5 Percentage of Participants
|
25.0 Percentage of Participants
|
24.4 Percentage of Participants
|
47.7 Percentage of Participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 52
Week 48
|
33.8 Percentage of Participants
|
51.2 Percentage of Participants
|
32.4 Percentage of Participants
|
38.5 Percentage of Participants
|
54.2 Percentage of Participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 52
Week 4
|
1.0 Percentage of Participants
|
2.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
14.5 Percentage of Participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 52
Week 8
|
11.5 Percentage of Participants
|
14.1 Percentage of Participants
|
0.0 Percentage of Participants
|
2.1 Percentage of Participants
|
20.5 Percentage of Participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 52
Week 12
|
14.6 Percentage of Participants
|
29.3 Percentage of Participants
|
0.0 Percentage of Participants
|
2.1 Percentage of Participants
|
31.9 Percentage of Participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 52
Week 16
|
23.7 Percentage of Participants
|
28.0 Percentage of Participants
|
7.3 Percentage of Participants
|
8.5 Percentage of Participants
|
37.8 Percentage of Participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 52
Week 20
|
26.1 Percentage of Participants
|
30.4 Percentage of Participants
|
7.3 Percentage of Participants
|
19.6 Percentage of Participants
|
41.8 Percentage of Participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 52
Week 24
|
28.7 Percentage of Participants
|
40.0 Percentage of Participants
|
15.4 Percentage of Participants
|
22.2 Percentage of Participants
|
44.5 Percentage of Participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 52
Week 28
|
25.3 Percentage of Participants
|
38.2 Percentage of Participants
|
20.0 Percentage of Participants
|
17.4 Percentage of Participants
|
48.0 Percentage of Participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 52
Week 36
|
31.6 Percentage of Participants
|
43.0 Percentage of Participants
|
27.8 Percentage of Participants
|
18.6 Percentage of Participants
|
44.6 Percentage of Participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 52
Week 40
|
28.9 Percentage of Participants
|
47.7 Percentage of Participants
|
27.0 Percentage of Participants
|
35.7 Percentage of Participants
|
49.7 Percentage of Participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 52
Week 44
|
30.7 Percentage of Participants
|
49.4 Percentage of Participants
|
41.2 Percentage of Participants
|
28.2 Percentage of Participants
|
52.0 Percentage of Participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 52
Week 52
|
35.2 Percentage of Participants
|
48.1 Percentage of Participants
|
38.2 Percentage of Participants
|
42.1 Percentage of Participants
|
56.2 Percentage of Participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 52
EOT
|
31.7 Percentage of Participants
|
42.2 Percentage of Participants
|
34.9 Percentage of Participants
|
34.0 Percentage of Participants
|
48.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity.
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=101 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12
|
-0.64 Units on a Scale
Standard Deviation 1.20
|
-1.62 Units on a Scale
Standard Deviation 1.41
|
-2.17 Units on a Scale
Standard Deviation 1.14
|
-2.42 Units on a Scale
Standard Deviation 1.11
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline DAS28-CRP Through Week 52
Week 4
|
-1.11 Units on a Scale
Standard Deviation 0.97
|
-1.29 Units on a Scale
Standard Deviation 0.83
|
-0.49 Units on a Scale
Standard Deviation 0.78
|
-0.56 Units on a Scale
Standard Deviation 0.86
|
-1.89 Units on a Scale
Standard Deviation 1.05
|
|
Change From Baseline DAS28-CRP Through Week 52
Week 8
|
-1.48 Units on a Scale
Standard Deviation 1.24
|
-1.92 Units on a Scale
Standard Deviation 0.96
|
-0.70 Units on a Scale
Standard Deviation 1.02
|
-0.65 Units on a Scale
Standard Deviation 1.00
|
-2.27 Units on a Scale
Standard Deviation 1.03
|
|
Change From Baseline DAS28-CRP Through Week 52
Week 12
|
-1.66 Units on a Scale
Standard Deviation 1.34
|
-2.27 Units on a Scale
Standard Deviation 1.12
|
-0.70 Units on a Scale
Standard Deviation 1.23
|
-0.82 Units on a Scale
Standard Deviation 1.15
|
-2.49 Units on a Scale
Standard Deviation 1.06
|
|
Change From Baseline DAS28-CRP Through Week 52
Week 16
|
-1.96 Units on a Scale
Standard Deviation 1.37
|
-2.40 Units on a Scale
Standard Deviation 1.26
|
-1.60 Units on a Scale
Standard Deviation 1.29
|
-1.92 Units on a Scale
Standard Deviation 1.25
|
-2.61 Units on a Scale
Standard Deviation 1.01
|
|
Change From Baseline DAS28-CRP Through Week 52
Week 20
|
-2.01 Units on a Scale
Standard Deviation 1.41
|
-2.57 Units on a Scale
Standard Deviation 1.20
|
-1.58 Units on a Scale
Standard Deviation 1.42
|
-2.15 Units on a Scale
Standard Deviation 1.22
|
-2.73 Units on a Scale
Standard Deviation 1.04
|
|
Change From Baseline DAS28-CRP Through Week 52
Week 24
|
-2.06 Units on a Scale
Standard Deviation 1.39
|
-2.68 Units on a Scale
Standard Deviation 1.24
|
-1.60 Units on a Scale
Standard Deviation 1.34
|
-2.28 Units on a Scale
Standard Deviation 1.30
|
-2.79 Units on a Scale
Standard Deviation 1.04
|
|
Change From Baseline DAS28-CRP Through Week 52
Week 28
|
-2.12 Units on a Scale
Standard Deviation 1.37
|
-2.80 Units on a Scale
Standard Deviation 1.27
|
-1.90 Units on a Scale
Standard Deviation 1.50
|
-2.35 Units on a Scale
Standard Deviation 1.31
|
-2.90 Units on a Scale
Standard Deviation 0.97
|
|
Change From Baseline DAS28-CRP Through Week 52
Week 32
|
-2.26 Units on a Scale
Standard Deviation 1.30
|
-2.77 Units on a Scale
Standard Deviation 1.29
|
-1.98 Units on a Scale
Standard Deviation 1.47
|
-2.22 Units on a Scale
Standard Deviation 1.35
|
-2.94 Units on a Scale
Standard Deviation 1.05
|
|
Change From Baseline DAS28-CRP Through Week 52
Week 36
|
-2.31 Units on a Scale
Standard Deviation 1.34
|
-2.87 Units on a Scale
Standard Deviation 1.22
|
-2.21 Units on a Scale
Standard Deviation 1.40
|
-2.26 Units on a Scale
Standard Deviation 1.35
|
-2.91 Units on a Scale
Standard Deviation 1.03
|
|
Change From Baseline DAS28-CRP Through Week 52
Week 40
|
-2.31 Units on a Scale
Standard Deviation 1.36
|
-2.88 Units on a Scale
Standard Deviation 1.27
|
-2.17 Units on a Scale
Standard Deviation 1.46
|
-2.47 Units on a Scale
Standard Deviation 1.48
|
-2.99 Units on a Scale
Standard Deviation 0.97
|
|
Change From Baseline DAS28-CRP Through Week 52
Week 44
|
-2.34 Units on a Scale
Standard Deviation 1.29
|
-2.86 Units on a Scale
Standard Deviation 1.37
|
-2.39 Units on a Scale
Standard Deviation 1.35
|
-2.47 Units on a Scale
Standard Deviation 1.42
|
-2.97 Units on a Scale
Standard Deviation 0.95
|
|
Change From Baseline DAS28-CRP Through Week 52
Week 48
|
-2.26 Units on a Scale
Standard Deviation 1.31
|
-2.98 Units on a Scale
Standard Deviation 1.27
|
-2.58 Units on a Scale
Standard Deviation 1.32
|
-2.73 Units on a Scale
Standard Deviation 1.29
|
-3.03 Units on a Scale
Standard Deviation 1.01
|
|
Change From Baseline DAS28-CRP Through Week 52
Week 52
|
-2.28 Units on a Scale
Standard Deviation 1.38
|
-2.99 Units on a Scale
Standard Deviation 1.26
|
-2.51 Units on a Scale
Standard Deviation 1.29
|
-2.73 Units on a Scale
Standard Deviation 1.30
|
-3.04 Units on a Scale
Standard Deviation 1.08
|
|
Change From Baseline DAS28-CRP Through Week 52
EOT
|
-2.01 Units on a Scale
Standard Deviation 1.63
|
-2.75 Units on a Scale
Standard Deviation 1.36
|
-2.11 Units on a Scale
Standard Deviation 1.59
|
-2.50 Units on a Scale
Standard Deviation 1.41
|
-2.80 Units on a Scale
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: Baseline and Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity.
Outcome measures
| Measure |
Placebo
n=98 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=198 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (ESR) at Week 12
|
-0.62 Units on a Scale
Standard Deviation 1.17
|
-1.60 Units on a Scale
Standard Deviation 1.39
|
-2.24 Units on a Scale
Standard Deviation 1.23
|
-2.51 Units on a Scale
Standard Deviation 1.27
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in DAS28-ESR Through Week 52
Week 4
|
-1.13 Units on a Scale
Standard Deviation 0.94
|
-1.26 Units on a Scale
Standard Deviation 0.84
|
-0.46 Units on a Scale
Standard Deviation 0.74
|
-0.63 Units on a Scale
Standard Deviation 0.87
|
-1.90 Units on a Scale
Standard Deviation 1.12
|
|
Change From Baseline in DAS28-ESR Through Week 52
Week 8
|
-1.50 Units on a Scale
Standard Deviation 1.20
|
-1.96 Units on a Scale
Standard Deviation 1.04
|
-0.68 Units on a Scale
Standard Deviation 0.99
|
-0.57 Units on a Scale
Standard Deviation 0.92
|
-2.33 Units on a Scale
Standard Deviation 1.12
|
|
Change From Baseline in DAS28-ESR Through Week 52
Week 12
|
-1.65 Units on a Scale
Standard Deviation 1.33
|
-2.35 Units on a Scale
Standard Deviation 1.21
|
-0.66 Units on a Scale
Standard Deviation 1.18
|
-0.80 Units on a Scale
Standard Deviation 1.13
|
-2.58 Units on a Scale
Standard Deviation 1.22
|
|
Change From Baseline in DAS28-ESR Through Week 52
Week 16
|
-1.95 Units on a Scale
Standard Deviation 1.40
|
-2.50 Units on a Scale
Standard Deviation 1.36
|
-1.53 Units on a Scale
Standard Deviation 1.33
|
-1.84 Units on a Scale
Standard Deviation 1.20
|
-2.68 Units on a Scale
Standard Deviation 1.15
|
|
Change From Baseline in DAS28-ESR Through Week 52
Week 20
|
-2.06 Units on a Scale
Standard Deviation 1.44
|
-2.65 Units on a Scale
Standard Deviation 1.29
|
-1.57 Units on a Scale
Standard Deviation 1.43
|
-2.15 Units on a Scale
Standard Deviation 1.20
|
-2.76 Units on a Scale
Standard Deviation 1.15
|
|
Change From Baseline in DAS28-ESR Through Week 52
Week 24
|
-2.11 Units on a Scale
Standard Deviation 1.47
|
-2.79 Units on a Scale
Standard Deviation 1.39
|
-1.60 Units on a Scale
Standard Deviation 1.37
|
-2.25 Units on a Scale
Standard Deviation 1.16
|
-2.86 Units on a Scale
Standard Deviation 1.18
|
|
Change From Baseline in DAS28-ESR Through Week 52
Week 28
|
-2.14 Units on a Scale
Standard Deviation 1.43
|
-2.87 Units on a Scale
Standard Deviation 1.37
|
-1.94 Units on a Scale
Standard Deviation 1.51
|
-2.31 Units on a Scale
Standard Deviation 1.29
|
-2.97 Units on a Scale
Standard Deviation 1.14
|
|
Change From Baseline in DAS28-ESR Through Week 52
Week 32
|
-2.28 Units on a Scale
Standard Deviation 1.41
|
-2.88 Units on a Scale
Standard Deviation 1.41
|
-1.98 Units on a Scale
Standard Deviation 1.46
|
-2.26 Units on a Scale
Standard Deviation 1.44
|
-3.01 Units on a Scale
Standard Deviation 1.13
|
|
Change From Baseline in DAS28-ESR Through Week 52
Week 36
|
-2.38 Units on a Scale
Standard Deviation 1.43
|
-3.00 Units on a Scale
Standard Deviation 1.36
|
-2.18 Units on a Scale
Standard Deviation 1.39
|
-2.28 Units on a Scale
Standard Deviation 1.35
|
-3.00 Units on a Scale
Standard Deviation 1.14
|
|
Change From Baseline in DAS28-ESR Through Week 52
Week 40
|
-2.38 Units on a Scale
Standard Deviation 1.44
|
-3.02 Units on a Scale
Standard Deviation 1.38
|
-2.12 Units on a Scale
Standard Deviation 1.44
|
-2.49 Units on a Scale
Standard Deviation 1.60
|
-3.10 Units on a Scale
Standard Deviation 1.06
|
|
Change From Baseline in DAS28-ESR Through Week 52
Week 44
|
-2.40 Units on a Scale
Standard Deviation 1.39
|
-3.02 Units on a Scale
Standard Deviation 1.51
|
-2.39 Units on a Scale
Standard Deviation 1.34
|
-2.55 Units on a Scale
Standard Deviation 1.38
|
-3.05 Units on a Scale
Standard Deviation 1.04
|
|
Change From Baseline in DAS28-ESR Through Week 52
Week 48
|
-2.32 Units on a Scale
Standard Deviation 1.40
|
-3.09 Units on a Scale
Standard Deviation 1.44
|
-2.67 Units on a Scale
Standard Deviation 1.39
|
-2.79 Units on a Scale
Standard Deviation 1.28
|
-3.16 Units on a Scale
Standard Deviation 1.09
|
|
Change From Baseline in DAS28-ESR Through Week 52
Week 52
|
-2.35 Units on a Scale
Standard Deviation 1.48
|
-3.06 Units on a Scale
Standard Deviation 1.40
|
-2.45 Units on a Scale
Standard Deviation 1.30
|
-2.67 Units on a Scale
Standard Deviation 1.23
|
-3.10 Units on a Scale
Standard Deviation 1.16
|
|
Change From Baseline in DAS28-ESR Through Week 52
EOT
|
-2.06 Units on a Scale
Standard Deviation 1.70
|
-2.81 Units on a Scale
Standard Deviation 1.47
|
-2.06 Units on a Scale
Standard Deviation 1.56
|
-2.44 Units on a Scale
Standard Deviation 1.44
|
-2.86 Units on a Scale
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: Baseline and Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
The following 68 joints subjects to assessment were examined for tender joints and the location was confirmed. Higher TJC68 indicated greater disease activity. Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8).
