Trial Outcomes & Findings for Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate (NCT NCT01373151)
NCT ID: NCT01373151
Last Updated: 2021-12-06
Results Overview
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
418 participants
Primary outcome timeframe
At 12 Weeks
Results posted on
2021-12-06
Participant Flow
Participant milestones
| Measure |
Placebo+MTX
BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(25)+MTX
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)+MTX
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)+MTX
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
ADA+MTX
Adalimumab(ADA) + Methotrexate
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
61
|
59
|
60
|
60
|
59
|
60
|
59
|
|
Period 1
COMPLETED
|
56
|
59
|
56
|
59
|
54
|
56
|
59
|
|
Period 1
NOT COMPLETED
|
5
|
0
|
4
|
1
|
5
|
4
|
0
|
|
Period 2
STARTED
|
56
|
58
|
56
|
59
|
54
|
55
|
59
|
|
Period 2
COMPLETED
|
47
|
57
|
52
|
54
|
52
|
55
|
54
|
|
Period 2
NOT COMPLETED
|
9
|
1
|
4
|
5
|
2
|
0
|
5
|
Reasons for withdrawal
| Measure |
Placebo+MTX
BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(25)+MTX
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)+MTX
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)+MTX
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
ADA+MTX
Adalimumab(ADA) + Methotrexate
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Period 1
Lack of Efficacy
|
3
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Period 1
Adverse Event
|
0
|
0
|
1
|
0
|
4
|
3
|
0
|
|
Period 1
Withdrawal by Subject
|
2
|
0
|
3
|
1
|
0
|
1
|
0
|
|
Period 2
Lack of Efficacy
|
9
|
0
|
0
|
1
|
2
|
0
|
3
|
|
Period 2
Adverse Event
|
0
|
0
|
3
|
3
|
0
|
0
|
1
|
|
Period 2
subject request to discontinue
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Period 2
Other
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate
Baseline characteristics by cohort
| Measure |
Placebo+MTX
n=61 Participants
BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(25)+MTX
n=59 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)+MTX
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)
n=59 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)+MTX
n=60 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
ADA+MTX
n=59 Participants
Adalimumab(ADA) + Methotrexate
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
Total
n=418 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
55 Participants
n=8 Participants
|
51 Participants
n=8 Participants
|
366 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
52 Participants
n=24 Participants
|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 11.03 • n=5 Participants
|
47.4 years
STANDARD_DEVIATION 10.97 • n=7 Participants
|
55.0 years
STANDARD_DEVIATION 12.21 • n=5 Participants
|
49.9 years
STANDARD_DEVIATION 13.95 • n=4 Participants
|
50.0 years
STANDARD_DEVIATION 12.53 • n=21 Participants
|
46.4 years
STANDARD_DEVIATION 11.91 • n=8 Participants
|
52.8 years
STANDARD_DEVIATION 11.41 • n=8 Participants
|
50.4 years
STANDARD_DEVIATION 12.26 • n=24 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
49 Participants
n=8 Participants
|
48 Participants
n=8 Participants
|
343 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
75 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: At 12 WeeksPopulation: All randomized and treated participants
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Outcome measures
| Measure |
Placebo+MTX
n=61 Participants
BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(25)+MTX
n=59 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)+MTX
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)
n=59 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)+MTX
n=60 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
ADA+MTX
n=59 Participants
Adalimumab(ADA) + Methotrexate
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants Achieving an American College of Rheumatology (ACR) 20% Response Rate
|
39.3 percentage of participants
|
76.3 percentage of participants
|
55.0 percentage of participants
|
73.3 percentage of participants
|
61.0 percentage of participants
|
60.0 percentage of participants
|
76.3 percentage of participants
|
SECONDARY outcome
Timeframe: At 24 weeksPopulation: All randomized and treated participants
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Outcome measures
| Measure |
Placebo+MTX
n=61 Participants
BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(25)+MTX
n=59 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)+MTX
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)
n=59 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)+MTX
n=60 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
ADA+MTX
n=59 Participants
Adalimumab(ADA) + Methotrexate
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants With ACR 20 Response
|
37.7 percentage of participants
|
81.4 percentage of participants
|
58.3 percentage of participants
|
65.0 percentage of participants
|
57.6 percentage of participants
|
66.7 percentage of participants
|
66.1 percentage of participants
|
SECONDARY outcome
Timeframe: At weeks 12 and 24Population: All randomized and treated participants
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Outcome measures
| Measure |
Placebo+MTX
n=61 Participants
BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(25)+MTX
n=59 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)+MTX
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)
