Trial Outcomes & Findings for A Study for Japanese Participants With Rheumatoid Arthritis (RA) (NCT NCT01253226)
NCT ID: NCT01253226
Last Updated: 2018-10-23
Results Overview
Clinically significant effects are defined as serious AEs (SAEs) and other non-serious AEs regardless of causality. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
Results posted on
2018-10-23
Participant Flow
This dose-escalation study had 4 cohorts. Each cohort included 6 LY2127399 (tabalumab) participants and 2 placebo participants. Participants treated once every 2 weeks (Q2W) or once every 4 weeks (Q4W) and had a follow-up visit at Week 32. Additional visits beyond Week 32 were scheduled, as needed, for B cell count monitoring (up to 12 weeks).
Participant milestones
| Measure |
30 mg Tabalumab Q4W
Tabalumab: 30 milligrams (mg) subcutaneous (SC) injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
60 mg Tabalumab Q4W
Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q4W
Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q2W
Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
Placebo
Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
8
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
6
|
6
|
6
|
6
|
8
|
|
Overall Study
COMPLETED
|
6
|
5
|
5
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
30 mg Tabalumab Q4W
Tabalumab: 30 milligrams (mg) subcutaneous (SC) injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
60 mg Tabalumab Q4W
Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q4W
Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q2W
Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
Placebo
Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study for Japanese Participants With Rheumatoid Arthritis (RA)
Baseline characteristics by cohort
| Measure |
30 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 30 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
60 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q2W
n=6 Participants
Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
Placebo
n=8 Participants
Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.0 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
50.0 years
STANDARD_DEVIATION 15.0 • n=7 Participants
|
55.5 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
56.7 years
STANDARD_DEVIATION 8.0 • n=4 Participants
|
58.4 years
STANDARD_DEVIATION 17.1 • n=21 Participants
|
57.4 years
STANDARD_DEVIATION 13.3 • n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
|
Region of Enrollment
Japan
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
|
Current Use of Corticosteroids
Yes
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Current Use of Corticosteroids
No
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
|
Body Weight
|
54.8 kilograms (kg)
STANDARD_DEVIATION 5.5 • n=5 Participants
|
55.9 kilograms (kg)
STANDARD_DEVIATION 13.8 • n=7 Participants
|
55.9 kilograms (kg)
STANDARD_DEVIATION 10.5 • n=5 Participants
|
58.3 kilograms (kg)
STANDARD_DEVIATION 8.3 • n=4 Participants
|
54.6 kilograms (kg)
STANDARD_DEVIATION 7.5 • n=21 Participants
|
55.8 kilograms (kg)
STANDARD_DEVIATION 8.9 • n=8 Participants
|
|
C-Reactive Protein (CRP)
|
11.46 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 13.90 • n=5 Participants
|
18.69 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 35.23 • n=7 Participants
|
14.91 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 9.17 • n=5 Participants
|
8.73 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 8.26 • n=4 Participants
|
11.07 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 5.30 • n=21 Participants
|
12.85 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 16.56 • n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)Population: Randomized participants who received at least 1 dose of study drug (tabalumab or placebo).
Clinically significant effects are defined as serious AEs (SAEs) and other non-serious AEs regardless of causality. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
30 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 30 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
60 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q2W
n=6 Participants
Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
Placebo
n=8 Participants
Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) [Clinically Significant Effects]
SAEs, all causes
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) [Clinically Significant Effects]
Non-Serious AEs, all causes
|
5 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 0: Day 1 [predose and 1 hour (h), 3 h, and 6 h postdose], Days 2, 3, and 5, and Weeks 1, 2, 3, and 4 postdosePopulation: Randomized participants who received at least 1 dose of tabalumab and had evaluable AUC data.
The following parameters are reported for the first SC injection of tabalumab: AUC(0-tlast) defined as AUC from time 0 to time t, where t is the time at the end of the dosing interval; AUC(0-2W) defined as AUC from time 0 to Week 2; and AUC(0-tau) defined as AUC during 1 dosing interval at steady state.