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in TJC (68 Joints) at Week 12
|
-4.3 Tender Joints
Standard Deviation 9.2
|
-8.2 Tender Joints
Standard Deviation 8.8
|
-9.9 Tender Joints
Standard Deviation 8.0
|
-10.7 Tender Joints
Standard Deviation 7.8
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
The following 68 joints subjects to assessment were examined for tender joints and the location was confirmed. Higher TJC68 indicated greater disease activity. Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in TJC (68 Joints) Through Week 52
Week 52
|
-10.1 Tender Joints
Standard Deviation 7.6
|
-12.8 Tender Joints
Standard Deviation 9.3
|
-11.4 Tender Joints
Standard Deviation 10.1
|
-12.9 Tender Joints
Standard Deviation 7.9
|
-12.8 Tender Joints
Standard Deviation 8.9
|
|
Change From Baseline in TJC (68 Joints) Through Week 52
EOT
|
-9.1 Tender Joints
Standard Deviation 9.7
|
-11.5 Tender Joints
Standard Deviation 9.9
|
-9.6 Tender Joints
Standard Deviation 10.7
|
-11.9 Tender Joints
Standard Deviation 8.5
|
-11.9 Tender Joints
Standard Deviation 8.8
|
|
Change From Baseline in TJC (68 Joints) Through Week 52
Week 4
|
-5.9 Tender Joints
Standard Deviation 8.0
|
-5.4 Tender Joints
Standard Deviation 6.0
|
-3.9 Tender Joints
Standard Deviation 8.1
|
-4.3 Tender Joints
Standard Deviation 6.4
|
-8.3 Tender Joints
Standard Deviation 7.7
|
|
Change From Baseline in TJC (68 Joints) Through Week 52
Week 8
|
-7.8 Tender Joints
Standard Deviation 7.6
|
-8.6 Tender Joints
Standard Deviation 7.1
|
-4.4 Tender Joints
Standard Deviation 8.4
|
-3.9 Tender Joints
Standard Deviation 8.3
|
-10.3 Tender Joints
Standard Deviation 7.1
|
|
Change From Baseline in TJC (68 Joints) Through Week 52
Week 12
|
-8.6 Tender Joints
Standard Deviation 8.8
|
-10.3 Tender Joints
Standard Deviation 8.0
|
-5.0 Tender Joints
Standard Deviation 9.7
|
-5.5 Tender Joints
Standard Deviation 7.6
|
-11.0 Tender Joints
Standard Deviation 7.6
|
|
Change From Baseline in TJC (68 Joints) Through Week 52
Week 16
|
-9.2 Tender Joints
Standard Deviation 9.2
|
-10.3 Tender Joints
Standard Deviation 8.8
|
-7.7 Tender Joints
Standard Deviation 10.2
|
-9.6 Tender Joints
Standard Deviation 7.5
|
-11.5 Tender Joints
Standard Deviation 7.6
|
|
Change From Baseline in TJC (68 Joints) Through Week 52
Week 20
|
-9.8 Tender Joints
Standard Deviation 9.2
|
-11.3 Tender Joints
Standard Deviation 8.6
|
-8.1 Tender Joints
Standard Deviation 10.8
|
-10.3 Tender Joints
Standard Deviation 7.9
|
-12.0 Tender Joints
Standard Deviation 7.9
|
|
Change From Baseline in TJC (68 Joints) Through Week 52
Week 24
|
-9.4 Tender Joints
Standard Deviation 9.4
|
-11.3 Tender Joints
Standard Deviation 9.7
|
-7.6 Tender Joints
Standard Deviation 9.9
|
-11.7 Tender Joints
Standard Deviation 7.9
|
-12.2 Tender Joints
Standard Deviation 8.2
|
|
Change From Baseline in TJC (68 Joints) Through Week 52
Week 28
|
-9.7 Tender Joints
Standard Deviation 8.8
|
-12.0 Tender Joints
Standard Deviation 9.3
|
-8.4 Tender Joints
Standard Deviation 10.3
|
-11.5 Tender Joints
Standard Deviation 8.2
|
-12.6 Tender Joints
Standard Deviation 8.6
|
|
Change From Baseline in TJC (68 Joints) Through Week 52
Week 32
|
-10.4 Tender Joints
Standard Deviation 8.5
|
-12.2 Tender Joints
Standard Deviation 8.6
|
-9.2 Tender Joints
Standard Deviation 10.3
|
-11.1 Tender Joints
Standard Deviation 8.5
|
-12.4 Tender Joints
Standard Deviation 8.9
|
|
Change From Baseline in TJC (68 Joints) Through Week 52
Week 36
|
-10.2 Tender Joints
Standard Deviation 8.6
|
-11.7 Tender Joints
Standard Deviation 8.4
|
-10.1 Tender Joints
Standard Deviation 9.5
|
-11.5 Tender Joints
Standard Deviation 8.1
|
-12.6 Tender Joints
Standard Deviation 8.6
|
|
Change From Baseline in TJC (68 Joints) Through Week 52
Week 40
|
-10.5 Tender Joints
Standard Deviation 8.5
|
-11.8 Tender Joints
Standard Deviation 8.8
|
-9.9 Tender Joints
Standard Deviation 9.6
|
-12.2 Tender Joints
Standard Deviation 8.4
|
-12.9 Tender Joints
Standard Deviation 8.8
|
|
Change From Baseline in TJC (68 Joints) Through Week 52
Week 44
|
-10.6 Tender Joints
Standard Deviation 8.2
|
-12.0 Tender Joints
Standard Deviation 8.7
|
-10.7 Tender Joints
Standard Deviation 10.0
|
-12.5 Tender Joints
Standard Deviation 7.8
|
-12.8 Tender Joints
Standard Deviation 9.0
|
|
Change From Baseline in TJC (68 Joints) Through Week 52
Week 48
|
-10.1 Tender Joints
Standard Deviation 7.1
|
-12.4 Tender Joints
Standard Deviation 9.5
|
-11.3 Tender Joints
Standard Deviation 9.6
|
-13.2 Tender Joints
Standard Deviation 7.7
|
-12.8 Tender Joints
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: Baseline and Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
The following 66 joints subjects to assessment were examined for swollen joints and the location was confirmed. Higher SJC66 indicated greater disease activity. Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8).
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Swollen Joint Count (SJC) (66 Joints) at Week 12
|
-3.2 Tender Joints
Standard Deviation 6.0
|
-6.0 Tender Joints
Standard Deviation 6.4
|
-8.4 Tender Joints
Standard Deviation 5.9
|
-8.3 Tender Joints
Standard Deviation 5.5
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
The following 66 joints subjects to assessment were examined for swollen joints and the location was confirmed. Higher SJC66 indicated greater disease activity. Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in SJC (66 Joints) Through Week 52
Week 8
|
-5.6 Swollen Joints
Standard Deviation 5.6
|
-7.1 Swollen Joints
Standard Deviation 5.2
|
-2.8 Swollen Joints
Standard Deviation 5.8
|
-3.4 Swollen Joints
Standard Deviation 4.7
|
-7.6 Swollen Joints
Standard Deviation 5.2
|
|
Change From Baseline in SJC (66 Joints) Through Week 52
EOT
|
-7.7 Swollen Joints
Standard Deviation 7.1
|
-10.0 Swollen Joints
Standard Deviation 6.5
|
-6.7 Swollen Joints
Standard Deviation 9.7
|
-8.6 Swollen Joints
Standard Deviation 8.0
|
-9.7 Swollen Joints
Standard Deviation 6.4
|
|
Change From Baseline in SJC (66 Joints) Through Week 52
Week 4
|
-4.5 Swollen Joints
Standard Deviation 4.9
|
-4.7 Swollen Joints
Standard Deviation 4.2
|
-2.5 Swollen Joints
Standard Deviation 6.0
|
-2.2 Swollen Joints
Standard Deviation 4.5
|
-6.3 Swollen Joints
Standard Deviation 5.8
|
|
Change From Baseline in SJC (66 Joints) Through Week 52
Week 12
|
-6.4 Swollen Joints
Standard Deviation 5.8
|
-8.7 Swollen Joints
Standard Deviation 6.0
|
-3.3 Swollen Joints
Standard Deviation 6.7
|
-3.9 Swollen Joints
Standard Deviation 5.6
|
-8.3 Swollen Joints
Standard Deviation 5.5
|
|
Change From Baseline in SJC (66 Joints) Through Week 52
Week 16
|
-7.7 Swollen Joints
Standard Deviation 6.0
|
-8.7 Swollen Joints
Standard Deviation 6.0
|
-6.4 Swollen Joints
Standard Deviation 6.3
|
-6.3 Swollen Joints
Standard Deviation 5.3
|
-8.7 Swollen Joints
Standard Deviation 5.3
|
|
Change From Baseline in SJC (66 Joints) Through Week 52
Week 20
|
-7.6 Swollen Joints
Standard Deviation 6.3
|
-9.1 Swollen Joints
Standard Deviation 6.2
|
-6.6 Swollen Joints
Standard Deviation 6.4
|
-7.8 Swollen Joints
Standard Deviation 6.9
|
-9.2 Swollen Joints
Standard Deviation 5.5
|
|
Change From Baseline in SJC (66 Joints) Through Week 52
Week 24
|
-7.9 Swollen Joints
Standard Deviation 6.0
|
-9.7 Swollen Joints
Standard Deviation 6.5
|
-6.5 Swollen Joints
Standard Deviation 6.2
|
-8.2 Swollen Joints
Standard Deviation 7.6
|
-9.1 Swollen Joints
Standard Deviation 5.3
|
|
Change From Baseline in SJC (66 Joints) Through Week 52
Week 28
|
-8.2 Swollen Joints
Standard Deviation 5.6
|
-10.4 Swollen Joints
Standard Deviation 5.7
|
-6.7 Swollen Joints
Standard Deviation 7.5
|
-8.7 Swollen Joints
Standard Deviation 7.4
|
-9.7 Swollen Joints
Standard Deviation 5.9
|
|
Change From Baseline in SJC (66 Joints) Through Week 52
Week 32
|
-8.2 Swollen Joints
Standard Deviation 6.3
|
-10.4 Swollen Joints
Standard Deviation 5.7
|
-5.9 Swollen Joints
Standard Deviation 8.3
|
-8.2 Swollen Joints
Standard Deviation 7.5
|
-9.8 Swollen Joints
Standard Deviation 6.1
|
|
Change From Baseline in SJC (66 Joints) Through Week 52
Week 36
|
-8.4 Swollen Joints
Standard Deviation 6.1
|
-10.4 Swollen Joints
Standard Deviation 6.1
|
-7.6 Swollen Joints
Standard Deviation 7.1
|
-8.5 Swollen Joints
Standard Deviation 7.7
|
-9.8 Swollen Joints
Standard Deviation 6.0
|
|
Change From Baseline in SJC (66 Joints) Through Week 52
Week 40
|
-8.4 Swollen Joints
Standard Deviation 5.7
|
-10.4 Swollen Joints
Standard Deviation 6.3
|
-7.6 Swollen Joints
Standard Deviation 7.0
|
-9.1 Swollen Joints
Standard Deviation 8.0
|
-10.0 Swollen Joints
Standard Deviation 6.2
|
|
Change From Baseline in SJC (66 Joints) Through Week 52
Week 44
|
-8.8 Swollen Joints
Standard Deviation 5.5
|
-10.5 Swollen Joints
Standard Deviation 6.2
|
-8.0 Swollen Joints
Standard Deviation 8.0
|
-9.3 Swollen Joints
Standard Deviation 8.0
|
-9.9 Swollen Joints
Standard Deviation 6.4
|
|
Change From Baseline in SJC (66 Joints) Through Week 52
Week 48
|
-8.6 Swollen Joints
Standard Deviation 5.8
|
-10.8 Swollen Joints
Standard Deviation 6.4
|
-8.0 Swollen Joints
Standard Deviation 7.2
|
-9.1 Swollen Joints
Standard Deviation 8.1
|
-9.9 Swollen Joints
Standard Deviation 6.0
|
|
Change From Baseline in SJC (66 Joints) Through Week 52
Week 52
|
-8.7 Swollen Joints
Standard Deviation 5.9
|
-11.0 Swollen Joints
Standard Deviation 6.0
|
-8.2 Swollen Joints
Standard Deviation 8.7
|
-9.4 Swollen Joints
Standard Deviation 8.0
|
-10.2 Swollen Joints
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Baseline and Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
Outcome measures
| Measure |
Placebo
n=100 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28-CRP < 2.6 at Week 12
|
5.0 Percentage of Participants
|
24.5 Percentage of Participants
|
34.7 Percentage of Participants
|
45.5 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52
Week 4
|
10.2 Percentage of Participants
|
5.0 Percentage of Participants
|
0.0 Percentage of Participants
|
2.1 Percentage of Participants
|
26.0 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52
Week 8
|
19.8 Percentage of Participants
|
23.5 Percentage of Participants
|
9.3 Percentage of Participants
|
2.1 Percentage of Participants
|
37.4 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52
Week 12
|
25.0 Percentage of Participants
|
37.0 Percentage of Participants
|
7.1 Percentage of Participants
|
4.3 Percentage of Participants
|
47.6 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52
Week 16
|
35.5 Percentage of Participants
|
39.8 Percentage of Participants
|
21.4 Percentage of Participants
|
23.4 Percentage of Participants
|
53.2 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52
Week 20
|
37.0 Percentage of Participants
|
51.1 Percentage of Participants
|
16.7 Percentage of Participants
|
32.6 Percentage of Participants
|
59.3 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52
Week 24
|
37.9 Percentage of Participants
|
51.7 Percentage of Participants
|
25.0 Percentage of Participants
|
33.3 Percentage of Participants
|
59.9 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52
Week 28
|
36.1 Percentage of Participants
|
55.1 Percentage of Participants
|
34.1 Percentage of Participants
|
41.3 Percentage of Participants
|
61.6 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52
Week 32
|
38.3 Percentage of Participants
|
55.8 Percentage of Participants
|
37.8 Percentage of Participants
|
37.8 Percentage of Participants
|
68.2 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52
Week 36
|
49.4 Percentage of Participants
|
54.7 Percentage of Participants
|
43.2 Percentage of Participants
|
39.5 Percentage of Participants
|
61.7 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52
Week 40
|
45.3 Percentage of Participants
|
53.5 Percentage of Participants
|
36.8 Percentage of Participants
|
45.2 Percentage of Participants
|
68.8 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52
Week 44
|
46.7 Percentage of Participants
|
57.6 Percentage of Participants
|
48.6 Percentage of Participants
|
41.0 Percentage of Participants
|
69.6 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52
Week 48
|
43.2 Percentage of Participants
|
61.9 Percentage of Participants
|
51.4 Percentage of Participants
|
56.4 Percentage of Participants
|
70.8 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52
Week 52
|
43.7 Percentage of Participants
|
66.7 Percentage of Participants
|
45.7 Percentage of Participants
|
55.3 Percentage of Participants
|
67.9 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52
EOT
|
39.2 Percentage of Participants
|
59.4 Percentage of Participants
|
41.9 Percentage of Participants
|
51.1 Percentage of Participants
|
61.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
Outcome measures
| Measure |
Placebo
n=100 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=103 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=199 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28-ESR < 2.6 at Week 12
|
1.0 Percentage of Participants
|
11.7 Percentage of Participants
|
17.8 Percentage of Participants
|
31.7 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52
Week 4
|
2.0 Percentage of Participants
|
4.0 Percentage of Participants
|
0.0 Percentage of Participants
|
2.1 Percentage of Participants
|
14.5 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52
Week 8
|
8.4 Percentage of Participants
|
13.3 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
27.7 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52
Week 12
|
11.5 Percentage of Participants
|
19.6 Percentage of Participants
|
2.4 Percentage of Participants
|
0.0 Percentage of Participants
|
33.2 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52
Week 16
|
18.3 Percentage of Participants
|
26.1 Percentage of Participants
|
11.9 Percentage of Participants
|
14.9 Percentage of Participants
|
35.1 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52
Week 20
|
22.0 Percentage of Participants
|
28.6 Percentage of Participants
|
14.6 Percentage of Participants
|
19.6 Percentage of Participants
|
38.1 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52
Week 24
|
23.0 Percentage of Participants
|
34.1 Percentage of Participants
|
15.4 Percentage of Participants
|
17.8 Percentage of Participants
|
41.4 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52
Week 28
|
27.7 Percentage of Participants
|
34.8 Percentage of Participants
|
26.8 Percentage of Participants
|
21.7 Percentage of Participants
|
39.8 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52
Week 32
|
22.2 Percentage of Participants
|
30.2 Percentage of Participants
|
19.4 Percentage of Participants
|
24.4 Percentage of Participants
|
43.4 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52
Week 36
|
25.3 Percentage of Participants
|
41.2 Percentage of Participants
|
25.0 Percentage of Participants
|
18.6 Percentage of Participants
|
40.0 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52
Week 40
|
28.9 Percentage of Participants
|
44.2 Percentage of Participants
|
32.4 Percentage of Participants
|
28.6 Percentage of Participants
|
43.9 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52
Week 44
|
32.0 Percentage of Participants
|
48.2 Percentage of Participants
|
35.3 Percentage of Participants
|
28.2 Percentage of Participants
|
43.3 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52
Week 48
|
24.3 Percentage of Participants
|
39.3 Percentage of Participants