n=59 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)+MTX
n=60 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
ADA+MTX
n=59 Participants
Adalimumab(ADA) + Methotrexate
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants Achieving ACR 50 Response Rate
12 weeks
|
21.3 percentage of participants
|
49.2 percentage of participants
|
26.7 percentage of participants
|
43.3 percentage of participants
|
28.8 percentage of participants
|
26.7 percentage of participants
|
30.5 percentage of participants
|
|
Percent of Participants Achieving ACR 50 Response Rate
24 weeks
|
16.4 percentage of participants
|
47.5 percentage of participants
|
36.7 percentage of participants
|
46.7 percentage of participants
|
33.9 percentage of participants
|
43.3 percentage of participants
|
47.5 percentage of participants
|
SECONDARY outcome
Timeframe: At weeks 12 and 24Population: All randomized and treated participants
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Outcome measures
| Measure |
Placebo+MTX
n=61 Participants
BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(25)+MTX
n=59 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)+MTX
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)
n=59 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)+MTX
n=60 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
ADA+MTX
n=59 Participants
Adalimumab(ADA) + Methotrexate
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants Achieving ACR 70 Response Rate
12 weeks
|
8.2 percentage of participants
|
18.6 percentage of participants
|
13.3 percentage of participants
|
26.7 percentage of participants
|
11.9 percentage of participants
|
13.3 percentage of participants
|
11.9 percentage of participants
|
|
Percent of Participants Achieving ACR 70 Response Rate
24 weeks
|
6.6 percentage of participants
|
27.1 percentage of participants
|
16.7 percentage of participants
|
40.0 percentage of participants
|
25.4 percentage of participants
|
30.0 percentage of participants
|
18.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, weeks 12 and 24Population: All randomized and treated participants (participants with missing values at each timepoint were not included)
DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission.
Outcome measures
| Measure |
Placebo+MTX
n=61 Participants
BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(25)+MTX
n=59 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)+MTX
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)
n=59 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)+MTX
n=60 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
ADA+MTX
n=59 Participants
Adalimumab(ADA) + Methotrexate
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Disease Activity as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
12 weeks
|
-1.15 score on a scale
Standard Error 0.1652
|
-2.65 score on a scale
Standard Error 0.1610
|
-2.29 score on a scale
Standard Error 0.1603
|
-2.68 score on a scale
Standard Error 0.1597
|
-2.34 score on a scale
Standard Error 0.1665
|
-2.52 score on a scale
Standard Error 0.1610
|
-2.04 score on a scale
Standard Error 0.1647
|
|
Mean Change From Baseline in Disease Activity as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
24 weeks
|
-1.69 score on a scale
Standard Error 0.1825
|
-3.01 score on a scale
Standard Error 0.1684
|
-2.60 score on a scale
Standard Error 0.1719
|
-3.06 score on a scale
Standard Error 0.1713
|
-2.55 score on a scale
Standard Error 0.1769
|
-2.95 score on a scale
Standard Error 0.1706
|
-2.52 score on a scale
Standard Error 0.1769
|
SECONDARY outcome
Timeframe: At weeks 12 and 24Population: All randomized and treated participants
DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission.
Outcome measures
| Measure |
Placebo+MTX
n=61 Participants
BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(25)+MTX
n=59 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)+MTX
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)
n=59 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)+MTX
n=60 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
ADA+MTX
n=59 Participants
Adalimumab(ADA) + Methotrexate
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants With Remission by DAS28-CRP
week 12
|
1.6 percentage of participants
|
35.6 percentage of participants
|
21.7 percentage of participants
|
35.0 percentage of participants
|
25.4 percentage of participants
|
26.7 percentage of participants
|
20.3 percentage of participants
|
|
Percent of Participants With Remission by DAS28-CRP
week 24
|
11.5 percentage of participants
|
49.2 percentage of participants
|
25.0 percentage of participants
|
40.0 percentage of participants
|
35.6 percentage of participants
|
41.7 percentage of participants
|
23.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, weeks 12 and 24Population: All randomized and treated participants (participants with missing values at each timepoint were not included)
CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76. CDAI \<= 2.8 = Remission CDAI \> 2.8 and \<= 10 = Low Disease Activity CDAI \> 10 and \<= 22 = Moderate Disease Activity CDAI \> 22 = High Disease Activity
Outcome measures
| Measure |
Placebo+MTX
n=61 Participants
BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(25)+MTX
n=59 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)+MTX
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)
n=59 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)+MTX