Outcome measures
| Measure |
30 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 30 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
60 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q2W
n=6 Participants
Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
Placebo
Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK) of Tabalumab: Area Under the Concentration Time Curve (AUC)
AUC(0-tlast)
|
57.0 micrograms*day/milliliter (mcg*day/mL)
Geometric Coefficient of Variation 24
|
148 micrograms*day/milliliter (mcg*day/mL)
Geometric Coefficient of Variation 38
|
303 micrograms*day/milliliter (mcg*day/mL)
Geometric Coefficient of Variation 49
|
303 micrograms*day/milliliter (mcg*day/mL)
Geometric Coefficient of Variation 30
|
—
|
|
Pharmacokinetics (PK) of Tabalumab: Area Under the Concentration Time Curve (AUC)
AUC(0-2W)
|
30.3 micrograms*day/milliliter (mcg*day/mL)
Geometric Coefficient of Variation 26
|
86.5 micrograms*day/milliliter (mcg*day/mL)
Geometric Coefficient of Variation 34
|
170 micrograms*day/milliliter (mcg*day/mL)
Geometric Coefficient of Variation 46
|
280 micrograms*day/milliliter (mcg*day/mL)
Geometric Coefficient of Variation 35
|
—
|
|
Pharmacokinetics (PK) of Tabalumab: Area Under the Concentration Time Curve (AUC)
AUC(0-tau)
|
55.5 micrograms*day/milliliter (mcg*day/mL)
Geometric Coefficient of Variation 27
|
173 micrograms*day/milliliter (mcg*day/mL)
Geometric Coefficient of Variation NA
Only 1 participant included in the analysis, therefore the geometric coefficient of variation is not calculable.
|
260 micrograms*day/milliliter (mcg*day/mL)
Geometric Coefficient of Variation 58
|
280 micrograms*day/milliliter (mcg*day/mL)
Geometric Coefficient of Variation 35
|
—
|
SECONDARY outcome
Timeframe: Week 0: Day 1 Predose, 1 h, 3 h, and 6 h postdosePopulation: Randomized participants who received at least 1 dose of tabalumab and had evaluable Cmax data.
Cmax for the first SC injection of tabalumab is reported.
Outcome measures
| Measure |
30 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 30 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
60 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q2W
n=6 Participants
Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
Placebo
Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
|---|---|---|---|---|---|
|
PK of Tabalumab: Maximum Observed Drug Concentration (Cmax)
|
2.88 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 26
|
7.61 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 35
|
16.6 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 61
|
25.0 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 28
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 0 (Day 2), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, and 32Population: Randomized participants who received at least 1 dose of study drug (tabalumab or placebo) and had a baseline and at least 1 post-baseline B cell assessment.
B-lymphocyte antigen, CD20+, is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Percent change from baseline in B cell counts=\[(post-baseline CD20+ B cell count-baseline CD20+ B cell count)/(baseline CD20+ B cell count)\]\*100. A negative change indicates a decrease in cell count.