|
37.1 Percentage of Participants
|
38.5 Percentage of Participants
|
47.6 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52
Week 52
|
25.4 Percentage of Participants
|
34.6 Percentage of Participants
|
29.4 Percentage of Participants
|
28.9 Percentage of Participants
|
43.2 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52
EOT
|
23.3 Percentage of Participants
|
28.7 Percentage of Participants
|
26.2 Percentage of Participants
|
27.7 Percentage of Participants
|
39.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
Outcome measures
| Measure |
Placebo
n=100 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28-CRP <= 3.2 at Week 12
|
11.0 Percentage of Participants
|
40.2 Percentage of Participants
|
53.5 Percentage of Participants
|
68.0 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52
Week 12
|
41.7 Percentage of Participants
|
55.4 Percentage of Participants
|
14.3 Percentage of Participants
|
10.6 Percentage of Participants
|
70.2 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52
Week 16
|
52.7 Percentage of Participants
|
64.5 Percentage of Participants
|
33.3 Percentage of Participants
|
44.7 Percentage of Participants
|
73.4 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52
Week 20
|
55.4 Percentage of Participants
|
67.4 Percentage of Participants
|
45.2 Percentage of Participants
|
47.8 Percentage of Participants
|
75.8 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52
Week 24
|
50.6 Percentage of Participants
|
74.2 Percentage of Participants
|
35.0 Percentage of Participants
|
62.2 Percentage of Participants
|
77.5 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52
Week 28
|
55.4 Percentage of Participants
|
76.4 Percentage of Participants
|
41.5 Percentage of Participants
|
63.0 Percentage of Participants
|
81.9 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52
Week 40
|
62.7 Percentage of Participants
|
76.7 Percentage of Participants
|
57.9 Percentage of Participants
|
71.4 Percentage of Participants
|
85.0 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52
EOT
|
54.9 Percentage of Participants
|
77.2 Percentage of Participants
|
48.8 Percentage of Participants
|
76.6 Percentage of Participants
|
81.5 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52
Week 4
|
18.4 Percentage of Participants
|
21.0 Percentage of Participants
|
4.7 Percentage of Participants
|
4.3 Percentage of Participants
|
47.0 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52
Week 8
|
32.3 Percentage of Participants
|
40.8 Percentage of Participants
|
11.6 Percentage of Participants
|
12.8 Percentage of Participants
|
59.5 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52
Week 32
|
58.0 Percentage of Participants
|
70.9 Percentage of Participants
|
51.4 Percentage of Participants
|
55.6 Percentage of Participants
|
83.0 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52
Week 36
|
63.3 Percentage of Participants
|
75.6 Percentage of Participants
|
56.8 Percentage of Participants
|
67.4 Percentage of Participants
|
83.4 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52
Week 44
|
61.3 Percentage of Participants
|
75.3 Percentage of Participants
|
57.1 Percentage of Participants
|
74.4 Percentage of Participants
|
83.0 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52
Week 48
|
64.9 Percentage of Participants
|
81.0 Percentage of Participants
|
60.0 Percentage of Participants
|
79.5 Percentage of Participants
|
86.3 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52
Week 52
|
63.4 Percentage of Participants
|
84.0 Percentage of Participants
|
54.3 Percentage of Participants
|
81.6 Percentage of Participants
|
89.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
Outcome measures
| Measure |
Placebo
n=100 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=103 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=199 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28-ESR <= 3.2 at Week 12
|
7.0 Percentage of Participants
|
19.4 Percentage of Participants
|
37.6 Percentage of Participants
|
49.7 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52
Week 8
|
20.0 Percentage of Participants
|
24.5 Percentage of Participants
|
9.3 Percentage of Participants
|
2.2 Percentage of Participants
|
42.6 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52
Week 36
|
48.1 Percentage of Participants
|
61.2 Percentage of Participants
|
41.7 Percentage of Participants
|
37.2 Percentage of Participants
|
62.3 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52
Week 4
|
9.2 Percentage of Participants
|
10.0 Percentage of Participants
|
0.0 Percentage of Participants
|
4.3 Percentage of Participants
|
33.0 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52
Week 12
|
19.8 Percentage of Participants
|
39.1 Percentage of Participants
|
7.1 Percentage of Participants
|
8.5 Percentage of Participants
|
51.1 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52
Week 16
|
32.3 Percentage of Participants
|
42.4 Percentage of Participants
|
21.4 Percentage of Participants
|
25.5 Percentage of Participants
|
53.7 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52
Week 20
|
36.3 Percentage of Participants
|
51.6 Percentage of Participants
|
19.5 Percentage of Participants
|
34.8 Percentage of Participants
|
56.9 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52
Week 24
|
37.9 Percentage of Participants
|
50.0 Percentage of Participants
|
23.1 Percentage of Participants
|
37.8 Percentage of Participants
|
58.6 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52
Week 28
|
36.1 Percentage of Participants
|
59.6 Percentage of Participants
|
36.6 Percentage of Participants
|
41.3 Percentage of Participants
|
60.8 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52
Week 32
|
42.0 Percentage of Participants
|
54.7 Percentage of Participants
|
38.9 Percentage of Participants
|
40.0 Percentage of Participants
|
65.7 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52
Week 40
|
51.3 Percentage of Participants
|
59.3 Percentage of Participants
|
43.2 Percentage of Participants
|
47.6 Percentage of Participants
|
67.1 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52
Week 44
|
48.0 Percentage of Participants
|
60.0 Percentage of Participants
|
50.0 Percentage of Participants
|
46.2 Percentage of Participants
|
64.3 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52
Week 48
|
45.9 Percentage of Participants
|
61.9 Percentage of Participants
|
54.3 Percentage of Participants
|
53.8 Percentage of Participants
|
72.6 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52
Week 52
|
45.1 Percentage of Participants
|
69.1 Percentage of Participants
|
41.2 Percentage of Participants
|
52.6 Percentage of Participants
|
62.3 Percentage of Participants
|
|
Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52
EOT
|
38.8 Percentage of Participants
|
61.4 Percentage of Participants
|
38.1 Percentage of Participants
|
46.8 Percentage of Participants
|
58.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
Higher CRP indicates greater disease activity.
Outcome measures
| Measure |
Placebo
n=100 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=101 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in CRP at Week 12
|
0.022 mg/dL
Standard Deviation 1.498
|
-1.056 mg/dL
Standard Deviation 1.908
|
-1.734 mg/dL
Standard Deviation 1.906
|
-1.207 mg/dL
Standard Deviation 2.694
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
Higher CRP indicates greater disease activity.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in CRP Through Week 52
Week 4
|
-0.817 mg/dL
Standard Deviation 1.566
|
-1.359 mg/dL
Standard Deviation 1.575
|
0.013 mg/dL
Standard Deviation 1.070
|
0.073 mg/dL
Standard Deviation 1.643
|
-1.360 mg/dL
Standard Deviation 1.511
|
|
Change From Baseline in CRP Through Week 52
Week 8
|
-0.967 mg/dL
Standard Deviation 1.877
|
-1.664 mg/dL
Standard Deviation 1.768
|
0.198 mg/dL
Standard Deviation 1.662
|
-0.076 mg/dL
Standard Deviation 0.930
|
-1.337 mg/dL
Standard Deviation 1.822
|
|
Change From Baseline in CRP Through Week 52
Week 12
|
-1.045 mg/dL
Standard Deviation 1.827
|
-1.810 mg/dL
Standard Deviation 1.908
|
0.026 mg/dL
Standard Deviation 1.852
|
-0.142 mg/dL
Standard Deviation 1.076
|
-1.205 mg/dL
Standard Deviation 2.735
|
|
Change From Baseline in CRP Through Week 52
Week 16
|
-1.083 mg/dL
Standard Deviation 2.062
|
-1.849 mg/dL
Standard Deviation 2.099
|
-0.802 mg/dL
Standard Deviation 2.127
|
-1.180 mg/dL
Standard Deviation 1.109
|
-1.383 mg/dL
Standard Deviation 1.639
|
|
Change From Baseline in CRP Through Week 52
Week 20
|
-0.964 mg/dL
Standard Deviation 2.551
|
-1.819 mg/dL
Standard Deviation 2.156
|
-0.581 mg/dL
Standard Deviation 2.471
|
-1.294 mg/dL
Standard Deviation 1.152
|
-1.525 mg/dL
Standard Deviation 1.643
|
|
Change From Baseline in CRP Through Week 52
Week 24
|
-1.225 mg/dL
Standard Deviation 2.168
|
-1.824 mg/dL
Standard Deviation 2.200
|
-0.434 mg/dL
Standard Deviation 2.251
|
-1.318 mg/dL
Standard Deviation 1.486
|
-1.473 mg/dL
Standard Deviation 1.847
|
|
Change From Baseline in CRP Through Week 52
Week 28
|
-1.323 mg/dL
Standard Deviation 1.976
|
-1.904 mg/dL
Standard Deviation 2.197
|
-1.013 mg/dL
Standard Deviation 2.247
|
-1.266 mg/dL
Standard Deviation 1.635
|
-1.611 mg/dL
Standard Deviation 2.000
|
|
Change From Baseline in CRP Through Week 52
Week 32
|
-1.200 mg/dL
Standard Deviation 1.973
|
-1.979 mg/dL
Standard Deviation 2.223
|
-1.239 mg/dL
Standard Deviation 2.227
|
-0.975 mg/dL
Standard Deviation 3.345
|
-1.593 mg/dL
Standard Deviation 1.886
|
|
Change From Baseline in CRP Through Week 52
Week 36
|
-1.310 mg/dL
Standard Deviation 1.874
|
-2.043 mg/dL
Standard Deviation 2.202
|
-1.084 mg/dL
Standard Deviation 2.460
|
-1.192 mg/dL
Standard Deviation 1.453
|
-1.467 mg/dL
Standard Deviation 2.233
|
|
Change From Baseline in CRP Through Week 52
Week 40
|
-1.199 mg/dL
Standard Deviation 2.011
|
-2.019 mg/dL
Standard Deviation 2.240
|
-1.325 mg/dL
Standard Deviation 2.566
|
-1.232 mg/dL
Standard Deviation 1.609
|
-1.594 mg/dL
Standard Deviation 2.146
|
|
Change From Baseline in CRP Through Week 52
Week 44
|
-1.202 mg/dL
Standard Deviation 1.961
|
-1.978 mg/dL
Standard Deviation 2.221
|
-1.292 mg/dL
Standard Deviation 2.366
|
-1.225 mg/dL
Standard Deviation 1.729
|
-1.627 mg/dL
Standard Deviation 1.810
|
|
Change From Baseline in CRP Through Week 52
Week 48
|
-0.964 mg/dL
Standard Deviation 2.074
|
-1.833 mg/dL
Standard Deviation 2.882
|
-1.610 mg/dL
Standard Deviation 2.103
|
-1.407 mg/dL
Standard Deviation 1.747
|
-1.611 mg/dL
Standard Deviation 1.858
|
|
Change From Baseline in CRP Through Week 52
Week 52
|
-1.138 mg/dL
Standard Deviation 2.056
|
-2.068 mg/dL
Standard Deviation 2.228
|
-1.566 mg/dL
Standard Deviation 2.034
|
-1.534 mg/dL
Standard Deviation 1.589
|
-1.595 mg/dL
Standard Deviation 1.873
|
|
Change From Baseline in CRP Through Week 52
EOT
|
-0.949 mg/dL
Standard Deviation 2.368
|
-1.832 mg/dL
Standard Deviation 2.221
|
-0.797 mg/dL
Standard Deviation 2.879
|
-0.987 mg/dL
Standard Deviation 3.366
|
-1.326 mg/dL
Standard Deviation 2.724
|
SECONDARY outcome
Timeframe: Baseline and Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
Higher ESR indicates greater disease activity.
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=199 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in ESR at Week 12
|
-1.96 mm/hour
Standard Deviation 17.82
|
-12.96 mm/hour
Standard Deviation 21.51
|
-23.92 mm/hour
Standard Deviation 21.26
|
-20.92 mm/hour
Standard Deviation 21.66
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
Higher ESR indicates greater disease activity.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in ESR Through Week 52
Week 40
|
-17.74 mm/hour
Standard Deviation 25.65
|
-29.79 mm/hour
Standard Deviation 24.00
|
-19.45 mm/hour
Standard Deviation 23.06
|
-21.71 mm/hour
Standard Deviation 25.48
|
-25.87 mm/hour
Standard Deviation 24.84
|
|
Change From Baseline in ESR Through Week 52
Week 4
|
-9.98 mm/hour
Standard Deviation 15.44
|
-14.99 mm/hour
Standard Deviation 15.90
|
-0.63 mm/hour
Standard Deviation 11.77
|
-3.87 mm/hour
Standard Deviation 12.99
|
-19.20 mm/hour
Standard Deviation 17.51
|
|
Change From Baseline in ESR Through Week 52
Week 8
|
-15.27 mm/hour
Standard Deviation 19.29
|
-21.59 mm/hour
Standard Deviation 19.81
|
-0.95 mm/hour
Standard Deviation 12.47
|
-2.07 mm/hour
Standard Deviation 14.31
|
-20.88 mm/hour
Standard Deviation 19.43
|
|
Change From Baseline in ESR Through Week 52
Week 12
|
-13.49 mm/hour
Standard Deviation 21.25
|
-25.26 mm/hour
Standard Deviation 21.22
|
-2.62 mm/hour
Standard Deviation 18.31
|
-4.43 mm/hour
Standard Deviation 17.07
|
-21.74 mm/hour
Standard Deviation 20.67
|
|
Change From Baseline in ESR Through Week 52
Week 16
|
-15.34 mm/hour
Standard Deviation 20.98
|
-28.32 mm/hour
Standard Deviation 21.66
|
-11.76 mm/hour
Standard Deviation 19.87
|
-16.89 mm/hour
Standard Deviation 17.70
|
-22.05 mm/hour
Standard Deviation 19.53
|
|
Change From Baseline in ESR Through Week 52
Week 20
|
-16.77 mm/hour
Standard Deviation 21.88
|
-27.34 mm/hour
Standard Deviation 21.95
|
-12.69 mm/hour
Standard Deviation 23.03
|
-20.62 mm/hour
Standard Deviation 17.65
|
-21.91 mm/hour
Standard Deviation 20.59
|
|
Change From Baseline in ESR Through Week 52
Week 24
|
-17.61 mm/hour
Standard Deviation 22.60
|
-27.02 mm/hour
Standard Deviation 26.00
|
-13.18 mm/hour
Standard Deviation 21.90
|
-20.04 mm/hour
Standard Deviation 18.45
|
-22.20 mm/hour
Standard Deviation 23.87
|
|
Change From Baseline in ESR Through Week 52
Week 28
|
-16.47 mm/hour
Standard Deviation 21.90
|
-27.21 mm/hour
Standard Deviation 23.97
|
-16.29 mm/hour
Standard Deviation 17.77
|
-18.02 mm/hour
Standard Deviation 24.26
|
-23.52 mm/hour
Standard Deviation 22.35
|
|
Change From Baseline in ESR Through Week 52
Week 32
|
-16.35 mm/hour
Standard Deviation 23.09
|
-27.02 mm/hour
Standard Deviation 23.81
|
-19.54 mm/hour
Standard Deviation 21.98
|
-19.93 mm/hour
Standard Deviation 25.80
|
-24.75 mm/hour
Standard Deviation 21.27
|
|
Change From Baseline in ESR Through Week 52
Week 36
|
-18.67 mm/hour
Standard Deviation 23.77
|
-29.50 mm/hour
Standard Deviation 25.26
|
-19.65 mm/hour
Standard Deviation 22.64
|
-21.99 mm/hour
Standard Deviation 21.52
|
-24.66 mm/hour
Standard Deviation 22.32
|
|
Change From Baseline in ESR Through Week 52
Week 44
|
-17.77 mm/hour
Standard Deviation 25.35
|
-29.07 mm/hour
Standard Deviation 24.47
|
-21.43 mm/hour
Standard Deviation 24.12
|
-22.31 mm/hour
Standard Deviation 23.12
|
-25.73 mm/hour
Standard Deviation 21.09
|
|
Change From Baseline in ESR Through Week 52
Week 48
|
-15.43 mm/hour
Standard Deviation 25.70
|
-28.70 mm/hour
Standard Deviation 24.69
|
-23.40 mm/hour
Standard Deviation 23.87
|
-25.66 mm/hour
Standard Deviation 22.30
|
-25.98 mm/hour
Standard Deviation 22.00
|
|
Change From Baseline in ESR Through Week 52
Week 52
|
-16.77 mm/hour
Standard Deviation 26.05
|
-28.59 mm/hour
Standard Deviation 24.97
|
-21.03 mm/hour
Standard Deviation 19.81
|
-23.24 mm/hour
Standard Deviation 24.28
|
-24.23 mm/hour
Standard Deviation 21.70
|
|
Change From Baseline in ESR Through Week 52
EOT
|
-14.94 mm/hour
Standard Deviation 27.20
|
-26.15 mm/hour
Standard Deviation 25.02
|
-15.37 mm/hour
Standard Deviation 24.27
|
-18.61 mm/hour
Standard Deviation 27.67
|
-20.75 mm/hour
Standard Deviation 26.25
|
SECONDARY outcome
Timeframe: Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline \> 1.2.