n=60 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
ADA+MTX
n=59 Participants
Adalimumab(ADA) + Methotrexate
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Clinical Disease Activity Index (CDAI)
week 24
|
-20.3 score on a scale
Standard Error 1.703
|
-26.1 score on a scale
Standard Error 1.587
|
-22.0 score on a scale
Standard Error 1.613
|
-26.9 score on a scale
Standard Error 1.622
|
-21.7 score on a scale
Standard Error 1.643
|
-25.6 score on a scale
Standard Error 1.606
|
-26.2 score on a scale
Standard Error 1.631
|
|
Mean Change From Baseline in Clinical Disease Activity Index (CDAI)
week 12
|
-14.5 score on a scale
Standard Error 1.727
|
-22.7 score on a scale
Standard Error 1.686
|
-17.7 score on a scale
Standard Error 1.687
|
-23.1 score on a scale
Standard Error 1.701
|
-19.8 score on a scale
Standard Error 1.738
|
-21.0 score on a scale
Standard Error 1.697
|
-22.4 score on a scale
Standard Error 1.702
|
SECONDARY outcome
Timeframe: At weeks 12 and 24Population: All randomized and treated subjects
CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76. CDAI \<= 2.8 = Remission CDAI \> 2.8 and \<= 10 = Low Disease Activity CDAI \> 10 and \<= 22 = Moderate Disease Activity CDAI \> 22 = High Disease Activity
Outcome measures
| Measure |
Placebo+MTX
n=61 Participants
BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(25)+MTX
n=59 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)+MTX
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)
n=59 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)+MTX
n=60 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
ADA+MTX
n=59 Participants
Adalimumab(ADA) + Methotrexate
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants With Remission by CDAI
week 12
|
3.3 percentage of participants
|
11.9 percentage of participants
|
8.3 percentage of participants
|
8.3 percentage of participants
|
3.4 percentage of participants
|
3.3 percentage of participants
|
8.5 percentage of participants
|
|
Percent of Participants With Remission by CDAI
week 24
|
1.6 percentage of participants
|
15.3 percentage of participants
|
6.7 percentage of participants
|
21.7 percentage of participants
|
6.8 percentage of participants
|
20.0 percentage of participants
|
8.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, weeks 12 and 24Population: All randomized and treated subjects (participants with missing values at each timepoint were not included)
SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86. 0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity
Outcome measures
| Measure |
Placebo+MTX
n=61 Participants
BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(25)+MTX
n=59 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)+MTX
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)
n=59 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)+MTX
n=60 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
ADA+MTX
n=59 Participants
Adalimumab(ADA) + Methotrexate
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Simplified Disease Activity Index (SDAI)
week 12
|
-14.5 score on a scale
Standard Error 1.794
|
-24.9 score on a scale
Standard Error 1.749
|
-20.4 score on a scale
Standard Error 1.745
|
-25.3 score on a scale
Standard Error 1.734
|
-22.2 score on a scale
Standard Error 1.811
|
-23.3 score on a scale
Standard Error 1.747
|
-23.2 score on a scale
Standard Error 1.785
|
|
Mean Change From Baseline in Simplified Disease Activity Index (SDAI)
week 24
|
-20.6 score on a scale
Standard Error 1.812
|
-28.4 score on a scale
Standard Error 1.670
|
-24.5 score on a scale
Standard Error 1.704
|
-29.1 score on a scale
Standard Error 1.698
|
-23.5 score on a scale
Standard Error 1.755
|
-27.6 score on a scale
Standard Error 1.691
|
-27.6 score on a scale
Standard Error 1.752
|
SECONDARY outcome
Timeframe: At weeks 12 and 24Population: All randomized and treated subjects
SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86. 0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity
Outcome measures
| Measure |
Placebo+MTX
n=61 Participants
BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(25)+MTX
n=59 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)+MTX
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)
n=59 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)+MTX
n=60 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
ADA+MTX
n=59 Participants
Adalimumab(ADA) + Methotrexate
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants With Remission by SDAI
week 12
|
1.6 percentage of participants
|
11.9 percentage of participants
|
8.3 percentage of participants
|
8.3 percentage of participants
|
6.8 percentage of participants
|
5.0 percentage of participants
|
10.2 percentage of participants
|
|
Percent of Participants With Remission by SDAI
week 24
|
4.9 percentage of participants
|
18.6 percentage of participants
|
6.7 percentage of participants
|
20. percentage of participants
|
6.8 percentage of participants
|
23.3 percentage of participants
|
8.5 percentage of participants
|
SECONDARY outcome
Timeframe: At weeks 12 and 24Population: All randomized and treated subjects
Boolean-based definition: At any time point, a patient must satisfy all of the following: TJC ≤1 (0-28) SJC ≤1 (0-28) CRP ≤1 mg/dl Patient Global Assessment ≤1 (on a 0-10 scale)
Outcome measures
| Measure |
Placebo+MTX
n=61 Participants
BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(25)+MTX
n=59 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)+MTX