Outcome measures
| Measure |
30 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 30 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
60 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q2W
n=5 Participants
Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
Placebo
n=7 Participants
Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in B Cell [Cluster Designation 20+ (CD20+)] Counts
Week 16
|
-24.7 percent change
Standard Deviation 32.4
|
-37.9 percent change
Standard Deviation 27.1
|
27.0 percent change
Standard Deviation 74.1
|
-8.3 percent change
Standard Deviation 29.2
|
0.6 percent change
Standard Deviation 35.2
|
|
Percent Change From Baseline in B Cell [Cluster Designation 20+ (CD20+)] Counts
Week 0 (Day 2)
|
13.7 percent change
Standard Deviation 20.7
|
15.6 percent change
Standard Deviation 60.0
|
16.1 percent change
Standard Deviation 22.5
|
13.7 percent change
Standard Deviation 34.4
|
34.9 percent change
Standard Deviation 49.9
|
|
Percent Change From Baseline in B Cell [Cluster Designation 20+ (CD20+)] Counts
Week 1
|
42.8 percent change
Standard Deviation 25.8
|
82.1 percent change
Standard Deviation 107.8
|
100.7 percent change
Standard Deviation 91.2
|
55.3 percent change
Standard Deviation 53.9
|
-7.2 percent change
Standard Deviation 8.7
|
|
Percent Change From Baseline in B Cell [Cluster Designation 20+ (CD20+)] Counts
Week 2
|
14.9 percent change
Standard Deviation 34.5
|
48.2 percent change
Standard Deviation 80.2
|
73.0 percent change
Standard Deviation 58.8
|
53.7 percent change
Standard Deviation 12.9
|
-12.0 percent change
Standard Deviation 41.4
|
|
Percent Change From Baseline in B Cell [Cluster Designation 20+ (CD20+)] Counts
Week 3
|
7.7 percent change
Standard Deviation 33.7
|
45.4 percent change
Standard Deviation 63.3
|
65.7 percent change
Standard Deviation 63.5
|
43.1 percent change
Standard Deviation 23.3
|
0.3 percent change
Standard Deviation 38.7
|
|
Percent Change From Baseline in B Cell [Cluster Designation 20+ (CD20+)] Counts
Week 4
|
-12.1 percent change
Standard Deviation 36.7
|
31.0 percent change
Standard Deviation 81.6
|
46.1 percent change
Standard Deviation 58.4
|
13.1 percent change
Standard Deviation 32.1
|
5.5 percent change
Standard Deviation 22.2
|
|
Percent Change From Baseline in B Cell [Cluster Designation 20+ (CD20+)] Counts
Week 6
|
6.7 percent change
Standard Deviation 42.8
|
10.9 percent change
Standard Deviation 65.9
|
67.7 percent change
Standard Deviation 69.4
|
48.9 percent change
Standard Deviation 43.2
|
2.1 percent change
Standard Deviation 44.6
|
|
Percent Change From Baseline in B Cell [Cluster Designation 20+ (CD20+)] Counts
Week 8
|
-10.3 percent change
Standard Deviation 37.3
|
2.2 percent change
Standard Deviation 57.0
|
36.7 percent change
Standard Deviation 58.6
|
5.9 percent change
Standard Deviation 46.0
|
2.9 percent change
Standard Deviation 32.2
|
|
Percent Change From Baseline in B Cell [Cluster Designation 20+ (CD20+)] Counts
Week 12
|
-17.6 percent change
Standard Deviation 31.7
|
-0.4 percent change
Standard Deviation 76.3
|
22.8 percent change
Standard Deviation 60.7
|
10.0 percent change
Standard Deviation 38.6
|
-7.0 percent change
Standard Deviation 24.7
|
|
Percent Change From Baseline in B Cell [Cluster Designation 20+ (CD20+)] Counts
Week 20
|
-30.4 percent change
Standard Deviation 32.8
|
-17.1 percent change
Standard Deviation 59.1
|
54.1 percent change
Standard Deviation 72.6
|
-13.4 percent change
Standard Deviation 30.7
|
2.5 percent change
Standard Deviation 65.1
|
|
Percent Change From Baseline in B Cell [Cluster Designation 20+ (CD20+)] Counts
Week 24
|
-34.4 percent change
Standard Deviation 32.3
|
-51.7 percent change
Standard Deviation 25.9
|
26.4 percent change
Standard Deviation 76.3
|
-30.4 percent change
Standard Deviation 26.3
|
-2.9 percent change
Standard Deviation 44.4
|
|
Percent Change From Baseline in B Cell [Cluster Designation 20+ (CD20+)] Counts
Week 32
|
-59.0 percent change
Standard Deviation 17.9
|
-50.7 percent change
Standard Deviation 36.1
|
-17.9 percent change
Standard Deviation 31.1
|
-38.7 percent change
Standard Deviation 17.8
|
-4.0 percent change
Standard Deviation 37.0
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Randomized participants who received at least 1 dose of study drug (tabalumab or placebo) and had a baseline and at least 1 post-baseline anti-CCP assessment using the Inova ELISA method. No participants were analyzed in the 120 mg tabalumab Q4W and Q2W cohorts.