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=101 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With a European League Against Rheumatism (EULAR) Good Response Using DAS28-CRP at Week 12
|
9.1 Percentage of Participants
|
38.6 Percentage of Participants
|
51.5 Percentage of Participants
|
65.5 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline \> 1.2.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52
EOT
|
52.5 Percentage of Participants
|
75.2 Percentage of Participants
|
47.6 Percentage of Participants
|
72.3 Percentage of Participants
|
80.0 Percentage of Participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52
Week 4
|
17.3 Percentage of Participants
|
16.0 Percentage of Participants
|
4.8 Percentage of Participants
|
2.1 Percentage of Participants
|
44.5 Percentage of Participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52
Week 8
|
28.1 Percentage of Participants
|
39.8 Percentage of Participants
|
11.9 Percentage of Participants
|
6.4 Percentage of Participants
|
56.4 Percentage of Participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52
Week 12
|
39.6 Percentage of Participants
|
53.3 Percentage of Participants
|
12.2 Percentage of Participants
|
8.5 Percentage of Participants
|
67.5 Percentage of Participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52
Week 16
|
48.4 Percentage of Participants
|
60.2 Percentage of Participants
|
34.1 Percentage of Participants
|
40.4 Percentage of Participants
|
72.9 Percentage of Participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52
Week 20
|
51.1 Percentage of Participants
|
65.2 Percentage of Participants
|
46.3 Percentage of Participants
|
43.5 Percentage of Participants
|
75.8 Percentage of Participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52
Week 24
|
47.1 Percentage of Participants
|
71.9 Percentage of Participants
|
33.3 Percentage of Participants
|
57.8 Percentage of Participants
|
76.4 Percentage of Participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52
Week 28
|
50.6 Percentage of Participants
|
74.2 Percentage of Participants
|
40.0 Percentage of Participants
|
58.7 Percentage of Participants
|
80.8 Percentage of Participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52
Week 32
|
54.3 Percentage of Participants
|
68.6 Percentage of Participants
|
50.0 Percentage of Participants
|
46.7 Percentage of Participants
|
83.0 Percentage of Participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52
Week 36
|
59.5 Percentage of Participants
|
74.4 Percentage of Participants
|
55.6 Percentage of Participants
|
62.8 Percentage of Participants
|
83.4 Percentage of Participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52
Week 40
|
58.7 Percentage of Participants
|
75.6 Percentage of Participants
|
54.1 Percentage of Participants
|
66.7 Percentage of Participants
|
84.4 Percentage of Participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52
Week 44
|
58.7 Percentage of Participants
|
74.1 Percentage of Participants
|
55.9 Percentage of Participants
|
71.8 Percentage of Participants
|
82.5 Percentage of Participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52
Week 48
|
60.8 Percentage of Participants
|
79.8 Percentage of Participants
|
55.9 Percentage of Participants
|
79.5 Percentage of Participants
|
85.1 Percentage of Participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52
Week 52
|
59.2 Percentage of Participants
|
81.5 Percentage of Participants
|
52.9 Percentage of Participants
|
78.9 Percentage of Participants
|
88.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline \> 0.6, or DAS28 after treatment \> 5.1 and improvement from baseline \> 1.2.
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=101 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12
|
41.4 Percentage of Participants
|
75.2 Percentage of Participants
|
92.1 Percentage of Participants
|
92.5 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline \> 0.6, or DAS28 after treatment \> 5.1 and improvement from baseline \> 1.2.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52
Week 28
|
89.2 Percentage of Participants
|
95.5 Percentage of Participants
|
80.0 Percentage of Participants
|
87.0 Percentage of Participants
|
99.4 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52
Week 32
|
91.4 Percentage of Participants
|
96.5 Percentage of Participants
|
83.3 Percentage of Participants
|
82.2 Percentage of Participants
|
98.3 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52
Week 36
|
87.3 Percentage of Participants
|
96.5 Percentage of Participants
|
86.1 Percentage of Participants
|
86.0 Percentage of Participants
|
97.7 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52
Week 40
|
89.3 Percentage of Participants
|
96.5 Percentage of Participants
|
86.5 Percentage of Participants
|
85.7 Percentage of Participants
|
100.0 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52
Week 44
|
93.3 Percentage of Participants
|
94.1 Percentage of Participants
|
88.2 Percentage of Participants
|
87.2 Percentage of Participants
|
99.4 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52
Week 4
|
63.3 Percentage of Participants
|
72.0 Percentage of Participants
|
31.0 Percentage of Participants
|
40.4 Percentage of Participants
|
87.5 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52
Week 8
|
76.0 Percentage of Participants
|
86.7 Percentage of Participants
|
47.6 Percentage of Participants
|
40.4 Percentage of Participants
|
92.3 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52
Week 12
|
77.1 Percentage of Participants
|
94.6 Percentage of Participants
|
41.5 Percentage of Participants
|
48.9 Percentage of Participants
|
94.2 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52
Week 16
|
81.7 Percentage of Participants
|
92.5 Percentage of Participants
|
73.2 Percentage of Participants
|
85.1 Percentage of Participants
|
96.8 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52
Week 20
|
79.3 Percentage of Participants
|
96.7 Percentage of Participants
|
78.0 Percentage of Participants
|
91.3 Percentage of Participants
|
95.6 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52
Week 24
|
85.1 Percentage of Participants
|
96.6 Percentage of Participants
|
71.8 Percentage of Participants
|
91.1 Percentage of Participants
|
97.3 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52
Week 48
|
90.5 Percentage of Participants
|
97.6 Percentage of Participants
|
94.1 Percentage of Participants
|
89.7 Percentage of Participants
|
98.2 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52
Week 52
|
91.5 Percentage of Participants
|
98.8 Percentage of Participants
|
94.1 Percentage of Participants
|
92.1 Percentage of Participants
|
98.8 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52
EOT
|
78.2 Percentage of Participants
|
93.1 Percentage of Participants
|
83.3 Percentage of Participants
|
85.1 Percentage of Participants
|
95.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline \> 1.2.
Outcome measures
| Measure |
Placebo
n=98 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=198 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With a Good EULAR Response Using DAS28-ESR at Week 12
|
5.1 Percentage of Participants
|
18.6 Percentage of Participants
|
36.6 Percentage of Participants
|
49.0 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline \> 1.2.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52
EOT
|
38.2 Percentage of Participants
|
61.4 Percentage of Participants
|
36.6 Percentage of Participants
|
43.5 Percentage of Participants
|
57.3 Percentage of Participants
|
|
Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52
Week 4
|
8.2 Percentage of Participants
|
10.0 Percentage of Participants
|
0.0 Percentage of Participants
|
2.2 Percentage of Participants
|
31.7 Percentage of Participants
|
|
Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52
Week 8
|
16.8 Percentage of Participants
|
24.5 Percentage of Participants
|
9.5 Percentage of Participants
|
0.0 Percentage of Participants
|
41.2 Percentage of Participants
|
|
Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52
Week 12
|
18.8 Percentage of Participants
|
38.0 Percentage of Participants
|
4.9 Percentage of Participants
|
6.5 Percentage of Participants
|
50.0 Percentage of Participants
|
|
Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52
Week 16
|
31.2 Percentage of Participants
|
40.2 Percentage of Participants
|
22.0 Percentage of Participants
|
21.7 Percentage of Participants
|
52.7 Percentage of Participants
|
|
Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52
Week 20
|
34.1 Percentage of Participants
|
51.6 Percentage of Participants
|
20.0 Percentage of Participants
|
31.1 Percentage of Participants
|
56.4 Percentage of Participants
|
|
Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52
Week 24
|
35.6 Percentage of Participants
|
50.0 Percentage of Participants
|
21.1 Percentage of Participants
|
34.1 Percentage of Participants
|
56.4 Percentage of Participants
|
|
Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52
Week 28
|
32.5 Percentage of Participants
|
59.6 Percentage of Participants
|
35.0 Percentage of Participants
|
37.8 Percentage of Participants
|
59.7 Percentage of Participants
|
|
Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52
Week 32
|
39.5 Percentage of Participants
|
54.7 Percentage of Participants
|
37.1 Percentage of Participants
|
36.4 Percentage of Participants
|
63.4 Percentage of Participants
|
|
Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52
Week 36
|
44.3 Percentage of Participants
|
60.0 Percentage of Participants
|
40.0 Percentage of Participants
|
33.3 Percentage of Participants
|
62.3 Percentage of Participants
|
|
Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52
Week 40
|
47.4 Percentage of Participants
|
59.3 Percentage of Participants
|
41.7 Percentage of Participants
|
43.9 Percentage of Participants
|
67.1 Percentage of Participants
|
|
Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52
Week 44
|
45.3 Percentage of Participants
|
60.0 Percentage of Participants
|
48.5 Percentage of Participants
|
43.6 Percentage of Participants
|
63.7 Percentage of Participants
|
|
Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52
Week 48
|
41.9 Percentage of Participants
|
61.9 Percentage of Participants
|
52.9 Percentage of Participants
|
52.6 Percentage of Participants
|
72.6 Percentage of Participants
|
|
Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52
Week 52
|
43.7 Percentage of Participants
|
69.1 Percentage of Participants
|
39.4 Percentage of Participants
|
48.6 Percentage of Participants
|
61.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline \> 0.6, or DAS28 after treatment \> 5.1 and improvement from baseline \> 1.2.
Outcome measures
| Measure |
Placebo
n=98 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=198 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR at Week 12
|
37.8 Percentage of Participants
|
69.6 Percentage of Participants
|
88.1 Percentage of Participants
|
90.9 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline \> 0.6, or DAS28 after treatment \> 5.1 and improvement from baseline \> 1.2.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52
Week 28
|
84.3 Percentage of Participants
|
92.1 Percentage of Participants
|
77.5 Percentage of Participants
|
88.9 Percentage of Participants
|
97.7 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52
Week 32
|
90.1 Percentage of Participants
|
94.2 Percentage of Participants
|
77.1 Percentage of Participants
|
86.4 Percentage of Participants
|
97.1 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52
Week 4
|
56.1 Percentage of Participants
|
65.0 Percentage of Participants
|
31.0 Percentage of Participants
|
23.9 Percentage of Participants
|
81.9 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52
Week 8
|
66.3 Percentage of Participants
|
84.7 Percentage of Participants
|
45.2 Percentage of Participants
|
33.3 Percentage of Participants
|
92.8 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52
Week 12
|
70.8 Percentage of Participants
|
90.2 Percentage of Participants
|
39.0 Percentage of Participants
|
43.5 Percentage of Participants
|
92.6 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52
Week 16
|
76.3 Percentage of Participants
|
88.0 Percentage of Participants
|
73.2 Percentage of Participants
|
76.1 Percentage of Participants
|
94.7 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52
Week 20
|
79.1 Percentage of Participants
|
96.7 Percentage of Participants
|
72.5 Percentage of Participants
|
86.7 Percentage of Participants
|
93.9 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52
Week 24
|
82.8 Percentage of Participants
|
95.5 Percentage of Participants
|
73.7 Percentage of Participants
|
90.9 Percentage of Participants
|
96.1 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52
Week 36
|
83.5 Percentage of Participants
|
95.3 Percentage of Participants
|
85.7 Percentage of Participants
|
83.3 Percentage of Participants
|
96.6 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52
Week 40
|
89.5 Percentage of Participants
|
95.3 Percentage of Participants
|
83.3 Percentage of Participants
|
85.4 Percentage of Participants
|
98.3 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52
Week 44
|
90.7 Percentage of Participants
|
92.9 Percentage of Participants
|
84.8 Percentage of Participants
|
87.2 Percentage of Participants
|
98.2 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52
Week 48
|
86.5 Percentage of Participants
|
95.2 Percentage of Participants
|
88.2 Percentage of Participants
|
89.5 Percentage of Participants
|
98.2 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52
Week 52
|
84.5 Percentage of Participants
|
97.5 Percentage of Participants
|
84.8 Percentage of Participants
|
89.2 Percentage of Participants
|
98.1 Percentage of Participants
|
|
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52
EOT
|
74.5 Percentage of Participants
|
94.1 Percentage of Participants
|
75.6 Percentage of Participants
|
82.6 Percentage of Participants
|
93.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤ 1, CRP ≤ 1 mg/dL, and subject's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm). Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups.
Outcome measures
| Measure |
Placebo
n=100 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving ACR / EULAR Remission at Week 12
|
2.0 Percentage of Participants
|
5.9 Percentage of Participants
|
5.9 Percentage of Participants
|
13.5 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤ 1, CRP ≤ 1 mg/dL, and subject's global assessment of arthritis ≤ 1 cm (on a VAS of 0 - 100 mm).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52
Week 4
|
1.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
7.0 Percentage of Participants
|
|
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52
Week 12
|
6.3 Percentage of Participants
|
6.5 Percentage of Participants
|
0.0 Percentage of Participants
|
4.3 Percentage of Participants
|
14.1 Percentage of Participants
|
|
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52
Week 16
|
11.8 Percentage of Participants
|
8.6 Percentage of Participants
|
4.8 Percentage of Participants
|
2.1 Percentage of Participants
|
18.6 Percentage of Participants
|
|
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52
Week 20
|
12.0 Percentage of Participants
|
13.0 Percentage of Participants
|
4.8 Percentage of Participants
|
6.5 Percentage of Participants
|
20.9 Percentage of Participants
|
|
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52
Week 36
|
16.5 Percentage of Participants
|
18.6 Percentage of Participants
|
8.1 Percentage of Participants
|
7.0 Percentage of Participants
|
22.3 Percentage of Participants
|
|
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52
Week 8
|
2.1 Percentage of Participants
|
1.0 Percentage of Participants
|
2.3 Percentage of Participants
|
0.0 Percentage of Participants
|
11.8 Percentage of Participants
|
|
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52
Week 24
|
13.8 Percentage of Participants
|
10.1 Percentage of Participants
|
5.0 Percentage of Participants
|
8.9 Percentage of Participants
|
28.0 Percentage of Participants
|
|
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52
Week 28
|
12.0 Percentage of Participants
|
18.0 Percentage of Participants
|
9.8 Percentage of Participants
|
10.9 Percentage of Participants
|
24.3 Percentage of Participants
|
|
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52
Week 32
|
13.6 Percentage of Participants
|
20.9 Percentage of Participants
|
10.8 Percentage of Participants
|
11.1 Percentage of Participants
|
25.0 Percentage of Participants
|
|
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52
Week 40
|
16.0 Percentage of Participants
|
19.8 Percentage of Participants
|
7.9 Percentage of Participants
|
14.3 Percentage of Participants
|
24.3 Percentage of Participants
|
|
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52
Week 44
|
16.0 Percentage of Participants
|
24.7 Percentage of Participants
|
20.0 Percentage of Participants
|
7.7 Percentage of Participants
|
25.1 Percentage of Participants
|
|
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52
Week 48
|
17.6 Percentage of Participants
|
25.0 Percentage of Participants
|
25.7 Percentage of Participants
|
15.4 Percentage of Participants
|
27.4 Percentage of Participants
|
|
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52
Week 52
|
18.3 Percentage of Participants
|
18.5 Percentage of Participants
|
22.9 Percentage of Participants
|
10.5 Percentage of Participants
|
30.2 Percentage of Participants
|
|
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52
EOT
|
14.7 Percentage of Participants
|
15.8 Percentage of Participants
|
20.9 Percentage of Participants
|
8.5 Percentage of Participants
|
25.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description. SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3. Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups.