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)
n=59 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)+MTX
n=60 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
ADA+MTX
n=59 Participants
Adalimumab(ADA) + Methotrexate
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants With Remission Rate by Boolean Definition
week 12
|
3.3 percentage of participants
|
8.5 percentage of participants
|
6.7 percentage of participants
|
10. percentage of participants
|
1.7 percentage of participants
|
5.0 percentage of participants
|
5.1 percentage of participants
|
|
Percent of Participants With Remission Rate by Boolean Definition
week 24
|
1.6 percentage of participants
|
10.2 percentage of participants
|
5.0 percentage of participants
|
13.3 percentage of participants
|
5.1 percentage of participants
|
18.3 percentage of participants
|
10.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, weeks 12 and 24Population: All randomized and treated subjects (participants with missing values at each timepoint were not included)
Patients report the amount of difficulty they have in performing 8 categories. Each category is scored on a scale ranging from 0 (performed without any difficulty) to 3 (cannot be done at all). The HAQ-DI is then calculated by summing the scores and dividing by the number of categories answered. Total score is between 0-3.0. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment. The HAQ-DI cannot be calculated if the subject does not have scores for at least 6 categories. A response was defined as a subject with a reduction from baseline in HAQ-DI of at least 0.22.
Outcome measures
| Measure |
Placebo+MTX
n=61 Participants
BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(25)+MTX
n=59 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)+MTX
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)
n=59 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)+MTX
n=60 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
ADA+MTX
n=59 Participants
Adalimumab(ADA) + Methotrexate
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index
week 12
|
-0.44 score on a scale
Standard Error 0.0827
|
-0.66 score on a scale
Standard Error 0.0801
|
-0.47 score on a scale
Standard Error 0.0807
|
-0.70 score on a scale
Standard Error 0.0811
|
-0.51 score on a scale
Standard Error 0.0834
|
-0.60 score on a scale
Standard Error 0.0807
|
-0.60 score on a scale
Standard Error 0.0819
|
|
Mean Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index
week 24
|
-0.62 score on a scale
Standard Error 0.0861
|
-0.68 score on a scale
Standard Error 0.0806
|
-0.64 score on a scale
Standard Error 0.0823
|
-0.79 score on a scale
Standard Error 0.0823
|
-0.60 score on a scale
Standard Error 0.0840
|
-0.71 score on a scale
Standard Error 0.0811
|
-0.66 score on a scale
Standard Error 0.0833
|
SECONDARY outcome
Timeframe: Baseline, weeks 12 and 24Population: All randomized and treated subjects (participants with missing values at each timepoint were not included)
The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status.
Outcome measures
| Measure |
Placebo+MTX
n=61 Participants
BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(25)+MTX
n=59 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)+MTX
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)
n=59 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)+MTX
n=60 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
ADA+MTX
n=59 Participants
Adalimumab(ADA) + Methotrexate
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Short Form 36 (SF-36) as Measured by Physical and Mental Components
Mental component (week 12)
|
5.3 score on a scale
Standard Error 1.274
|
5.9 score on a scale
Standard Error 1.240
|
4.5 score on a scale
Standard Error 1.251
|
7.3 score on a scale
Standard Error 1.244
|
4.0 score on a scale
Standard Error 1.283
|
5.7 score on a scale
Standard Error 1.230
|
6.4 score on a scale
Standard Error 1.250
|
|
Mean Change From Baseline in Short Form 36 (SF-36) as Measured by Physical and Mental Components
Mental component (week 24)
|
6.0 score on a scale
Standard Error 1.327
|
6.4 score on a scale
Standard Error 1.208
|
6.6 score on a scale
Standard Error 1.247
|
7.5 score on a scale
Standard Error 1.247
|
5.3 score on a scale
Standard Error 1.271
|
8.0 score on a scale
Standard Error 1.219
|
7.1 score on a scale
Standard Error 1.246
|
|
Mean Change From Baseline in Short Form 36 (SF-36) as Measured by Physical and Mental Components
Physical component (week 12)
|
4.0 score on a scale
Standard Error 1.030
|
7.5 score on a scale
Standard Error 0.999
|
7.3 score on a scale
Standard Error 1.010
|
9.5 score on a scale
Standard Error 1.002
|
6.8 score on a scale
Standard Error 1.028
|
7.3 score on a scale
Standard Error 0.994
|
8.4 score on a scale
Standard Error 1.006
|
|
Mean Change From Baseline in Short Form 36 (SF-36) as Measured by Physical and Mental Components
Physical component (week 24)
|
6.2 score on a scale
Standard Error 1.149
|
8.6 score on a scale
Standard Error 1.045
|
9.4 score on a scale
Standard Error 1.080
|
10.9 score on a scale
Standard Error 1.076
|
7.7 score on a scale
Standard Error 1.094
|
8.2 score on a scale
Standard Error 1.057
|
8.2 score on a scale
Standard Error 1.077
|
SECONDARY outcome
Timeframe: Baseline, weeks 12 and 24Population: All randomized and treated subjects (participants with missing values at each timepoint were not included)
A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity.