During the analysis of anti-CCP, the analytical method was changed from the Inova ELISA method to the Roche Cobas 6000 method due to the discontinuation of a reagent used in the Inova ELISA method. The anti-CCP data are summarized separately for samples collected before and after the method change. No post-baseline samples from the 120 mg tabalumab Q4W and Q2W cohorts were analyzed using the Inova ELISA method. For both methods, a decrease in anti-CCP antibodies indicated an improvement in the participant's condition.
Outcome measures
| Measure |
30 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 30 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
60 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q4W
Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q2W
Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
Placebo
n=3 Participants
Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
|---|---|---|---|---|---|
|
Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody [Inova Enzyme-Linked Immunosorbent Assay (ELISA) Method]
|
-63.3 units (U)
Standard Deviation 138.8
|
63.3 units (U)
Standard Deviation 337.0
|
—
|
—
|
9.3 units (U)
Standard Deviation 58.2
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Randomized participants who received at least 1 dose of study drug (tabalumab or placebo) and had a baseline and at least 1 post-baseline anti-CCP assessment using the Roche Cobas 6000 method. No participants were analyzed in the 30 mg, 60 mg, and 120 mg tabalumab Q4W cohorts.
During the analysis of anti-CCP, the analytical method was changed from the Inova ELISA method to the Roche Cobas 6000 method due to the discontinuation of a reagent used in the Inova ELISA method. The anti-CCP data are summarized separately for samples collected before and after the method change. No baseline samples from the 30 mg, 60 mg, and 120 mg tabalumab Q4W cohorts were analyzed using the Roche Cobas 6000 method. For both methods, a decrease in anti-CCP antibodies indicated an improvement in the participant's condition.
Outcome measures
| Measure |
30 mg Tabalumab Q4W
Tabalumab: 30 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
60 mg Tabalumab Q4W
Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q4W
Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q2W
n=2 Participants
Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
Placebo
n=1 Participants
Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
|---|---|---|---|---|---|
|
Change From Baseline in Anti-CCP Antibody (Roche Cobas 6000 Method)
|
—
|
—
|
—
|
NA units per milliliter (U/mL)
Interval 0.0 to 35.5
Only 2 participants included in the analysis, therefore median is not calculable.
|
NA units per milliliter (U/mL)
Interval 0.0 to 0.0
Only 1 participant included in the analysis, therefore median is not calculable.
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Randomized participants who received at least 1 dose of study drug (tabalumab or placebo) and had a baseline and at least 1 post-baseline RF level assessment.
RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis (RA). Higher RF levels indicate an aggressive RA and a higher risk of joint damage. A decrease in RF levels indicate an improvement in the participant's condition.
Outcome measures
| Measure |
30 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 30 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
60 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q4W
n=5 Participants
Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q2W
n=5 Participants
Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
Placebo
n=7 Participants
Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
|---|---|---|---|---|---|
|
Change From Baseline in Rheumatoid Factor (RF)
|
-38.6 kilo units per liter (kU/L)
Standard Deviation 23.2
|
29.6 kilo units per liter (kU/L)
Standard Deviation 143.9
|
-108.0 kilo units per liter (kU/L)
Standard Deviation 97.0
|
-41.5 kilo units per liter (kU/L)
Standard Deviation 45.0
|
-12.9 kilo units per liter (kU/L)
Standard Deviation 76.2
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 16, 24, and 32Population: Randomized participants who received at least 1 dose of study drug (tabalumab or placebo) and had a baseline and at least 1 post-baseline serum immunoglobulin assessment.
Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA) levels are reported. A negative change indicates a decrease in immunoglobulin levels.