Outcome measures
| Measure |
Placebo
n=100 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission at Week 12
|
0.0 Percentage of Participants
|
8.8 Percentage of Participants
|
8.9 Percentage of Participants
|
18.5 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description. SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving SDAI Remission Through Week 52
Week 8
|
4.2 Percentage of Participants
|
6.1 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
16.9 Percentage of Participants
|
|
Percentage of Participants Achieving SDAI Remission Through Week 52
Week 16
|
12.9 Percentage of Participants
|
15.1 Percentage of Participants
|
2.4 Percentage of Participants
|
8.5 Percentage of Participants
|
23.9 Percentage of Participants
|
|
Percentage of Participants Achieving SDAI Remission Through Week 52
Week 28
|
19.3 Percentage of Participants
|
29.2 Percentage of Participants
|
17.1 Percentage of Participants
|
17.4 Percentage of Participants
|
33.9 Percentage of Participants
|
|
Percentage of Participants Achieving SDAI Remission Through Week 52
Week 36
|
21.5 Percentage of Participants
|
27.9 Percentage of Participants
|
18.9 Percentage of Participants
|
4.7 Percentage of Participants
|
30.9 Percentage of Participants
|
|
Percentage of Participants Achieving SDAI Remission Through Week 52
Week 44
|
22.7 Percentage of Participants
|
38.8 Percentage of Participants
|
20.0 Percentage of Participants
|
15.4 Percentage of Participants
|
34.5 Percentage of Participants
|
|
Percentage of Participants Achieving SDAI Remission Through Week 52
Week 48
|
18.9 Percentage of Participants
|
38.1 Percentage of Participants
|
28.6 Percentage of Participants
|
25.6 Percentage of Participants
|
39.3 Percentage of Participants
|
|
Percentage of Participants Achieving SDAI Remission Through Week 52
EOT
|
17.6 Percentage of Participants
|
25.7 Percentage of Participants
|
18.6 Percentage of Participants
|
17.0 Percentage of Participants
|
33.5 Percentage of Participants
|
|
Percentage of Participants Achieving SDAI Remission Through Week 52
Week 4
|
1.0 Percentage of Participants
|
1.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
10.0 Percentage of Participants
|
|
Percentage of Participants Achieving SDAI Remission Through Week 52
Week 12
|
9.4 Percentage of Participants
|
9.8 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
19.4 Percentage of Participants
|
|
Percentage of Participants Achieving SDAI Remission Through Week 52
Week 20
|
17.4 Percentage of Participants
|
18.5 Percentage of Participants
|
4.8 Percentage of Participants
|
15.2 Percentage of Participants
|
29.7 Percentage of Participants
|
|
Percentage of Participants Achieving SDAI Remission Through Week 52
Week 24
|
18.4 Percentage of Participants
|
18.0 Percentage of Participants
|
10.0 Percentage of Participants
|
17.8 Percentage of Participants
|
34.1 Percentage of Participants
|
|
Percentage of Participants Achieving SDAI Remission Through Week 52
Week 32
|
16.0 Percentage of Participants
|
27.9 Percentage of Participants
|
13.5 Percentage of Participants
|
13.3 Percentage of Participants
|
35.2 Percentage of Participants
|
|
Percentage of Participants Achieving SDAI Remission Through Week 52
Week 40
|
24.0 Percentage of Participants
|
36.0 Percentage of Participants
|
10.5 Percentage of Participants
|
19.0 Percentage of Participants
|
33.5 Percentage of Participants
|
|
Percentage of Participants Achieving SDAI Remission Through Week 52
Week 52
|
21.1 Percentage of Participants
|
29.6 Percentage of Participants
|
20.0 Percentage of Participants
|
21.1 Percentage of Participants
|
39.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description. SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity.
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=101 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in SDAI Score at Week 12
|
-7.22 Units on a Scale
Standard Deviation 14.11
|
-16.08 Units on a Scale
Standard Deviation 14.37
|
-20.93 Units on a Scale
Standard Deviation 11.32
|
-21.94 Units on a Scale
Standard Deviation 11.21
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description. SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in SDAI Score Through Week 52
Week 24
|
-20.14 Units on a Scale
Standard Deviation 13.96
|
-24.40 Units on a Scale
Standard Deviation 12.00
|
-16.13 Units on a Scale
Standard Deviation 14.40
|
-22.25 Units on a Scale
Standard Deviation 13.22
|
-24.78 Units on a Scale
Standard Deviation 10.14
|
|
Change From Baseline in SDAI Score Through Week 52
Week 28
|
-20.29 Units on a Scale
Standard Deviation 12.71
|
-25.29 Units on a Scale
Standard Deviation 12.32
|
-17.75 Units on a Scale
Standard Deviation 15.21
|
-22.74 Units on a Scale
Standard Deviation 13.00
|
-25.70 Units on a Scale
Standard Deviation 10.51
|
|
Change From Baseline in SDAI Score Through Week 52
Week 4
|
-11.83 Units on a Scale
Standard Deviation 9.97
|
-12.78 Units on a Scale
Standard Deviation 9.06
|
-5.57 Units on a Scale
Standard Deviation 9.50
|
-7.21 Units on a Scale
Standard Deviation 9.35
|
-17.09 Units on a Scale
Standard Deviation 10.83
|
|
Change From Baseline in SDAI Score Through Week 52
Week 8
|
-14.71 Units on a Scale
Standard Deviation 12.53
|
-18.66 Units on a Scale
Standard Deviation 9.73
|
-7.07 Units on a Scale
Standard Deviation 12.26
|
-8.43 Units on a Scale
Standard Deviation 11.37
|
-20.64 Units on a Scale
Standard Deviation 10.09
|
|
Change From Baseline in SDAI Score Through Week 52
Week 12
|
-16.59 Units on a Scale
Standard Deviation 13.47
|
-21.62 Units on a Scale
Standard Deviation 11.48
|
-7.48 Units on a Scale
Standard Deviation 14.80
|
-10.18 Units on a Scale
Standard Deviation 11.82
|
-22.54 Units on a Scale
Standard Deviation 10.79
|
|
Change From Baseline in SDAI Score Through Week 52
Week 16
|
-19.25 Units on a Scale
Standard Deviation 13.76
|
-21.90 Units on a Scale
Standard Deviation 12.19
|
-15.20 Units on a Scale
Standard Deviation 14.25
|
-18.90 Units on a Scale
Standard Deviation 12.08
|
-23.46 Units on a Scale
Standard Deviation 10.37
|
|
Change From Baseline in SDAI Score Through Week 52
Week 20
|
-19.47 Units on a Scale
Standard Deviation 14.16
|
-23.37 Units on a Scale
Standard Deviation 11.94
|
-15.67 Units on a Scale
Standard Deviation 15.41
|
-20.61 Units on a Scale
Standard Deviation 12.44
|
-24.44 Units on a Scale
Standard Deviation 10.15
|
|
Change From Baseline in SDAI Score Through Week 52
Week 32
|
-21.72 Units on a Scale
Standard Deviation 12.82
|
-25.28 Units on a Scale
Standard Deviation 12.07
|
-17.71 Units on a Scale
Standard Deviation 15.34
|
-21.14 Units on a Scale
Standard Deviation 14.69
|
-25.84 Units on a Scale
Standard Deviation 10.79
|
|
Change From Baseline in SDAI Score Through Week 52
Week 36
|
-21.34 Units on a Scale
Standard Deviation 12.65
|
-25.62 Units on a Scale
Standard Deviation 11.95
|
-20.57 Units on a Scale
Standard Deviation 14.03
|
-22.02 Units on a Scale
Standard Deviation 13.54
|
-25.77 Units on a Scale
Standard Deviation 11.33
|
|
Change From Baseline in SDAI Score Through Week 52
Week 40
|
-21.55 Units on a Scale
Standard Deviation 13.04
|
-25.78 Units on a Scale
Standard Deviation 12.54
|
-20.34 Units on a Scale
Standard Deviation 14.90
|
-23.09 Units on a Scale
Standard Deviation 14.63
|
-26.46 Units on a Scale
Standard Deviation 11.11
|
|
Change From Baseline in SDAI Score Through Week 52
Week 44
|
-21.54 Units on a Scale
Standard Deviation 12.22
|
-25.82 Units on a Scale
Standard Deviation 12.92
|
-22.65 Units on a Scale
Standard Deviation 13.74
|
-23.23 Units on a Scale
Standard Deviation 14.31
|
-26.17 Units on a Scale
Standard Deviation 11.06
|
|
Change From Baseline in SDAI Score Through Week 52
Week 48
|
-21.11 Units on a Scale
Standard Deviation 12.13
|
-26.33 Units on a Scale
Standard Deviation 12.58
|
-23.21 Units on a Scale
Standard Deviation 13.47
|
-24.61 Units on a Scale
Standard Deviation 13.35
|
-26.57 Units on a Scale
Standard Deviation 11.02
|
|
Change From Baseline in SDAI Score Through Week 52
Week 52
|
-21.19 Units on a Scale
Standard Deviation 12.83
|
-26.99 Units on a Scale
Standard Deviation 12.52
|
-23.04 Units on a Scale
Standard Deviation 13.57
|
-25.20 Units on a Scale
Standard Deviation 13.91
|
-26.77 Units on a Scale
Standard Deviation 11.57
|
|
Change From Baseline in SDAI Score Through Week 52
EOT
|
-18.92 Units on a Scale
Standard Deviation 15.76
|
-24.95 Units on a Scale
Standard Deviation 12.77
|
-18.76 Units on a Scale
Standard Deviation 16.83
|
-22.38 Units on a Scale
Standard Deviation 15.91
|
-24.85 Units on a Scale
Standard Deviation 12.19
|
SECONDARY outcome
Timeframe: Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description. CDAI = TJC + SJC + SGA + PGA. CDAI. Remission was defined as CDAI score ≤ 2.8. Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups.
Outcome measures
| Measure |
Placebo
n=100 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=103 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Score <= 2.8 at Week 12
|
0.0 Percentage of Participants
|
8.7 Percentage of Participants
|
9.9 Percentage of Participants
|
19.0 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description. CDAI = TJC + SJC + SGA + PGA. CDAI. Remission was defined as CDAI score ≤ 2.8.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52
Week 44
|
21.3 Percentage of Participants
|
36.5 Percentage of Participants
|
25.7 Percentage of Participants
|
15.4 Percentage of Participants
|
33.3 Percentage of Participants
|
|
Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52
Week 4
|
1.0 Percentage of Participants
|
2.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
9.0 Percentage of Participants
|
|
Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52
Week 8
|
4.2 Percentage of Participants
|
6.1 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
14.4 Percentage of Participants
|
|
Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52
Week 12
|
9.4 Percentage of Participants
|
10.9 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
19.9 Percentage of Participants
|
|
Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52
Week 16
|
14.0 Percentage of Participants
|
16.1 Percentage of Participants
|
2.4 Percentage of Participants
|
6.4 Percentage of Participants
|
23.9 Percentage of Participants
|
|
Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52
Week 20
|
18.5 Percentage of Participants
|
17.4 Percentage of Participants
|
2.4 Percentage of Participants
|
10.9 Percentage of Participants
|
28.0 Percentage of Participants
|
|
Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52
Week 24
|
16.1 Percentage of Participants
|
15.6 Percentage of Participants
|
7.5 Percentage of Participants
|
15.6 Percentage of Participants
|
31.9 Percentage of Participants
|
|
Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52
Week 28
|
20.5 Percentage of Participants
|
27.0 Percentage of Participants
|
14.6 Percentage of Participants
|
17.4 Percentage of Participants
|
31.6 Percentage of Participants
|
|
Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52
Week 32
|
17.3 Percentage of Participants
|
27.9 Percentage of Participants
|
16.2 Percentage of Participants
|
13.3 Percentage of Participants
|
32.4 Percentage of Participants
|
|
Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52
Week 36
|
19.0 Percentage of Participants
|
26.7 Percentage of Participants
|
18.9 Percentage of Participants
|
7.0 Percentage of Participants
|
30.3 Percentage of Participants
|
|
Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52
Week 40
|
22.4 Percentage of Participants
|
29.1 Percentage of Participants
|
13.2 Percentage of Participants
|
21.4 Percentage of Participants
|
31.8 Percentage of Participants
|
|
Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52
Week 48
|
23.0 Percentage of Participants
|
34.5 Percentage of Participants
|
28.6 Percentage of Participants
|
23.1 Percentage of Participants
|
36.3 Percentage of Participants
|
|
Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52
Week 52
|
21.1 Percentage of Participants
|
27.2 Percentage of Participants
|
22.9 Percentage of Participants
|
18.4 Percentage of Participants
|
38.3 Percentage of Participants
|
|
Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52
EOT
|
18.4 Percentage of Participants
|
23.8 Percentage of Participants
|
20.9 Percentage of Participants
|
17.0 Percentage of Participants
|
32.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description. CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity.
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in CDAI Score at Week 12
|
-7.25 Units on a Scale
Standard Deviation 13.42
|
-14.91 Units on a Scale
Standard Deviation 13.46
|
-19.20 Units on a Scale
Standard Deviation 11.04
|
-20.74 Units on a Scale
Standard Deviation 10.64
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description. CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in CDAI Score Through Week 52
Week 8
|
-13.74 Units on a Scale
Standard Deviation 11.77
|
-17.06 Units on a Scale
Standard Deviation 9.58
|
-7.29 Units on a Scale
Standard Deviation 11.46
|
-8.35 Units on a Scale
Standard Deviation 11.10
|
-19.31 Units on a Scale
Standard Deviation 9.69
|
|
Change From Baseline in CDAI Score Through Week 52
Week 12
|
-15.55 Units on a Scale
Standard Deviation 12.71
|
-19.81 Units on a Scale
Standard Deviation 11.21
|
-7.52 Units on a Scale
Standard Deviation 13.88
|
-10.04 Units on a Scale
Standard Deviation 11.47
|
-21.21 Units on a Scale
Standard Deviation 10.39
|
|
Change From Baseline in CDAI Score Through Week 52
Week 24
|
-18.92 Units on a Scale
Standard Deviation 12.65
|
-22.28 Units on a Scale
Standard Deviation 11.75
|
-15.71 Units on a Scale
Standard Deviation 13.08
|
-20.93 Units on a Scale
Standard Deviation 12.88
|
-23.30 Units on a Scale
Standard Deviation 9.93
|
|
Change From Baseline in CDAI Score Through Week 52
Week 28
|
-18.97 Units on a Scale
Standard Deviation 12.06
|
-23.38 Units on a Scale
Standard Deviation 11.76
|
-16.74 Units on a Scale
Standard Deviation 14.06
|
-21.48 Units on a Scale
Standard Deviation 12.70
|
-24.09 Units on a Scale
Standard Deviation 10.26
|
|
Change From Baseline in CDAI Score Through Week 52
Week 44
|
-20.34 Units on a Scale
Standard Deviation 11.43
|
-23.84 Units on a Scale
Standard Deviation 12.25
|
-21.34 Units on a Scale
Standard Deviation 12.56
|
-22.00 Units on a Scale
Standard Deviation 13.79
|
-24.54 Units on a Scale
Standard Deviation 10.81
|
|
Change From Baseline in CDAI Score Through Week 52
Week 48
|
-20.11 Units on a Scale
Standard Deviation 11.47
|
-24.50 Units on a Scale
Standard Deviation 11.77
|
-21.58 Units on a Scale
Standard Deviation 12.56
|
-23.20 Units on a Scale
Standard Deviation 13.03
|
-24.96 Units on a Scale
Standard Deviation 10.70
|
|
Change From Baseline in CDAI Score Through Week 52
Week 4
|
-11.01 Units on a Scale
Standard Deviation 9.47
|
-11.42 Units on a Scale
Standard Deviation 8.99
|
-5.61 Units on a Scale
Standard Deviation 9.16
|
-7.28 Units on a Scale
Standard Deviation 8.76
|
-15.73 Units on a Scale
Standard Deviation 10.51
|
|
Change From Baseline in CDAI Score Through Week 52
Week 16
|
-18.17 Units on a Scale
Standard Deviation 12.81
|
-20.06 Units on a Scale
Standard Deviation 11.91
|
-14.40 Units on a Scale
Standard Deviation 13.13
|
-17.72 Units on a Scale
Standard Deviation 11.75
|
-22.08 Units on a Scale
Standard Deviation 10.12
|
|
Change From Baseline in CDAI Score Through Week 52
Week 20
|
-18.51 Units on a Scale
Standard Deviation 13.13
|
-21.55 Units on a Scale
Standard Deviation 11.42
|
-15.08 Units on a Scale
Standard Deviation 14.22
|
-19.31 Units on a Scale
Standard Deviation 12.30
|
-22.92 Units on a Scale
Standard Deviation 10.04
|
|
Change From Baseline in CDAI Score Through Week 52
Week 32
|
-20.52 Units on a Scale
Standard Deviation 12.07
|
-23.30 Units on a Scale
Standard Deviation 11.53
|
-16.46 Units on a Scale
Standard Deviation 14.45
|
-20.17 Units on a Scale
Standard Deviation 13.87
|
-24.25 Units on a Scale
Standard Deviation 10.38
|
|
Change From Baseline in CDAI Score Through Week 52
Week 36
|
-20.03 Units on a Scale
Standard Deviation 12.22
|
-23.58 Units on a Scale
Standard Deviation 11.41
|
-19.48 Units on a Scale
Standard Deviation 12.86
|
-20.83 Units on a Scale
Standard Deviation 13.10
|
-24.30 Units on a Scale
Standard Deviation 10.86
|
|
Change From Baseline in CDAI Score Through Week 52
Week 40
|
-20.41 Units on a Scale
Standard Deviation 12.12
|
-23.76 Units on a Scale
Standard Deviation 12.03
|
-19.00 Units on a Scale
Standard Deviation 13.77
|
-21.86 Units on a Scale
Standard Deviation 14.11
|
-24.87 Units on a Scale
Standard Deviation 10.76
|
|
Change From Baseline in CDAI Score Through Week 52
Week 52
|
-20.05 Units on a Scale
Standard Deviation 11.94
|
-24.93 Units on a Scale
Standard Deviation 11.90
|
-21.44 Units on a Scale
Standard Deviation 12.72
|
-23.67 Units on a Scale
Standard Deviation 13.42
|
-25.17 Units on a Scale
Standard Deviation 11.14
|
|
Change From Baseline in CDAI Score Through Week 52
EOT
|
-17.82 Units on a Scale
Standard Deviation 14.69
|
-23.12 Units on a Scale
Standard Deviation 12.04
|
-17.96 Units on a Scale
Standard Deviation 15.14
|
-21.39 Units on a Scale
Standard Deviation 14.85
|
-23.52 Units on a Scale
Standard Deviation 11.45
|
SECONDARY outcome
Timeframe: Baseline and Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
The investigator assessed the participants' disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment.