Outcome measures
| Measure |
Placebo+MTX
n=61 Participants
BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(25)+MTX
n=59 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)+MTX
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)
n=59 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)+MTX
n=60 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
ADA+MTX
n=59 Participants
Adalimumab(ADA) + Methotrexate
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Fatigue Severity (VAS) Score
week 12
|
-14.3 score on a scale
Standard Error 3.146
|
-20.8 score on a scale
Standard Error 3.060
|
-19.4 score on a scale
Standard Error 3.077
|
-27.4 score on a scale
Standard Error 3.077
|
-21.7 score on a scale
Standard Error 3.180
|
-18.6 score on a scale
Standard Error 3.056
|
-26.3 score on a scale
Standard Error 3.080
|
|
Mean Change From Baseline in Fatigue Severity (VAS) Score
week 24
|
-12.9 score on a scale
Standard Error 3.306
|
-23.9 score on a scale
Standard Error 3.052
|
-22.3 score on a scale
Standard Error 3.131
|
-31.3 score on a scale
Standard Error 3.103
|
-17.7 score on a scale
Standard Error 3.184
|
-23.4 score on a scale
Standard Error 3.056
|
-27.0 score on a scale
Standard Error 3.134
|
SECONDARY outcome
Timeframe: Baseline, weeks 12 and 24Population: All randomized and treated subjects (participants with missing values at each timepoint were not included)
The WPAI yeilds four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivty loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment WPAI outcomes are expressed as impairment percentages with each subscale score ranging from 0-100. The subscale scores are added and averaged to produce a total WPAI score between 0-100. Higher scores indicate greater impairment and less productivity.
Outcome measures
| Measure |
Placebo+MTX
n=61 Participants
BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(25)+MTX
n=59 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)+MTX
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)
n=59 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)+MTX
n=60 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
ADA+MTX
n=59 Participants
Adalimumab(ADA) + Methotrexate
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Scores
week 12
|
-9.6 score on a scale
Standard Error 3.273
|
-2.2 score on a scale
Standard Error 3.443
|
-8.7 score on a scale
Standard Error 3.673
|
-12.0 score on a scale
Standard Error 3.081
|
-13.7 score on a scale
Standard Error 3.285
|
-10.0 score on a scale
Standard Error 3.575
|
-11.7 score on a scale
Standard Error 6.281
|
|
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Scores
week 24
|
-10.7 score on a scale
Standard Error 4.033
|
-1.8 score on a scale
Standard Error 3.893
|
-17.1 score on a scale
Standard Error 4.200
|
-12.1 score on a scale
Standard Error 3.448
|
-5.9 score on a scale
Standard Error 3.788
|
-12.6 score on a scale
Standard Error 3.938
|
-4.7 score on a scale
Standard Error 6.379
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: All randomized and treated subjects (participants with missing values at each timepoint were not included)
Outcome measures
| Measure |
Placebo+MTX
n=61 Participants
BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(25)+MTX
n=59 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)+MTX
n=60 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)
n=59 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)+MTX
n=60 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
ADA+MTX
n=59 Participants
Adalimumab(ADA) + Methotrexate
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Radiographic (MRI) Progression of Synovitis, Osteitis (Bone Marrow Edema), Bone Erosion and Cartilage Loss (Joint-space Narrowing)
Erosion
|
1.3 cubic millimeters
Standard Error 0.352
|
0.4 cubic millimeters
Standard Error 0.341
|
1.1 cubic millimeters
Standard Error 0.356
|
0.3 cubic millimeters
Standard Error 0.334
|
1.0 cubic millimeters
Standard Error 0.369
|
-0.2 cubic millimeters
Standard Error 0.341
|
-0.5 cubic millimeters
Standard Error 0.348
|
|
Mean Change From Baseline in Radiographic (MRI) Progression of Synovitis, Osteitis (Bone Marrow Edema), Bone Erosion and Cartilage Loss (Joint-space Narrowing)
Edema
|
0.2 cubic millimeters
Standard Error 1.009
|
-6.4 cubic millimeters
Standard Error 0.993
|
-2.6 cubic millimeters
Standard Error 1.015
|
-4.7 cubic millimeters
Standard Error 0.998
|
-4.6 cubic millimeters
Standard Error 1.036
|
-5.1 cubic millimeters
Standard Error 0.993
|
-3.1 cubic millimeters
Standard Error 1.008
|
|
Mean Change From Baseline in Radiographic (MRI) Progression of Synovitis, Osteitis (Bone Marrow Edema), Bone Erosion and Cartilage Loss (Joint-space Narrowing)
Synovitis
|
-0.5 cubic millimeters
Standard Error 0.436
|
-2.5 cubic millimeters
Standard Error 0.427
|
-1.4 cubic millimeters
Standard Error 0.440
|
-2.2 cubic millimeters
Standard Error 0.426