Outcome measures
| Measure |
30 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 30 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
60 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q2W
n=6 Participants
Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
Placebo
n=7 Participants
Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
|---|---|---|---|---|---|
|
Change From Baseline in Serum Immunoglobulins (IgG, IgM, IgA)
IgA, Week 24
|
-0.7 grams per liter (g/L)
Standard Deviation 0.2
|
-0.5 grams per liter (g/L)
Standard Deviation 0.3
|
-0.6 grams per liter (g/L)
Standard Deviation 0.4
|
-0.4 grams per liter (g/L)
Standard Deviation 0.3
|
-0.3 grams per liter (g/L)
Standard Deviation 0.4
|
|
Change From Baseline in Serum Immunoglobulins (IgG, IgM, IgA)
IgA, Week 32
|
-0.7 grams per liter (g/L)
Standard Deviation 0.4
|
-0.5 grams per liter (g/L)
Standard Deviation 0.4
|
-0.7 grams per liter (g/L)
Standard Deviation 0.4
|
-0.3 grams per liter (g/L)
Standard Deviation 0.2
|
-0.3 grams per liter (g/L)
Standard Deviation 0.4
|
|
Change From Baseline in Serum Immunoglobulins (IgG, IgM, IgA)
IgA, Week 16
|
-0.6 grams per liter (g/L)
Standard Deviation 0.3
|
-0.4 grams per liter (g/L)
Standard Deviation 0.2
|
-0.5 grams per liter (g/L)
Standard Deviation 0.2
|
-0.3 grams per liter (g/L)
Standard Deviation 0.4
|
-0.3 grams per liter (g/L)
Standard Deviation 0.3
|
|
Change From Baseline in Serum Immunoglobulins (IgG, IgM, IgA)
IgG, Week 4
|
-0.1 grams per liter (g/L)
Standard Deviation 1.6
|
0.0 grams per liter (g/L)
Standard Deviation 0.7
|
0.5 grams per liter (g/L)
Standard Deviation 2.5
|
-0.6 grams per liter (g/L)
Standard Deviation 1.0
|
-0.1 grams per liter (g/L)
Standard Deviation 1.0
|
|
Change From Baseline in Serum Immunoglobulins (IgG, IgM, IgA)
IgG, Week 16
|
-2.2 grams per liter (g/L)
Standard Deviation 1.0
|
-0.2 grams per liter (g/L)
Standard Deviation 2.6
|
-1.4 grams per liter (g/L)
Standard Deviation 1.0
|
-1.8 grams per liter (g/L)
Standard Deviation 1.4
|
-0.3 grams per liter (g/L)
Standard Deviation 1.5
|
|
Change From Baseline in Serum Immunoglobulins (IgG, IgM, IgA)
IgG, Week 24
|
-2.4 grams per liter (g/L)
Standard Deviation 1.1
|
-0.7 grams per liter (g/L)
Standard Deviation 2.8
|
-2.1 grams per liter (g/L)
Standard Deviation 2.5
|
-0.8 grams per liter (g/L)
Standard Deviation 0.8
|
-0.1 grams per liter (g/L)
Standard Deviation 1.9
|
|
Change From Baseline in Serum Immunoglobulins (IgG, IgM, IgA)
IgG, Week 32
|
-2.1 grams per liter (g/L)
Standard Deviation 1.3
|
-0.9 grams per liter (g/L)
Standard Deviation 2.4
|
-2.7 grams per liter (g/L)
Standard Deviation 2.1
|
-0.9 grams per liter (g/L)
Standard Deviation 1.2
|
0.4 grams per liter (g/L)
Standard Deviation 3.0
|
|
Change From Baseline in Serum Immunoglobulins (IgG, IgM, IgA)
IgM, Week 4
|
-0.2 grams per liter (g/L)
Standard Deviation 0.5
|
-0.1 grams per liter (g/L)
Standard Deviation 0.1
|
-0.2 grams per liter (g/L)
Standard Deviation 0.1
|
-0.1 grams per liter (g/L)
Standard Deviation 0.0
|
-0.1 grams per liter (g/L)
Standard Deviation 0.2
|
|
Change From Baseline in Serum Immunoglobulins (IgG, IgM, IgA)
IgM, Week 16
|
-0.4 grams per liter (g/L)
Standard Deviation 0.6
|
-0.3 grams per liter (g/L)
Standard Deviation 0.3
|
-0.2 grams per liter (g/L)
Standard Deviation 0.2
|
-0.2 grams per liter (g/L)
Standard Deviation 0.1
|
-0.1 grams per liter (g/L)
Standard Deviation 0.1
|
|
Change From Baseline in Serum Immunoglobulins (IgG, IgM, IgA)