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Physician's Global Assessment of Arthritis (PGA) at Week 12
|
-13.94 Units on a Scale
Standard Deviation 24.85
|
-27.69 Units on a Scale
Standard Deviation 25.39
|
-34.65 Units on a Scale
Standard Deviation 21.19
|
-37.40 Units on a Scale
Standard Deviation 20.69
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
The investigator assessed the participants' disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in PGA Through Week 52
Week 8
|
-25.92 units on a scale
Standard Deviation 23.49
|
-30.55 units on a scale
Standard Deviation 21.05
|
-11.70 units on a scale
Standard Deviation 20.42
|
-16.04 units on a scale
Standard Deviation 22.64
|
-33.80 units on a scale
Standard Deviation 19.61
|
|
Change From Baseline in PGA Through Week 52
Week 12
|
-28.91 units on a scale
Standard Deviation 25.08
|
-35.53 units on a scale
Standard Deviation 21.28
|
-14.85 units on a scale
Standard Deviation 24.59
|
-18.99 units on a scale
Standard Deviation 23.44
|
-37.99 units on a scale
Standard Deviation 20.16
|
|
Change From Baseline in PGA Through Week 52
Week 16
|
-34.84 units on a scale
Standard Deviation 23.77
|
-34.68 units on a scale
Standard Deviation 22.76
|
-26.10 units on a scale
Standard Deviation 22.44
|
-31.35 units on a scale
Standard Deviation 20.54
|
-39.20 units on a scale
Standard Deviation 20.77
|
|
Change From Baseline in PGA Through Week 52
Week 20
|
-34.83 units on a scale
Standard Deviation 24.45
|
-38.65 units on a scale
Standard Deviation 21.19
|
-28.43 units on a scale
Standard Deviation 22.91
|
-33.80 units on a scale
Standard Deviation 21.18
|
-41.10 units on a scale
Standard Deviation 20.77
|
|
Change From Baseline in PGA Through Week 52
Week 24
|
-36.67 units on a scale
Standard Deviation 23.23
|
-38.50 units on a scale
Standard Deviation 23.05
|
-30.62 units on a scale
Standard Deviation 21.72
|
-37.43 units on a scale
Standard Deviation 21.86
|
-41.18 units on a scale
Standard Deviation 20.68
|
|
Change From Baseline in PGA Through Week 52
Week 28
|
-37.17 units on a scale
Standard Deviation 22.57
|
-39.29 units on a scale
Standard Deviation 21.74
|
-31.69 units on a scale
Standard Deviation 24.41
|
-37.90 units on a scale
Standard Deviation 22.50
|
-41.51 units on a scale
Standard Deviation 20.87
|
|
Change From Baseline in PGA Through Week 52
Week 32
|
-39.14 units on a scale
Standard Deviation 22.04
|
-40.49 units on a scale
Standard Deviation 21.08
|
-30.22 units on a scale
Standard Deviation 21.37
|
-37.27 units on a scale
Standard Deviation 23.10
|
-41.95 units on a scale
Standard Deviation 20.76
|
|
Change From Baseline in PGA Through Week 52
Week 40
|
-39.95 units on a scale
Standard Deviation 23.16
|
-41.88 units on a scale
Standard Deviation 21.29
|
-36.31 units on a scale
Standard Deviation 23.59
|
-38.83 units on a scale
Standard Deviation 22.58
|
-42.93 units on a scale
Standard Deviation 20.16
|
|
Change From Baseline in PGA Through Week 52
Week 44
|
-38.53 units on a scale
Standard Deviation 22.64
|
-42.16 units on a scale
Standard Deviation 21.19
|
-38.01 units on a scale
Standard Deviation 23.72
|
-37.74 units on a scale
Standard Deviation 23.46
|
-42.65 units on a scale
Standard Deviation 20.13
|
|
Change From Baseline in PGA Through Week 52
Week 48
|
-38.29 units on a scale
Standard Deviation 22.29
|
-43.41 units on a scale
Standard Deviation 20.74
|
-39.09 units on a scale
Standard Deviation 20.99
|
-41.99 units on a scale
Standard Deviation 22.00
|
-43.71 units on a scale
Standard Deviation 20.63
|
|
Change From Baseline in PGA Through Week 52
EOT
|
-34.09 units on a scale
Standard Deviation 25.92
|
-40.56 units on a scale
Standard Deviation 22.93
|
-33.01 units on a scale
Standard Deviation 25.17
|
-39.28 units on a scale
Standard Deviation 24.37
|
-41.07 units on a scale
Standard Deviation 22.71
|
|
Change From Baseline in PGA Through Week 52
Week 4
|
-18.71 units on a scale
Standard Deviation 17.32
|
-19.49 units on a scale
Standard Deviation 18.14
|
-8.77 units on a scale
Standard Deviation 17.97
|
-12.37 units on a scale
Standard Deviation 16.60
|
-27.48 units on a scale
Standard Deviation 20.10
|
|
Change From Baseline in PGA Through Week 52
Week 36
|
-38.29 units on a scale
Standard Deviation 23.55
|
-40.76 units on a scale
Standard Deviation 21.04
|
-35.44 units on a scale
Standard Deviation 22.26
|
-38.90 units on a scale
Standard Deviation 21.79
|
-41.27 units on a scale
Standard Deviation 21.41
|
|
Change From Baseline in PGA Through Week 52
Week 52
|
-37.85 units on a scale
Standard Deviation 23.45
|
-44.02 units on a scale
Standard Deviation 22.47
|
-39.43 units on a scale
Standard Deviation 21.85
|
-43.24 units on a scale
Standard Deviation 24.17
|
-44.11 units on a scale
Standard Deviation 20.69
|
SECONDARY outcome
Timeframe: Baseline and Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment.
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Subject's SGA at Week 12
|
-7.87 Units on a Scale
Standard Deviation 25.15
|
-23.74 Units on a Scale
Standard Deviation 32.14
|
-31.59 Units on a Scale
Standard Deviation 27.41
|
-32.43 Units on a Scale
Standard Deviation 27.39
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in SGA Through Week 52
Week 12
|
-25.09 units on a scale
Standard Deviation 31.56
|
-32.75 units on a scale
Standard Deviation 27.51
|
-6.93 units on a scale
Standard Deviation 22.74
|
-8.85 units on a scale
Standard Deviation 27.24
|
-33.14 units on a scale
Standard Deviation 27.23
|
|
Change From Baseline in SGA Through Week 52
Week 16
|
-29.98 units on a scale
Standard Deviation 30.36
|
-34.37 units on a scale
Standard Deviation 28.43
|
-21.29 units on a scale
Standard Deviation 24.56
|
-21.98 units on a scale
Standard Deviation 25.10
|
-34.88 units on a scale
Standard Deviation 25.91
|
|
Change From Baseline in SGA Through Week 52
Week 20
|
-29.82 units on a scale
Standard Deviation 32.87
|
-36.21 units on a scale
Standard Deviation 26.97
|
-17.76 units on a scale
Standard Deviation 26.75
|
-24.53 units on a scale
Standard Deviation 24.24
|
-36.10 units on a scale
Standard Deviation 26.28
|
|
Change From Baseline in SGA Through Week 52
Week 28
|
-31.19 units on a scale
Standard Deviation 33.76
|
-37.91 units on a scale
Standard Deviation 27.72
|
-25.66 units on a scale
Standard Deviation 27.71
|
-26.01 units on a scale
Standard Deviation 26.63
|
-37.75 units on a scale
Standard Deviation 26.52
|
|
Change From Baseline in SGA Through Week 52
Week 32
|
-34.49 units on a scale
Standard Deviation 30.49
|
-38.71 units on a scale
Standard Deviation 28.92
|
-27.97 units on a scale
Standard Deviation 28.37
|
-26.17 units on a scale
Standard Deviation 28.46
|
-38.02 units on a scale
Standard Deviation 27.74
|
|
Change From Baseline in SGA Through Week 52
Week 40
|
-34.66 units on a scale
Standard Deviation 32.19
|
-40.85 units on a scale
Standard Deviation 28.00
|
-30.76 units on a scale
Standard Deviation 27.65
|
-28.80 units on a scale
Standard Deviation 28.13
|
-38.42 units on a scale
Standard Deviation 26.72
|
|
Change From Baseline in SGA Through Week 52
Week 52
|
-35.61 units on a scale
Standard Deviation 33.45
|
-41.54 units on a scale
Standard Deviation 28.60
|
-32.06 units on a scale
Standard Deviation 28.15
|
-32.91 units on a scale
Standard Deviation 27.33
|
-40.36 units on a scale
Standard Deviation 27.01
|
|
Change From Baseline in SGA Through Week 52
EOT
|
-28.52 units on a scale
Standard Deviation 35.62
|
-38.84 units on a scale
Standard Deviation 29.05
|
-26.80 units on a scale
Standard Deviation 30.15
|
-28.71 units on a scale
Standard Deviation 27.54
|
-37.09 units on a scale
Standard Deviation 27.62
|
|
Change From Baseline in SGA Through Week 52
Week 4
|
-14.66 units on a scale
Standard Deviation 24.11
|
-18.30 units on a scale
Standard Deviation 24.25
|
-1.83 units on a scale
Standard Deviation 18.03
|
-6.59 units on a scale
Standard Deviation 21.35
|
-24.38 units on a scale
Standard Deviation 25.81
|
|
Change From Baseline in SGA Through Week 52
Week 8
|
-21.29 units on a scale
Standard Deviation 30.24
|
-29.55 units on a scale
Standard Deviation 26.34
|
-5.71 units on a scale
Standard Deviation 22.02
|
-8.78 units on a scale
Standard Deviation 21.39
|
-29.31 units on a scale
Standard Deviation 26.07
|
|
Change From Baseline in SGA Through Week 52
Week 24
|
-30.09 units on a scale
Standard Deviation 31.93
|
-37.51 units on a scale
Standard Deviation 29.32
|
-25.96 units on a scale
Standard Deviation 25.72
|
-25.42 units on a scale
Standard Deviation 26.02
|
-37.12 units on a scale
Standard Deviation 26.33
|
|
Change From Baseline in SGA Through Week 52
Week 36
|
-32.11 units on a scale
Standard Deviation 30.55
|
-39.08 units on a scale
Standard Deviation 26.81
|
-31.56 units on a scale
Standard Deviation 25.36
|
-26.64 units on a scale
Standard Deviation 26.00
|
-37.54 units on a scale
Standard Deviation 27.65
|
|
Change From Baseline in SGA Through Week 52
Week 44
|
-34.87 units on a scale
Standard Deviation 32.36
|
-39.51 units on a scale
Standard Deviation 29.51
|
-36.01 units on a scale
Standard Deviation 27.49
|
-28.19 units on a scale
Standard Deviation 26.52
|
-39.01 units on a scale
Standard Deviation 26.58
|
|
Change From Baseline in SGA Through Week 52
Week 48
|
-35.53 units on a scale
Standard Deviation 32.53
|
-41.60 units on a scale
Standard Deviation 27.74
|
-34.09 units on a scale
Standard Deviation 26.60
|
-31.05 units on a scale
Standard Deviation 27.81
|
-39.47 units on a scale
Standard Deviation 26.06
|
SECONDARY outcome
Timeframe: Baseline and Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
The participant assessed his/her own pain severity on a VAS from 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicate greater activity pain.
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Subject's Assessment of Pain at Week 12
|
-6.64 Units on a Scale
Standard Deviation 24.61
|
-23.78 Units on a Scale
Standard Deviation 30.75
|
-30.65 Units on a Scale
Standard Deviation 27.91
|
-30.82 Units on a Scale
Standard Deviation 27.68
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
The participant assessed his/her own pain severity on a VAS from 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicate greater activity pain.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Subject's Assessment of Pain Through Week 52
Week 8
|
-22.45 Units on a Scale
Standard Deviation 31.06
|
-29.58 Units on a Scale
Standard Deviation 26.18
|
-4.11 Units on a Scale
Standard Deviation 21.26
|
-9.17 Units on a Scale
Standard Deviation 22.75
|
-27.43 Units on a Scale
Standard Deviation 26.90
|
|
Change From Baseline in Subject's Assessment of Pain Through Week 52
Week 12
|
-25.02 Units on a Scale
Standard Deviation 30.64
|
-31.83 Units on a Scale
Standard Deviation 28.13
|
-5.40 Units on a Scale
Standard Deviation 24.28
|
-9.15 Units on a Scale
Standard Deviation 25.80
|
-31.37 Units on a Scale
Standard Deviation 27.66
|
|
Change From Baseline in Subject's Assessment of Pain Through Week 52
Week 16
|
-28.58 Units on a Scale
Standard Deviation 31.83
|
-34.41 Units on a Scale
Standard Deviation 27.22
|
-20.93 Units on a Scale
Standard Deviation 25.76
|
-21.20 Units on a Scale
Standard Deviation 23.95
|
-32.48 Units on a Scale
Standard Deviation 26.22
|
|
Change From Baseline in Subject's Assessment of Pain Through Week 52
Week 20
|
-29.68 Units on a Scale
Standard Deviation 32.42
|
-35.83 Units on a Scale
Standard Deviation 28.40
|
-16.21 Units on a Scale
Standard Deviation 28.27
|
-24.63 Units on a Scale
Standard Deviation 26.52
|
-34.76 Units on a Scale
Standard Deviation 26.53
|
|
Change From Baseline in Subject's Assessment of Pain Through Week 52
Week 24
|
-29.78 Units on a Scale
Standard Deviation 32.23
|
-37.78 Units on a Scale
Standard Deviation 28.87
|
-22.64 Units on a Scale
Standard Deviation 26.09
|
-26.51 Units on a Scale
Standard Deviation 25.46
|
-35.45 Units on a Scale
Standard Deviation 27.27
|
|
Change From Baseline in Subject's Assessment of Pain Through Week 52
Week 28
|
-31.66 Units on a Scale
Standard Deviation 31.61
|
-36.48 Units on a Scale
Standard Deviation 29.18
|
-22.63 Units on a Scale
Standard Deviation 28.92
|
-24.93 Units on a Scale
Standard Deviation 26.19
|
-36.23 Units on a Scale
Standard Deviation 27.15
|
|
Change From Baseline in Subject's Assessment of Pain Through Week 52
Week 36
|
-32.44 Units on a Scale
Standard Deviation 30.76
|
-38.48 Units on a Scale
Standard Deviation 27.27
|
-28.38 Units on a Scale
Standard Deviation 25.68
|
-26.79 Units on a Scale
Standard Deviation 25.38
|
-36.31 Units on a Scale
Standard Deviation 26.59
|
|
Change From Baseline in Subject's Assessment of Pain Through Week 52
Week 40
|
-35.06 Units on a Scale
Standard Deviation 31.74
|
-40.67 Units on a Scale
Standard Deviation 27.68
|
-26.65 Units on a Scale
Standard Deviation 28.10
|
-29.48 Units on a Scale
Standard Deviation 26.77
|
-36.45 Units on a Scale
Standard Deviation 26.58
|
|
Change From Baseline in Subject's Assessment of Pain Through Week 52
Week 48
|
-34.87 Units on a Scale
Standard Deviation 31.77
|
-40.27 Units on a Scale
Standard Deviation 28.71
|
-31.57 Units on a Scale
Standard Deviation 27.05
|
-30.73 Units on a Scale
Standard Deviation 27.45
|
-37.03 Units on a Scale
Standard Deviation 26.66
|
|
Change From Baseline in Subject's Assessment of Pain Through Week 52
Week 52
|
-33.24 Units on a Scale
Standard Deviation 34.91
|
-42.01 Units on a Scale
Standard Deviation 28.18
|
-29.57 Units on a Scale
Standard Deviation 26.98
|
-32.11 Units on a Scale
Standard Deviation 27.54
|
-38.47 Units on a Scale
Standard Deviation 26.45
|
|
Change From Baseline in Subject's Assessment of Pain Through Week 52
EOT
|
-28.49 Units on a Scale
Standard Deviation 34.27
|
-38.03 Units on a Scale
Standard Deviation 29.14
|
-24.18 Units on a Scale
Standard Deviation 28.11
|
-28.51 Units on a Scale
Standard Deviation 27.74
|
-35.47 Units on a Scale
Standard Deviation 27.47
|
|
Change From Baseline in Subject's Assessment of Pain Through Week 52
Week 4
|
-14.80 Units on a Scale
Standard Deviation 29.58
|
-18.36 Units on a Scale
Standard Deviation 24.49
|
-2.00 Units on a Scale
Standard Deviation 18.75
|
-8.23 Units on a Scale
Standard Deviation 25.32
|
-22.24 Units on a Scale
Standard Deviation 25.57
|
|
Change From Baseline in Subject's Assessment of Pain Through Week 52
Week 32
|
-34.15 Units on a Scale
Standard Deviation 30.84
|
-37.65 Units on a Scale
Standard Deviation 28.66
|
-25.53 Units on a Scale
Standard Deviation 27.07
|
-27.09 Units on a Scale
Standard Deviation 26.20
|
-37.20 Units on a Scale
Standard Deviation 27.18
|
|
Change From Baseline in Subject's Assessment of Pain Through Week 52
Week 44
|
-34.59 Units on a Scale
Standard Deviation 30.82
|
-38.76 Units on a Scale
Standard Deviation 29.25
|
-32.32 Units on a Scale
Standard Deviation 27.16
|
-28.55 Units on a Scale
Standard Deviation 25.32
|
-36.24 Units on a Scale
Standard Deviation 25.37
|
SECONDARY outcome
Timeframe: Up to week 12Population: Initial Randomization Set
The number of participants who withdrew due to lack of efficacy up to week 12 was calculated.