|
-2.9 cubic millimeters
Standard Error 0.447
|
-2.5 cubic millimeters
Standard Error 0.427
|
-2.9 cubic millimeters
Standard Error 0.435
|
|
Mean Change From Baseline in Radiographic (MRI) Progression of Synovitis, Osteitis (Bone Marrow Edema), Bone Erosion and Cartilage Loss (Joint-space Narrowing)
Narrowing
|
0.1 cubic millimeters
Standard Error 0.133
|
-0.1 cubic millimeters
Standard Error 0.130
|
0.2 cubic millimeters
Standard Error 0.135
|
-0.1 cubic millimeters
Standard Error 0.126
|
0.1 cubic millimeters
Standard Error 0.139
|
0.0 cubic millimeters
Standard Error 0.129
|
-0.2 cubic millimeters
Standard Error 0.132
|
SECONDARY outcome
Timeframe: Baseline and week 24Population: All randomized and treated subjects (participants with missing values at each timepoint were not included)
The Sharp-van der Heijde total score ranges from 0-528. Scores for erosion range from 0 to 5 in the hands and 0 to 10 in the feet and reflect erosion size, with 0 defined as no erosion and 3 defined as a large erosion passing the midline of the joint. If there is \> 1 erosion per joint, scores can be combined to give a maximum score of 5 per joint in the hands and 10 per joint in the feet (a maximum of 5 at each side of the joint). Joint space narrowing scores vary from 0 to 4 in both the hands and feet, with 0 being normal and 4 being the absence of joint space with evident ankylosis or subluxation. Gross osteolysis and pencil-in-cup change are scored separately and, if present, are assigned the maximum score for erosion and joint space narrowing for the same affected joint. Higher scores indicate increased joint damage.
Outcome measures
| Measure |
Placebo+MTX
n=44 Participants
BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(25)+MTX
n=59 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)
n=54 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)+MTX
n=54 Participants
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)
n=53 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)+MTX
n=53 Participants
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
ADA+MTX
n=54 Participants
Adalimumab(ADA) + Methotrexate
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Radiographic (X-ray) Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijde Total Score
|
1.8 score on a scale
Standard Error 0.353
|
0.3 score on a scale
Standard Error 0.320
|
0.0 score on a scale
Standard Error 0.327
|
0.1 score on a scale
Standard Error 0.324
|
0.1 score on a scale
Standard Error 0.330
|
0.1 score on a scale
Standard Error 0.336
|
0.1 score on a scale
Standard Error 0.333
|
Adverse Events
Placebo+MTX
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Clazakizumab(25)+MTX
Serious events: 5 serious events
Other events: 43 other events
Deaths: 0 deaths
Clazakizumab(100)
Serious events: 5 serious events
Other events: 43 other events
Deaths: 0 deaths
Clazakizumab(100)+MTX
Serious events: 5 serious events
Other events: 51 other events
Deaths: 0 deaths
Clazakizumab(200)
Serious events: 8 serious events
Other events: 43 other events
Deaths: 0 deaths
Clazakizumab(200)+MTX
Serious events: 5 serious events
Other events: 50 other events
Deaths: 0 deaths
ADA+MTX
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo+MTX
n=61 participants at risk
BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(25)+MTX
n=59 participants at risk
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)
n=60 participants at risk
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)+MTX
n=60 participants at risk
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)
n=59 participants at risk
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)+MTX
n=60 participants at risk
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
ADA+MTX
n=59 participants at risk
Adalimumab(ADA) + Methotrexate
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
3.3%
2/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Infections and infestations
Cellulitis
|
0.00%
0/61 • Up to 48 weeks per participant
|
3.4%
2/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Infections and infestations
Pneumonia
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
|
Infections and infestations
Infective tenosynovitis
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Infections and infestations
Influenza
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Infections and infestations
Sepsis
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/61 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
5.1%
3/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/61 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Injury, poisoning and procedural complications
Medication error
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Infections and infestations
Traumatic haematoma
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/61 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Psychiatric disorders
Depression
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Vascular disorders
Hypertension
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Eye disorders
Cataract
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Nervous system disorders
Headache
|
1.6%
1/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
Other adverse events
| Measure |
Placebo+MTX
n=61 participants at risk
BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(25)+MTX
n=59 participants at risk
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)
n=60 participants at risk
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(100)+MTX
n=60 participants at risk
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)
n=59 participants at risk
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
Clazakizumab(200)+MTX
n=60 participants at risk
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
ADA+MTX
n=59 participants at risk
Adalimumab(ADA) + Methotrexate
Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks
Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
1.6%
1/61 • Up to 48 weeks per participant
|
11.9%
7/59 • Up to 48 weeks per participant
|
6.7%
4/60 • Up to 48 weeks per participant
|
3.3%
2/60 • Up to 48 weeks per participant
|
3.4%
2/59 • Up to 48 weeks per participant
|
6.7%
4/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
|
Infections and infestations
Urinary tract infection
|
6.6%
4/61 • Up to 48 weeks per participant
|
8.5%
5/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
3.3%
2/60 • Up to 48 weeks per participant
|
3.4%
2/59 • Up to 48 weeks per participant
|
8.3%
5/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
|
Infections and infestations
Bronchitis
|
0.00%
0/61 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
3.3%
2/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
3.4%
2/59 • Up to 48 weeks per participant
|
3.3%
2/60 • Up to 48 weeks per participant
|
5.1%
3/59 • Up to 48 weeks per participant
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/61 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
5.1%
3/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
5.1%
3/59 • Up to 48 weeks per participant
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.3%
2/61 • Up to 48 weeks per participant
|
11.9%
7/59 • Up to 48 weeks per participant
|
11.7%
7/60 • Up to 48 weeks per participant
|
8.3%
5/60 • Up to 48 weeks per participant
|
8.5%
5/59 • Up to 48 weeks per participant
|
15.0%
9/60 • Up to 48 weeks per participant
|
3.4%
2/59 • Up to 48 weeks per participant
|
|
General disorders
Injection site reaction
|
0.00%
0/61 • Up to 48 weeks per participant
|
13.6%
8/59 • Up to 48 weeks per participant
|
15.0%
9/60 • Up to 48 weeks per participant
|
18.3%
11/60 • Up to 48 weeks per participant
|
23.7%
14/59 • Up to 48 weeks per participant
|
15.0%
9/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
|
General disorders
Ejection site erythema
|
0.00%
0/61 • Up to 48 weeks per participant
|
3.4%
2/59 • Up to 48 weeks per participant
|
13.3%
8/60 • Up to 48 weeks per participant
|
25.0%
15/60 • Up to 48 weeks per participant
|
16.9%
10/59 • Up to 48 weeks per participant
|
15.0%
9/60 • Up to 48 weeks per participant
|
3.4%
2/59 • Up to 48 weeks per participant
|
|
General disorders
Injection site rash
|
0.00%
0/61 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
13.3%
8/60 • Up to 48 weeks per participant
|
13.3%
8/60 • Up to 48 weeks per participant
|
3.4%
2/59 • Up to 48 weeks per participant
|
13.3%
8/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
General disorders
Injection site dermatitis
|
0.00%
0/61 • Up to 48 weeks per participant
|
6.8%
4/59 • Up to 48 weeks per participant
|
5.0%
3/60 • Up to 48 weeks per participant
|
6.7%
4/60 • Up to 48 weeks per participant
|
6.8%
4/59 • Up to 48 weeks per participant
|
11.7%
7/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
General disorders
Asthenia
|
3.3%
2/61 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
5.0%
3/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
|
General disorders
Injection site hypersensitivity
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
5.0%
3/60 • Up to 48 weeks per participant
|
3.3%
2/60 • Up to 48 weeks per participant
|
3.4%
2/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
General disorders
Injection site papule
|
0.00%
0/61 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
3.3%
2/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
5.0%
3/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
General disorders
Injection site pruritis
|
0.00%
0/61 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
6.7%
4/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
General disorders
Injection site macule
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
5.0%
3/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
General disorders
Injection site pain
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
5.1%
3/59 • Up to 48 weeks per participant
|
|
Infections and infestations
Nasopharyngitis
|
6.6%
4/61 • Up to 48 weeks per participant
|
3.4%
2/59 • Up to 48 weeks per participant
|
5.0%
3/60 • Up to 48 weeks per participant
|
6.7%
4/60 • Up to 48 weeks per participant
|
5.1%
3/59 • Up to 48 weeks per participant
|
11.7%
7/60 • Up to 48 weeks per participant
|
3.4%
2/59 • Up to 48 weeks per participant
|
|
Infections and infestations
Upper respiraory tract infection
|
11.5%
7/61 • Up to 48 weeks per participant
|
8.5%
5/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
5.0%
3/60 • Up to 48 weeks per participant
|
11.9%
7/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Infections and infestations
Pharyngitis
|
8.2%
5/61 • Up to 48 weeks per participant
|
3.4%
2/59 • Up to 48 weeks per participant
|
5.0%
3/60 • Up to 48 weeks per participant
|
5.0%
3/60 • Up to 48 weeks per participant
|
5.1%
3/59 • Up to 48 weeks per participant
|
5.0%
3/60 • Up to 48 weeks per participant
|
5.1%
3/59 • Up to 48 weeks per participant
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
3.3%
2/61 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
3.3%
2/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
5.1%
3/59 • Up to 48 weeks per participant
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/61 • Up to 48 weeks per participant
|
5.1%
3/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
3.4%
2/59 • Up to 48 weeks per participant
|
|
Investigations
Alanine aminotransferase increased
|
3.3%
2/61 • Up to 48 weeks per participant
|
18.6%
11/59 • Up to 48 weeks per participant
|
3.3%
2/60 • Up to 48 weeks per participant
|
21.7%
13/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
30.0%
18/60 • Up to 48 weeks per participant
|
5.1%
3/59 • Up to 48 weeks per participant
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/61 • Up to 48 weeks per participant
|
13.6%
8/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
23.3%
14/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
20.0%
12/60 • Up to 48 weeks per participant
|
3.4%
2/59 • Up to 48 weeks per participant
|
|
Investigations
Gamma-glutamyltransferease increased
|
1.6%
1/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
3.3%
2/60 • Up to 48 weeks per participant
|
6.7%
4/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
3.3%
2/60 • Up to 48 weeks per participant
|
3.4%
2/59 • Up to 48 weeks per participant
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/61 • Up to 48 weeks per participant
|
5.1%
3/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
5.0%
3/60 • Up to 48 weeks per participant
|
3.4%
2/59 • Up to 48 weeks per participant
|
5.0%
3/60 • Up to 48 weeks per participant
|
10.2%
6/59 • Up to 48 weeks per participant
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/61 • Up to 48 weeks per participant
|
5.1%
3/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
3.3%
2/60 • Up to 48 weeks per participant
|
5.1%
3/59 • Up to 48 weeks per participant
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/61 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
5.1%
3/59 • Up to 48 weeks per participant
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/61 • Up to 48 weeks per participant
|
3.4%
2/59 • Up to 48 weeks per participant
|
6.7%
4/60 • Up to 48 weeks per participant
|
3.3%
2/60 • Up to 48 weeks per participant
|
6.8%
4/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
3.4%
2/59 • Up to 48 weeks per participant
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.6%
1/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
5.0%
3/60 • Up to 48 weeks per participant
|
3.3%
2/60 • Up to 48 weeks per participant
|
6.8%
4/59 • Up to 48 weeks per participant
|
5.0%
3/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Vascular disorders
Hypertension
|
1.6%
1/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
6.7%
4/60 • Up to 48 weeks per participant
|
10.2%
6/59 • Up to 48 weeks per participant
|
3.3%
2/60 • Up to 48 weeks per participant
|
3.4%
2/59 • Up to 48 weeks per participant
|
|
Nervous system disorders
Headache
|
8.2%
5/61 • Up to 48 weeks per participant
|
3.4%
2/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
3.3%
2/60 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
5.0%
3/60 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/61 • Up to 48 weeks per participant
|
1.7%
1/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
5.1%
3/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
1.7%
1/60 • Up to 48 weeks per participant
|
6.8%
4/59 • Up to 48 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
5.0%
3/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/61 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
5.0%
3/60 • Up to 48 weeks per participant
|
0.00%
0/59 • Up to 48 weeks per participant
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place