IgM, Week 24
|
-0.6 grams per liter (g/L)
Standard Deviation 0.7
|
-0.3 grams per liter (g/L)
Standard Deviation 0.2
|
-0.3 grams per liter (g/L)
Standard Deviation 0.3
|
-0.2 grams per liter (g/L)
Standard Deviation 0.1
|
-0.1 grams per liter (g/L)
Standard Deviation 0.1
|
|
Change From Baseline in Serum Immunoglobulins (IgG, IgM, IgA)
IgM, Week 32
|
-0.6 grams per liter (g/L)
Standard Deviation 0.8
|
-0.3 grams per liter (g/L)
Standard Deviation 0.3
|
-0.4 grams per liter (g/L)
Standard Deviation 0.1
|
-0.2 grams per liter (g/L)
Standard Deviation 0.1
|
-0.1 grams per liter (g/L)
Standard Deviation 0.1
|
|
Change From Baseline in Serum Immunoglobulins (IgG, IgM, IgA)
IgA, Week 4
|
-0.1 grams per liter (g/L)
Standard Deviation 0.2
|
-0.2 grams per liter (g/L)
Standard Deviation 0.2
|
-0.4 grams per liter (g/L)
Standard Deviation 0.3
|
-0.1 grams per liter (g/L)
Standard Deviation 0.4
|
-0.3 grams per liter (g/L)
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 16, and 24Population: Randomized participants who received at least 1 dose of study drug (tabalumab or placebo) and had a baseline and at least 1 post-baseline CRP assessment.
CRP is an indicator of inflammation. The percent change from baseline in CRP=\[(post-baseline CRP- baseline CRP)/(baseline CRP)\]\*100. A negative change indicates an improvement in the participant's condition.
Outcome measures
| Measure |
30 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 30 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
60 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q2W
n=5 Participants
Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
Placebo
n=7 Participants
Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in CRP
Week 4
|
210.8 percent change
Standard Deviation 624.0
|
-16.0 percent change
Standard Deviation 53.1
|
-8.5 percent change
Standard Deviation 56.7
|
16.8 percent change
Standard Deviation 111.9
|
42.9 percent change
Standard Deviation 85.0
|
|
Percent Change From Baseline in CRP
Week 8
|
-54.0 percent change
Standard Deviation 16.6
|
18.1 percent change
Standard Deviation 126.4
|
167.0 percent change
Standard Deviation 537.9
|
31.6 percent change
Standard Deviation 85.9
|
-13.8 percent change
Standard Deviation 59.5
|
|
Percent Change From Baseline in CRP
Week 16
|
-38.1 percent change
Standard Deviation 76.3
|
840.8 percent change
Standard Deviation 2138.7
|
-83.1 percent change
Standard Deviation 15.0
|
-41.3 percent change
Standard Deviation 15.4
|
19.8 percent change
Standard Deviation 120.8
|
|
Percent Change From Baseline in CRP
Week 24
|
-55.9 percent change
Standard Deviation 43.9
|
-33.5 percent change
Standard Deviation 40.8
|
-75.5 percent change
Standard Deviation 36.4
|
119.9 percent change
Standard Deviation 147.7
|
39.6 percent change
Standard Deviation 89.3
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 16, and 24Population: Randomized participants who received at least 1 dose of study drug (tabalumab or placebo) and had a baseline and at least 1 post-baseline ESR assessment.
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Reference ranges are gender-specific and can vary slightly among laboratories. The normal range is approximately ≤10 millimeters per hour (mm/h) for males and ≤20 mm/h for females. Higher scores indicate greater inflammation. The percent change from baseline in ESR=\[(post-baseline ESR- baseline ESR)/(baseline ESR)\]\*100. A decrease in ESR indicates an improvement in the participant's condition.
Outcome measures
| Measure |
30 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 30 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
60 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q4W
n=6 Participants
Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q2W
n=6 Participants
Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
Placebo
n=7 Participants
Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Week 4
|
-5.9 percent change
Standard Deviation 31.8
|
-22.0 percent change
Standard Deviation 22.4
|
-7.5 percent change
Standard Deviation 32.4
|
11.7 percent change
Standard Deviation 28.4
|
6.1 percent change
Standard Deviation 30.8
|
|
Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Week 8
|
-27.5 percent change
Standard Deviation 22.1
|
-23.3 percent change
Standard Deviation 24.7
|
-3.1 percent change
Standard Deviation 55.9
|
8.9 percent change
Standard Deviation 33.3
|
13.3 percent change
Standard Deviation 49.4
|
|
Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Week 16
|
-26.1 percent change
Standard Deviation 38.2
|
-28.7 percent change
Standard Deviation 25.0
|
-47.4 percent change
Standard Deviation 27.4
|
-18.4 percent change
Standard Deviation 16.4
|
-3.0 percent change
Standard Deviation 41.6
|
|
Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Week 24
|
-40.7 percent change
Standard Deviation 20.4
|
-42.4 percent change
Standard Deviation 26.4
|
-56.4 percent change
Standard Deviation 28.1
|
22.3 percent change
Standard Deviation 64.2
|
26.3 percent change
Standard Deviation 56.7
|
Adverse Events
30 mg Tabalumab Q4W
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
60 mg Tabalumab Q4W
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
120 mg Tabalumab Q4W
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
120 mg Tabalumab Q2W
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
30 mg Tabalumab Q4W
n=6 participants at risk
Tabalumab: 30 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
60 mg Tabalumab Q4W
n=6 participants at risk
Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q4W
n=6 participants at risk
Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q2W
n=6 participants at risk
Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
Placebo
n=8 participants at risk
Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
|---|---|---|---|---|---|
|
Eye disorders
EYE MOVEMENT DISORDER
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Eye disorders
OCULAR HYPERTENSION
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Eye disorders
STRABISMUS
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Infections and infestations
PNEUMONIA LEGIONELLA
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
12.5%
1/8 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Injury, poisoning and procedural complications
CONJUNCTIVAL ABRASION
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
Other adverse events
| Measure |
30 mg Tabalumab Q4W
n=6 participants at risk
Tabalumab: 30 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
60 mg Tabalumab Q4W
n=6 participants at risk
Tabalumab: 60 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q4W
n=6 participants at risk
Tabalumab: 120 mg SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
|
120 mg Tabalumab Q2W
n=6 participants at risk
Tabalumab: 240 mg SC injection given as a loading dose at Week 0 followed by 120 mg SC injection Q2W for 20 weeks (Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
Placebo
n=8 participants at risk
Q4W cohorts: Placebo SC injection Q4W for 20 weeks (Weeks 0, 4, 8, 12, 16, and 20).
Q2W cohort: Placebo SC injection Q2W for 20 weeks (Weeks 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, and 20).
|
|---|---|---|---|---|---|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Endocrine disorders
GOITRE
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
12.5%
1/8 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Eye disorders
CHALAZION
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
50.0%
3/6 • Number of events 3 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Gastrointestinal disorders
PERIODONTITIS
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
12.5%
1/8 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
General disorders
INJECTION SITE ERYTHEMA
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
General disorders
PYREXIA
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
12.5%
1/8 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Infections and infestations
HERPES ZOSTER
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Infections and infestations
NASOPHARYNGITIS
|
33.3%
2/6 • Number of events 2 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
33.3%
2/6 • Number of events 2 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
33.3%
2/6 • Number of events 2 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
25.0%
2/8 • Number of events 3 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Infections and infestations
OSTEOMYELITIS
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Infections and infestations
PHARYNGITIS
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Infections and infestations
RHINITIS
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
12.5%
1/8 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Injury, poisoning and procedural complications
ANIMAL BITE
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
33.3%
2/6 • Number of events 2 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
33.3%
2/6 • Number of events 2 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Investigations
BLOOD URINE PRESENT
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Reproductive system and breast disorders
METRORRHAGIA
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/4 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/4 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
25.0%
1/4 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/7 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
25.0%
1/4 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
12.5%
1/8 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
12.5%
1/8 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
|
Vascular disorders
RHEUMATOID VASCULITIS
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/6 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
16.7%
1/6 • Number of events 1 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
0.00%
0/8 • Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60