Outcome measures
| Measure |
Placebo
n=101 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=104 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=102 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants Who Withdrew Due to Lack of Efficacy
|
7 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
The HAQ-DI (range 0 - 3) was composed of 20 items in 8 categories (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities). Each category has at least two questions. Within each category, participants reported the amount of difficulty they have in performing the specific question items. Higher HAQ-DI score indicates greater disease activity.
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 12
|
0.03 Units on a Scale
Standard Deviation 0.55
|
-0.28 Units on a Scale
Standard Deviation 0.55
|
-0.37 Units on a Scale
Standard Deviation 0.50
|
-0.39 Units on a Scale
Standard Deviation 0.48
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS, number of participants with available data at each study visit.
The HAQ-DI (range 0 - 3) was composed of 20 items in 8 categories (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities). Each category has at least two questions. Within each category, participants reported the amount of difficulty they have in performing the specific question items. Higher HAQ-DI score indicates greater disease activity.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in HAQ-DI Through Week 52
Week 4
|
-0.10 units on a scale
Standard Deviation 0.35
|
-0.19 units on a scale
Standard Deviation 0.40
|
-0.04 units on a scale
Standard Deviation 0.32
|
0.01 units on a scale
Standard Deviation 0.38
|
-0.24 units on a scale
Standard Deviation 0.43
|
|
Change From Baseline in HAQ-DI Through Week 52
Week 8
|
-0.25 units on a scale
Standard Deviation 0.48
|
-0.31 units on a scale
Standard Deviation 0.48
|
-0.07 units on a scale
Standard Deviation 0.45
|
0.02 units on a scale
Standard Deviation 0.39
|
-0.35 units on a scale
Standard Deviation 0.45
|
|
Change From Baseline in HAQ-DI Through Week 52
Week 12
|
-0.30 units on a scale
Standard Deviation 0.55
|
-0.38 units on a scale
Standard Deviation 0.50
|
-0.09 units on a scale
Standard Deviation 0.55
|
0.03 units on a scale
Standard Deviation 0.50
|
-0.39 units on a scale
Standard Deviation 0.47
|
|
Change From Baseline in HAQ-DI Through Week 52
Week 16
|
-0.36 units on a scale
Standard Deviation 0.58
|
-0.41 units on a scale
Standard Deviation 0.48
|
-0.21 units on a scale
Standard Deviation 0.49
|
-0.12 units on a scale
Standard Deviation 0.48
|
-0.44 units on a scale
Standard Deviation 0.50
|
|
Change From Baseline in HAQ-DI Through Week 52
Week 20
|
-0.34 units on a scale
Standard Deviation 0.56
|
-0.46 units on a scale
Standard Deviation 0.53
|
-0.22 units on a scale
Standard Deviation 0.58
|
-0.21 units on a scale
Standard Deviation 0.47
|
-0.46 units on a scale
Standard Deviation 0.52
|
|
Change From Baseline in HAQ-DI Through Week 52
Week 24
|
-0.35 units on a scale
Standard Deviation 0.58
|
-0.46 units on a scale
Standard Deviation 0.53
|
-0.33 units on a scale
Standard Deviation 0.59
|
-0.26 units on a scale
Standard Deviation 0.45
|
-0.47 units on a scale
Standard Deviation 0.53
|
|
Change From Baseline in HAQ-DI Through Week 52
Week 28
|
-0.35 units on a scale
Standard Deviation 0.58
|
-0.49 units on a scale
Standard Deviation 0.59
|
-0.33 units on a scale
Standard Deviation 0.53
|
-0.23 units on a scale
Standard Deviation 0.49
|
-0.47 units on a scale
Standard Deviation 0.51
|
|
Change From Baseline in HAQ-DI Through Week 52
Week 32
|
-0.41 units on a scale
Standard Deviation 0.56
|
-0.50 units on a scale
Standard Deviation 0.54
|
-0.36 units on a scale
Standard Deviation 0.54
|
-0.29 units on a scale
Standard Deviation 0.46
|
-0.47 units on a scale
Standard Deviation 0.56
|
|
Change From Baseline in HAQ-DI Through Week 52
Week 36
|
-0.40 units on a scale
Standard Deviation 0.56
|
-0.50 units on a scale
Standard Deviation 0.58
|
-0.36 units on a scale
Standard Deviation 0.51
|
-0.25 units on a scale
Standard Deviation 0.52
|
-0.47 units on a scale
Standard Deviation 0.55
|
|
Change From Baseline in HAQ-DI Through Week 52
Week 40
|
-0.42 units on a scale
Standard Deviation 0.60
|
-0.51 units on a scale
Standard Deviation 0.57
|
-0.35 units on a scale
Standard Deviation 0.50
|
-0.28 units on a scale
Standard Deviation 0.47
|
-0.48 units on a scale
Standard Deviation 0.54
|
|
Change From Baseline in HAQ-DI Through Week 52
Week 48
|
-0.34 units on a scale
Standard Deviation 0.56
|
-0.52 units on a scale
Standard Deviation 0.57
|
-0.40 units on a scale
Standard Deviation 0.59
|
-0.31 units on a scale
Standard Deviation 0.50
|
-0.51 units on a scale
Standard Deviation 0.53
|
|
Change From Baseline in HAQ-DI Through Week 52
Week 52
|
-0.36 units on a scale
Standard Deviation 0.57
|
-0.54 units on a scale
Standard Deviation 0.56
|
-0.46 units on a scale
Standard Deviation 0.57
|
-0.29 units on a scale
Standard Deviation 0.51
|
-0.51 units on a scale
Standard Deviation 0.53
|
|
Change From Baseline in HAQ-DI Through Week 52
EOT
|
-0.30 units on a scale
Standard Deviation 0.60
|
-0.50 units on a scale
Standard Deviation 0.57
|
-0.37 units on a scale
Standard Deviation 0.64
|
-0.24 units on a scale
Standard Deviation 0.50
|
-0.47 units on a scale
Standard Deviation 0.53
|
|
Change From Baseline in HAQ-DI Through Week 52
Week 44
|
-0.39 units on a scale
Standard Deviation 0.58
|
-0.51 units on a scale
Standard Deviation 0.58
|
-0.42 units on a scale
Standard Deviation 0.63
|
-0.27 units on a scale
Standard Deviation 0.51
|
-0.49 units on a scale
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: Baseline and Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score at Week 12
|
1.95 Units on a Scale
Standard Deviation 12.20
|
8.36 Units on a Scale
Standard Deviation 14.05
|
8.81 Units on a Scale
Standard Deviation 10.54
|
8.53 Units on a Scale
Standard Deviation 10.61
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 4, 8, 12, 28, and 52Population: FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the SF-36 questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib.
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=200 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52
Week 4
|
3.82 Units on a Scale
Standard Deviation 10.21
|
3.20 Units on a Scale
Standard Deviation 10.49
|
6.10 Units on a Scale
Standard Deviation 10.07
|
—
|
—
|
|
Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52
Week 8
|
6.43 Units on a Scale
Standard Deviation 10.98
|
6.78 Units on a Scale
Standard Deviation 9.99
|
7.35 Units on a Scale
Standard Deviation 10.23
|
—
|
—
|
|
Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52
Week 12
|
9.93 Units on a Scale
Standard Deviation 12.38
|
9.63 Units on a Scale
Standard Deviation 10.33
|
8.40 Units on a Scale
Standard Deviation 10.51
|
—
|
—
|
|
Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52
Week 28
|
10.85 Units on a Scale
Standard Deviation 12.79
|
10.95 Units on a Scale
Standard Deviation 12.04
|
10.28 Units on a Scale
Standard Deviation 10.67
|
—
|
—
|
|
Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52
Week 52
|
13.07 Units on a Scale
Standard Deviation 12.41
|
9.88 Units on a Scale
Standard Deviation 12.51
|
11.18 Units on a Scale
Standard Deviation 11.77
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in SF-36v2 Mental Component Summary Score at Week 12
|
0.00 Units on a Scale
Standard Deviation 8.65
|
2.70 Units on a Scale
Standard Deviation 7.59
|
3.69 Units on a Scale
Standard Deviation 8.23
|
3.23 Units on a Scale
Standard Deviation 8.24
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 4, 8, 12, 28, and 52Population: FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the SF-36 questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib.
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=200 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52
Week 4
|
1.53 units on a scale
Standard Deviation 7.19
|
1.72 units on a scale
Standard Deviation 7.58
|
2.85 units on a scale
Standard Deviation 8.07
|
—
|
—
|
|
Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52
Week 8
|
2.91 units on a scale
Standard Deviation 7.39
|
3.55 units on a scale
Standard Deviation 9.08
|
3.56 units on a scale
Standard Deviation 8.49
|
—
|
—
|
|
Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52
Week 12
|
2.38 units on a scale
Standard Deviation 7.53
|
4.01 units on a scale
Standard Deviation 8.17
|
3.63 units on a scale
Standard Deviation 7.95
|
—
|
—
|
|
Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52
Week 28
|
2.95 units on a scale
Standard Deviation 8.07
|
3.52 units on a scale
Standard Deviation 8.14
|
3.80 units on a scale
Standard Deviation 7.66
|
—
|
—
|
|
Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52
Week 52
|
4.23 units on a scale
Standard Deviation 8.17
|
4.39 units on a scale
Standard Deviation 8.08
|
3.79 units on a scale
Standard Deviation 8.38
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in SF-36v2 Role/Social Component Summary Score at Week 12
|
0.17 Units on a Scale
Standard Deviation 15.12
|
1.24 Units on a Scale
Standard Deviation 14.40
|
7.04 Units on a Scale
Standard Deviation 14.56
|
7.16 Units on a Scale
Standard Deviation 13.23
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 4, 8, 12, 28, and 52Population: FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the SF-36 questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib.
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=200 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52
Week 8
|
3.80 Units on a Scale
Standard Deviation 13.23
|
5.96 Units on a Scale
Standard Deviation 14.60
|
6.51 Units on a Scale
Standard Deviation 12.54
|
—
|
—
|
|
Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52
Week 12
|
1.68 Units on a Scale
Standard Deviation 14.33
|
7.82 Units on a Scale
Standard Deviation 14.66
|
7.49 Units on a Scale
Standard Deviation 13.04
|
—
|
—
|
|
Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52
Week 52
|
3.88 Units on a Scale
Standard Deviation 15.12
|
9.15 Units on a Scale
Standard Deviation 13.39
|
8.36 Units on a Scale
Standard Deviation 14.03
|
—
|
—
|
|
Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52
Week 4
|
0.40 Units on a Scale
Standard Deviation 12.75
|
4.27 Units on a Scale
Standard Deviation 12.02
|
4.06 Units on a Scale
Standard Deviation 13.08
|
—
|
—
|
|
Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52
Week 28
|
4.18 Units on a Scale
Standard Deviation 14.21
|
8.78 Units on a Scale
Standard Deviation 14.20
|
7.31 Units on a Scale
Standard Deviation 14.74
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent work time missed due to problem: Q2/(Q2+Q4).
Outcome measures
| Measure |
Placebo
n=48 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=57 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=49 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=99 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed at Week 12
|
6.78 Percent Work Time
Standard Deviation 25.76
|
-2.14 Percent Work Time
Standard Deviation 18.47
|
-6.80 Percent Work Time
Standard Deviation 19.40
|
-5.60 Percent Work Time
Standard Deviation 20.63
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 4, 8, 12, 28, and 52Population: FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the WPAI questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib.
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent work time missed due to problem: Q2/(Q2+Q4).
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=200 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in WPAI Percent Work Time Missed Through Week 52
Week 4
|
-0.56 Percent Work Time
Standard Deviation 20.13
|
-6.35 Percent Work Time
Standard Deviation 15.94
|
-3.71 Percent Work Time
Standard Deviation 17.34
|
—
|
—
|
|
Change From Baseline in WPAI Percent Work Time Missed Through Week 52
Week 8
|
-2.38 Percent Work Time
Standard Deviation 16.15
|
-6.10 Percent Work Time
Standard Deviation 19.30
|
-4.33 Percent Work Time
Standard Deviation 15.57
|
—
|
—
|
|
Change From Baseline in WPAI Percent Work Time Missed Through Week 52
Week 28
|
-3.14 Percent Work Time
Standard Deviation 24.48
|
-6.46 Percent Work Time
Standard Deviation 20.29
|
-5.03 Percent Work Time
Standard Deviation 18.18
|
—
|
—
|
|
Change From Baseline in WPAI Percent Work Time Missed Through Week 52
Week 52
|
-6.76 Percent Work Time
Standard Deviation 22.20
|
-6.35 Percent Work Time
Standard Deviation 16.57
|
-4.52 Percent Work Time
Standard Deviation 14.91
|
—
|
—
|
|
Change From Baseline in WPAI Percent Work Time Missed Through Week 52
Week 12
|
-1.38 Percent Work Time
Standard Deviation 18.13
|
-6.69 Percent Work Time
Standard Deviation 19.78
|
-4.73 Percent Work Time
Standard Deviation 18.54
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=56 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=49 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=97 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in WPAI Percent Impairment While Working at Week 12
|
4.13 Percent Impairment
Standard Deviation 30.15
|
-13.04 Percent Impairment
Standard Deviation 30.45
|
-16.12 Percent Impairment
Standard Deviation 31.94
|
-24.43 Percent Impairment
Standard Deviation 25.82
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 4, 8, 12, 28, and 52Population: FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the WPAI questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib.
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=200 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in WPAI Percent Impairment While Working Through Week 52
Week 4
|
-6.42 percent impairment
Standard Deviation 22.28
|
-6.46 percent impairment
Standard Deviation 27.48
|
-18.33 percent impairment
Standard Deviation 26.34
|
—
|
—
|
|
Change From Baseline in WPAI Percent Impairment While Working Through Week 52
Week 8
|
-14.31 percent impairment
Standard Deviation 26.10
|
-15.42 percent impairment
Standard Deviation 27.75
|
-20.52 percent impairment
Standard Deviation 25.31
|
—
|
—
|
|
Change From Baseline in WPAI Percent Impairment While Working Through Week 52
Week 12
|
-13.33 percent impairment
Standard Deviation 30.96
|
-19.77 percent impairment
Standard Deviation 31.66
|
-24.11 percent impairment
Standard Deviation 25.95
|
—
|
—
|
|
Change From Baseline in WPAI Percent Impairment While Working Through Week 52
Week 28
|
-17.35 percent impairment
Standard Deviation 34.63
|
-25.85 percent impairment
Standard Deviation 28.10
|
-29.53 percent impairment
Standard Deviation 26.78
|
—
|
—
|
|
Change From Baseline in WPAI Percent Impairment While Working Through Week 52
Week 52
|
-20.79 percent impairment
Standard Deviation 36.27
|
-23.89 percent impairment
Standard Deviation 30.55
|
-31.36 percent impairment
Standard Deviation 31.18
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent overall work impairment due to problem: Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\].
Outcome measures
| Measure |
Placebo
n=46 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=55 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=49 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=97 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in Percent Overall Work Impairment at Week 12
|
3.62 Percent iImpairment
Standard Deviation 30.49
|
-12.20 Percent iImpairment
Standard Deviation 31.39
|
-18.68 Percent iImpairment
Standard Deviation 33.81
|
-24.68 Percent iImpairment
Standard Deviation 26.54
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 4, 8, 12, 28, and 52Population: FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the WPAI questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib.
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent overall work impairment due to problem: Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\].
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=200 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52
Week 8
|
-14.16 Percent Impairment
Standard Deviation 27.22
|
-17.44 Percent Impairment
Standard Deviation 29.05
|
-20.94 Percent Impairment
Standard Deviation 25.88
|
—
|
—
|
|
Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52
Week 12
|
-13.16 Percent Impairment
Standard Deviation 32.11
|
-22.84 Percent Impairment
Standard Deviation 33.22
|
-25.35 Percent Impairment
Standard Deviation 26.68
|
—
|
—
|
|
Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52
Week 28
|
-17.48 Percent Impairment
Standard Deviation 34.87
|
-28.68 Percent Impairment
Standard Deviation 29.66
|
-30.12 Percent Impairment
Standard Deviation 28.21
|
—
|
—
|
|
Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52
Week 52
|
-21.53 Percent Impairment
Standard Deviation 35.95
|
-24.75 Percent Impairment
Standard Deviation 31.45
|
-32.18 Percent Impairment
Standard Deviation 31.81
|
—
|
—
|
|
Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52
Week 4
|
-5.72 Percent Impairment
Standard Deviation 21.61
|
-8.67 Percent Impairment
Standard Deviation 28.20
|
-18.20 Percent Impairment
Standard Deviation 26.96
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12/ETPopulation: FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent activity impairment due to problem: Q6/10.
Outcome measures
| Measure |
Placebo
n=99 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=101 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in WPAI Percent Activity Impairment at Week 12
|
-4.65 Percent Impairment
Standard Deviation 26.39
|
-19.61 Percent Impairment
Standard Deviation 29.62
|
-24.65 Percent Impairment
Standard Deviation 28.27
|
-26.40 Percent Impairment
Standard Deviation 24.50
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 4, 8, 12, 28, and 52Population: FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the WPAI questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib.
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent activity impairment due to problem: Q6/10.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=102 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=200 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Change From Baseline in WPAI Percent Activity Impairment Through Week 52
Week 4
|
-10.92 percent impairment
Standard Deviation 24.75
|
-11.30 percent impairment
Standard Deviation 21.82
|
-17.90 percent impairment
Standard Deviation 23.11
|
—
|
—
|
|
Change From Baseline in WPAI Percent Activity Impairment Through Week 52
Week 8
|
-20.10 percent impairment
Standard Deviation 26.89
|
-23.64 percent impairment
Standard Deviation 26.05
|
-25.33 percent impairment
Standard Deviation 23.95
|
—
|
—
|
|
Change From Baseline in WPAI Percent Activity Impairment Through Week 52
Week 12
|
-21.47 percent impairment
Standard Deviation 29.53
|
-26.74 percent impairment
Standard Deviation 28.48
|
-27.33 percent impairment
Standard Deviation 23.90
|
—
|
—
|
|
Change From Baseline in WPAI Percent Activity Impairment Through Week 52
Week 28
|
-25.18 percent impairment
Standard Deviation 31.40
|
-30.00 percent impairment
Standard Deviation 27.80
|
-30.34 percent impairment
Standard Deviation 26.86
|
—
|
—
|
|
Change From Baseline in WPAI Percent Activity Impairment Through Week 52
Week 52
|
-28.17 percent impairment
Standard Deviation 30.01
|
-34.07 percent impairment
Standard Deviation 27.69
|
-31.79 percent impairment
Standard Deviation 26.96
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 to Week 12Population: SAF
Treatment-emergent adverse events (TEAEs) were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by System Organ Class (SOC) and Preferred Term (PT). Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE.
Outcome measures
| Measure |
Placebo
n=101 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=104 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=102 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=200 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events During the First 12 Weeks
TEAEs
|
54 Participants
|
49 Participants
|
55 Participants
|
119 Participants
|
—
|
|
Number of Participants With Adverse Events During the First 12 Weeks
Drug-related TEAEs
|
29 Participants
|
33 Participants
|
38 Participants
|
75 Participants
|
—
|
|
Number of Participants With Adverse Events During the First 12 Weeks
TEAEs leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Adverse Events During the First 12 Weeks
Serious TEAEs
|
4 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
—
|
|
Number of Participants With Adverse Events During the First 12 Weeks
Drug-related serious TEAEs
|
3 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
—
|
|
Number of Participants With Adverse Events During the First 12 Weeks
≥ Grade 3 TEAEs
|
8 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
—
|
|
Number of Participants With Adverse Events During the First 12 Weeks
TEAEs leading to discontinuation
|
4 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
—
|
|
Number of Participants With Adverse Events During the First 12 Weeks
Drug-related TEAEs leading to discontinuation
|
1 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
—
|
|
Number of Participants With Adverse Events During the First 12 Weeks
Serious TEAEs leading to discontinuation
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Number of Participants With Adverse Events During the First 12 Weeks
Drug-related serious TEAEs leading to discont.
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension studyPopulation: SAF
Treatment-emergent adverse events (TEAEs) were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE.
Outcome measures
| Measure |
Placebo
n=96 Participants
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Peficitinib 100 mg
n=93 Participants
Participants were assigned to receive peficitinib 100 mg/day for 52 weeks.
|
Peficitinib 150 mg
n=43 Participants
Participants were assigned to receive peficitinib 150 mg/day for 52 weeks.
|
Etanercept
n=47 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
Etanercept
n=191 Participants
Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events From Week 12
Drug-related TEAEs
|
50 Participants
|
47 Participants
|
27 Participants
|
26 Participants
|
93 Participants
|
|
Number of Participants With Adverse Events From Week 12
TEAEs leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events From Week 12
Serious TEAEs
|
5 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
14 Participants
|
|
Number of Participants With Adverse Events From Week 12
TEAEs
|
78 Participants
|
79 Participants
|
41 Participants
|
37 Participants
|
156 Participants
|
|
Number of Participants With Adverse Events From Week 12
Drug-related serious TEAEs
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events From Week 12
≥ Grade 3 TEAEs
|
9 Participants
|
16 Participants
|
2 Participants
|
12 Participants
|
23 Participants
|
|
Number of Participants With Adverse Events From Week 12
TEAEs leading to discontinuation
|
7 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
8 Participants
|
|
Number of Participants With Adverse Events From Week 12
Drug-related TEAEs leading to discontinuation
|
3 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events From Week 12
Serious TEAEs leading to discontinuation
|
4 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events From Week 12
Drug-related serious TEAEs leading to discont.
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
Weeks 0-12: Placebo
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
Weeks 0-12: Peficitinib 100 mg
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Weeks 0-12: Peficitinib 150 mg
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
Weeks 0-12: Etanercept
Serious events: 4 serious events
Other events: 63 other events
Deaths: 0 deaths
Weeks 12-52: Peficitinib 100 mg
Serious events: 5 serious events
Other events: 50 other events
Deaths: 0 deaths
Weeks 12-52: Peficitinib 150 mg
Serious events: 6 serious events
Other events: 42 other events
Deaths: 0 deaths
Weeks 12-52: Placebo / Peficitinib 100 mg
Serious events: 4 serious events
Other events: 28 other events
Deaths: 0 deaths
Weeks 12-52: Placebo / Peficitinib 150 mg
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
Weeks 12-52: Etanercept
Serious events: 14 serious events
Other events: 94 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Weeks 0-12: Placebo
n=101 participants at risk
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Weeks 0-12: Peficitinib 100 mg
n=104 participants at risk
Participants were assigned to receive peficitinib 100 mg/day until 12 weeks.
|
Weeks 0-12: Peficitinib 150 mg
n=102 participants at risk
Participants were assigned to receive peficitinib 150 mg/day until 12 weeks.
|
Weeks 0-12: Etanercept
n=200 participants at risk
Participants were administered 50 mg of subcutaneous etanercept once weekly until 12 weeks.
|
Weeks 12-52: Peficitinib 100 mg
n=96 participants at risk
Participants were assigned to receive peficitinib 100 mg/day until 12 weeks and from week 12 to week 52.
|
Weeks 12-52: Peficitinib 150 mg
n=93 participants at risk
Participants were assigned to receive peficitinib 150 mg/day until 12 weeks and from week 12 to week 52.
|
Weeks 12-52: Placebo / Peficitinib 100 mg
n=43 participants at risk
Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52.
|
Weeks 12-52: Placebo / Peficitinib 150 mg
n=47 participants at risk
Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 150 mg/day from week 12 to week 52.
|
Weeks 12-52: Etanercept
n=191 participants at risk
Participants were administered 50 mg of subcutaneous etanercept once weekly until 12 weeks and from week 12 to week 52.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.99%
1/101 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Blood and lymphatic system disorders
Hypereosinophilic syndrome
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.50%
1/200 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.99%
1/101 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Ear and labyrinth disorders
Vertigo
|
0.99%
1/101 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.1%
1/93 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.1%
1/47 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.3%
1/43 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.96%
1/104 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.0%
1/96 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.1%
1/47 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
General disorders
Malaise
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.96%
1/104 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.50%
1/200 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.52%
1/191 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.1%
1/93 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.1%
1/93 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Infections and infestations
Eczema herpeticum
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.3%
1/43 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.52%
1/191 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.1%
1/93 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.52%
1/191 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.98%
1/102 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.50%
1/200 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.1%
1/47 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.52%
1/191 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.0%
1/96 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.98%
1/102 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.52%
1/191 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.52%
1/191 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.0%
1/96 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.2%
2/93 • Number of events 2 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.99%
1/101 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Investigations
Bronchoscopy
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.1%
1/93 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.1%
1/93 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.52%
1/191 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.50%
1/200 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.99%
1/101 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.96%
1/104 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.52%
1/191 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.3%
1/43 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.0%
1/96 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.0%
1/96 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.52%
1/191 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Nervous system disorders
Migraine
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.52%
1/191 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.1%
1/47 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.0%
1/96 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.50%
1/200 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.0%
2/191 • Number of events 2 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Social circumstances
Social stay hospitalisation
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.1%
1/47 • Number of events 2 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.0%
2/191 • Number of events 2 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Surgical and medical procedures
Prostatectomy
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.3%
1/43 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Vascular disorders
Hypertension
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.3%
1/43 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/191 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
Other adverse events
| Measure |
Weeks 0-12: Placebo
n=101 participants at risk
Participants were assigned to receive placebo to peficitinib once a day until week 12.
|
Weeks 0-12: Peficitinib 100 mg
n=104 participants at risk
Participants were assigned to receive peficitinib 100 mg/day until 12 weeks.
|
Weeks 0-12: Peficitinib 150 mg
n=102 participants at risk
Participants were assigned to receive peficitinib 150 mg/day until 12 weeks.
|
Weeks 0-12: Etanercept
n=200 participants at risk
Participants were administered 50 mg of subcutaneous etanercept once weekly until 12 weeks.
|
Weeks 12-52: Peficitinib 100 mg
n=96 participants at risk
Participants were assigned to receive peficitinib 100 mg/day until 12 weeks and from week 12 to week 52.
|
Weeks 12-52: Peficitinib 150 mg
n=93 participants at risk
Participants were assigned to receive peficitinib 150 mg/day until 12 weeks and from week 12 to week 52.
|
Weeks 12-52: Placebo / Peficitinib 100 mg
n=43 participants at risk
Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52.
|
Weeks 12-52: Placebo / Peficitinib 150 mg
n=47 participants at risk
Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 150 mg/day from week 12 to week 52.
|
Weeks 12-52: Etanercept
n=191 participants at risk
Participants were administered 50 mg of subcutaneous etanercept once weekly until 12 weeks and from week 12 to week 52.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.50%
1/200 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
3.1%
3/96 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.2%
2/93 • Number of events 2 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
7.0%
3/43 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.1%
1/47 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.6%
3/191 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Gastrointestinal disorders
Stomatitis
|
2.0%
2/101 • Number of events 2 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.9%
2/104 • Number of events 2 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
3.9%
4/102 • Number of events 4 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.0%
4/200 • Number of events 4 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
3.1%
3/96 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.1%
1/93 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.3%
1/43 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
6.4%
3/47 • Number of events 4 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.6%
3/191 • Number of events 4 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
General disorders
Injection site reaction
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
12.5%
25/200 • Number of events 77 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
4.7%
9/191 • Number of events 63 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
3.0%
3/101 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
6.9%
7/102 • Number of events 7 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
4.5%
9/200 • Number of events 9 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.1%
2/96 • Number of events 2 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.2%
2/93 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
4.7%
2/43 • Number of events 2 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.6%
3/191 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Infections and infestations
Bronchitis
|
0.99%
1/101 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
3.8%
4/104 • Number of events 4 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.98%
1/102 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.50%
1/200 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
4.2%
4/96 • Number of events 5 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.3%
1/43 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
10.6%
5/47 • Number of events 5 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
3.7%
7/191 • Number of events 7 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.98%
1/102 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.50%
1/200 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.0%
1/96 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.2%
2/93 • Number of events 2 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
7.0%
3/43 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.6%
5/191 • Number of events 5 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.96%
1/104 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.0%
2/200 • Number of events 2 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
4.2%
4/96 • Number of events 4 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
4.3%
4/93 • Number of events 4 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
9.3%
4/43 • Number of events 4 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.1%
1/47 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.6%
3/191 • Number of events 6 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Infections and infestations
Influenza
|
2.0%
2/101 • Number of events 2 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.9%
3/104 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.98%
1/102 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.0%
2/200 • Number of events 2 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
4.2%
4/96 • Number of events 4 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
5.4%
5/93 • Number of events 5 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
4.7%
2/43 • Number of events 2 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
4.3%
2/47 • Number of events 2 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
4.2%
8/191 • Number of events 8 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
6/101 • Number of events 6 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
9.6%
10/104 • Number of events 11 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
18.6%
19/102 • Number of events 19 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
8.0%
16/200 • Number of events 17 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
21.9%
21/96 • Number of events 30 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
16.1%
15/93 • Number of events 21 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
30.2%
13/43 • Number of events 18 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
17.0%
8/47 • Number of events 11 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
25.7%
49/191 • Number of events 77 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Infections and infestations
Pharyngitis
|
0.99%
1/101 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.96%
1/104 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.98%
1/102 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.0%
4/200 • Number of events 5 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
7.3%
7/96 • Number of events 11 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
3.2%
3/93 • Number of events 4 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
8.5%
4/47 • Number of events 4 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
3.1%
6/191 • Number of events 7 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
2/101 • Number of events 2 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.9%
3/104 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.9%
3/102 • Number of events 4 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.5%
3/200 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
3.1%
3/96 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
4.3%
4/93 • Number of events 5 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
9.3%
4/43 • Number of events 4 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
10.6%
5/47 • Number of events 7 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.6%
3/191 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/101 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
3.8%
4/104 • Number of events 4 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
3.9%
4/102 • Number of events 4 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.50%
1/200 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
6.2%
6/96 • Number of events 9 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
7.5%
7/93 • Number of events 7 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
7.0%
3/43 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
6.4%
3/47 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.1%
4/191 • Number of events 4 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.99%
1/101 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/104 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/102 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/200 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/96 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/93 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/43 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
6.4%
3/47 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.52%
1/191 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
9.9%
10/101 • Number of events 17 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.9%
2/104 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.0%
2/102 • Number of events 12 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.5%
3/200 • Number of events 4 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
3.1%
3/96 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
3.2%
3/93 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
4.7%
2/43 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
4.2%
8/191 • Number of events 10 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
4/101 • Number of events 4 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.96%
1/104 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.9%
3/102 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.0%
2/200 • Number of events 2 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
5.2%
5/96 • Number of events 5 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
4.3%
4/93 • Number of events 5 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.3%
1/43 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
6.4%
3/47 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
4.2%
8/191 • Number of events 8 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.99%
1/101 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.9%
2/104 • Number of events 2 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.9%
3/102 • Number of events 4 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
1.5%
3/200 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
3.1%
3/96 • Number of events 3 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
5.4%
5/93 • Number of events 5 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
2.3%
1/43 • Number of events 1 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
0.00%
0/47 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
4.7%
9/191 • Number of events 10 • Week 0 to week 12, and from week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study.
The safety analysis set (SAF) consisted of all participants who received at least one dose of study drugs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER