Trial Outcomes & Findings for Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis (NCT NCT00235833)
NCT ID: NCT00235833
Last Updated: 2011-04-11
Results Overview
Number of subjects with American College of Rheumatology (ACR) criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender or swollen joint counts \[TJC or SJC, respectively\] and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: \[1\] physician's global assessment of disease activity \[PGA\], \[2\] subject's assessment of disease activity, \[3\] subject's assessment of pain, \[4\] subject's assessment of functional disability via a health assessment questionnaire \[HAQ\], and \[5\] C-reactive protein \[CRP\]) at each visit
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)
Results posted on
2011-04-11
Participant Flow
Japanese subjects with moderate to severe rheumatoid arthritis (RA) in relatively good physical health excluding RA symptoms and who completed a preceding continuous repeated administration study of adalimumab (DE035X/D2E7-J081-003) who wished to continue treatment until approval of adalimumab in Japan.
Participant milestones
| Measure |
Adalimumab 40 mg Eow
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Adalimumab 40 mg Eow
n=25 Participants
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
|
|---|---|
|
Age Continuous
|
54.1 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)Population: Analysis was based on observed data.
Number of subjects with American College of Rheumatology (ACR) criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender or swollen joint counts \[TJC or SJC, respectively\] and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: \[1\] physician's global assessment of disease activity \[PGA\], \[2\] subject's assessment of disease activity, \[3\] subject's assessment of pain, \[4\] subject's assessment of functional disability via a health assessment questionnaire \[HAQ\], and \[5\] C-reactive protein \[CRP\]) at each visit
Outcome measures
| Measure |
Adalimumab 40 mg Eow
n=25 Participants
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
|
|---|---|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 6 ACR20
|
15 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 6 ACR50
|
12 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 6 ACR70
|
5 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 12 ACR20
|
16 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 0 ACR20
|
12 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 0 ACR50
|
7 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 0 ACR70
|
5 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 12 ACR50
|
11 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 12 ACR70
|
6 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 18 ACR20
|
18 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 18 ACR50
|
11 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 18 ACR70
|
7 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 24 ACR20
|
16 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 24 ACR50
|
11 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 24 ACR70
|
4 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 36 ACR20
|
15 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 36 ACR50
|
10 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 36 ACR70
|
6 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 48 ACR20
|
13 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 48 ACR50
|
10 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 48 ACR70
|
5 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 60 ACR20
|
12 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 60 ACR50
|
11 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 60 ACR70
|
6 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 72 ACR20
|
11 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 72 ACR50
|
10 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 72 ACR70
|
3 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 84 ACR20
|
11 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 84 ACR50
|
9 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 84 ACR70
|
7 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 96 ACR20
|
11 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 96 ACR50
|
10 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 96 ACR70
|
6 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 108 ACR20
|
11 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 108 ACR50
|
10 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 108 ACR70
|
6 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 120 ACR20
|
10 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 120 ACR50
|
10 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 120 ACR70
|
6 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 132 ACR20
|
10 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 132 ACR50
|
7 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 132 ACR70
|
5 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 144 ACR20
|
10 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 144 ACR50
|
9 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 144 ACR70
|
7 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 156 ACR20
|
9 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 156 ACR50
|
8 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 156 ACR70
|
4 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 168 ACR20
|
9 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 168 ACR50
|
8 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 168 ACR70
|
6 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 180 ACR20
|
10 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 180 ACR50
|
9 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 180 ACR70
|
5 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 192 ACR20
|
9 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 192 ACR50
|
8 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 192 ACR70
|
5 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 204 ACR20
|
10 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 204 ACR50
|
8 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 204 ACR70
|
4 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 216 ACR20
|
9 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 216 ACR50
|
8 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 216 ACR70
|
4 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 228 ACR20
|
9 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 228 ACR50
|
7 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 228 ACR70
|
3 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 240 ACR20
|
7 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 240 ACR50
|
4 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 240 ACR70
|
1 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 252 ACR20
|
5 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 252 ACR50
|
3 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 252 ACR70
|
2 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 264 ACR20
|
2 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 264 ACR50
|
1 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Week 264 ACR70
|
1 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Final Value ACR20
|
13 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Final Value ACR50
|
11 participants
|
|
Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)
Final Value ACR70
|
8 participants
|
SECONDARY outcome
Timeframe: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in tender joint count (TJC, max = 68), a component of the ACR criteria, by visit
Outcome measures
| Measure |
Adalimumab 40 mg Eow
n=25 Participants
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
|
|---|---|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 0
|
-11.2 TJC
Standard Deviation 14.5
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 6
|
-13.4 TJC
Standard Deviation 11.2
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 12
|
-16.0 TJC
Standard Deviation 14.0
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 18
|
-17.5 TJC
Standard Deviation 12.2
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 24
|
-16.3 TJC
Standard Deviation 13.7
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 36
|
-17.0 TJC
Standard Deviation 13.4
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 48
|
-18.1 TJC
Standard Deviation 13.8
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 60
|
-18.5 TJC
Standard Deviation 13.2
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 72
|
-18.1 TJC
Standard Deviation 13.2
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 84
|
-21.9 TJC
Standard Deviation 13.7
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 96
|
-22.8 TJC
Standard Deviation 13.6
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 108
|
-21.8 TJC
Standard Deviation 13.6
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 120
|
-22.7 TJC
Standard Deviation 14.4
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 132
|
-22.0 TJC
Standard Deviation 14.5
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 144
|
-21.2 TJC
Standard Deviation 14.4
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 156
|
-22.1 TJC
Standard Deviation 14.9
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 168
|
-22.7 TJC
Standard Deviation 13.6
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 180
|
-22.7 TJC
Standard Deviation 13.5
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 192
|
-23.3 TJC
Standard Deviation 14.5
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 204
|
-23.1 TJC
Standard Deviation 14.7
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 216
|
-23.7 TJC
Standard Deviation 14.7
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 228
|
-23.4 TJC
Standard Deviation 14.7
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 240
|
-24.6 TJC
Standard Deviation 13.7
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 252
|
-26.7 TJC
Standard Deviation 17.5
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Week 264
|
-25.0 TJC
Standard Deviation 7.1
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit
Final Value
|
-15.8 TJC
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)Mean change from baseline(last assessment in preceding study prior to adalimumab injection) in the SJC (max = 66) component of the ACR criteria
Outcome measures
| Measure |
Adalimumab 40 mg Eow
n=25 Participants
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
|
|---|---|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 144
|
-14.0 SJC
Standard Deviation 3.9
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 0
|
-8.8 SJC
Standard Deviation 11.0
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 6
|
-11.3 SJC
Standard Deviation 11.3
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 12
|
-12.0 SJC
Standard Deviation 12.1
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 18
|
-14.4 SJC
Standard Deviation 9.6
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 24
|
-13.8 SJC
Standard Deviation 10.7
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 36
|
-12.4 SJC
Standard Deviation 6.8
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 48
|
-14.9 SJC
Standard Deviation 6.3
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 60
|
-14.8 SJC
Standard Deviation 5.7
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 72
|
-14.5 SJC
Standard Deviation 6.5
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 84
|
-13.5 SJC
Standard Deviation 4.7
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 96
|
-13.9 SJC
Standard Deviation 5.8
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 108
|
-13.8 SJC
Standard Deviation 5.7
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 120
|
-13.2 SJC
Standard Deviation 4.5
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 132
|
-13.2 SJC
Standard Deviation 4.2
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 156
|
-13.3 SJC
Standard Deviation 4.3
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 168
|
-13.2 SJC
Standard Deviation 5.5
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 180
|
-13.7 SJC
Standard Deviation 4.4
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 192
|
-13.4 SJC
Standard Deviation 4.9
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 204
|
-12.9 SJC
Standard Deviation 5.3
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 216
|
-12.6 SJC
Standard Deviation 5.8
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 228
|
-12.9 SJC
Standard Deviation 5.5
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 240
|
-11.8 SJC
Standard Deviation 5.8
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 252
|
-11.8 SJC
Standard Deviation 5.8
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Week 264
|
-12.0 SJC
Standard Deviation 8.5
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit
Final Value
|
-10.1 SJC
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst possible assessment), a component of the ACR criteria, by visit.
Outcome measures
| Measure |
Adalimumab 40 mg Eow
n=25 Participants
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
|
|---|---|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 0
|
-27.0 mm on scale
Standard Deviation 28.6
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 6
|
-34.5 mm on scale
Standard Deviation 28.4
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 12
|
-40.7 mm on scale
Standard Deviation 22.0
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 18
|
-42.2 mm on scale
Standard Deviation 22.1
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 24
|
-41.3 mm on scale
Standard Deviation 24.2
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 36
|
-34.3 mm on scale
Standard Deviation 19.9
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 48
|
-40.7 mm on scale
Standard Deviation 21.7
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 60
|
-39.2 mm on scale
Standard Deviation 27.8
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 72
|
-39.2 mm on scale
Standard Deviation 26.7
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 84
|
-40.1 mm on scale
Standard Deviation 29.8
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 96
|
-51.7 mm on scale
Standard Deviation 20.9
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 108
|
-50.6 mm on scale
Standard Deviation 20.6
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 120
|
-50.5 mm on scale
Standard Deviation 27.3
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 132
|
-50.1 mm on scale
Standard Deviation 21.1
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 144
|
-43.6 mm on scale
Standard Deviation 28.1
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 156
|
-47.2 mm on scale
Standard Deviation 28.9
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 168
|
-49.5 mm on scale
Standard Deviation 25.6
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 180
|
-51.8 mm on scale
Standard Deviation 24.4
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 192
|
-49.6 mm on scale
Standard Deviation 26.7
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 204
|
-47.5 mm on scale
Standard Deviation 22.7
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 216
|
-52.5 mm on scale
Standard Deviation 22.8
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 228
|
-49.5 mm on scale
Standard Deviation 23.2
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 240
|
-47.3 mm on scale
Standard Deviation 18.9
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 252
|
-51.7 mm on scale
Standard Deviation 23.5
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 264
|
-35.5 mm on scale
Standard Deviation 38.9
|
|
Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Final Value
|
-31.2 mm on scale
Standard Deviation 32.7
|
SECONDARY outcome
Timeframe: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in subject's global assessment of disease activity (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit
Outcome measures
| Measure |
Adalimumab 40 mg Eow
n=25 Participants
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
|
|---|---|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 0
|
-21.7 mm on scale
Standard Deviation 27.4
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 6
|
-29.5 mm on scale
Standard Deviation 25.8
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 12
|
-33.3 mm on scale
Standard Deviation 25.8
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 18
|
-35.1 mm on scale
Standard Deviation 25.7
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 24
|
-35.6 mm on scale
Standard Deviation 22.2
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 36
|
-33.0 mm on scale
Standard Deviation 24.5
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 48
|
-38.3 mm on scale
Standard Deviation 24.3
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 60
|
-38.7 mm on scale
Standard Deviation 26.4
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 72
|
-39.3 mm on scale
Standard Deviation 24.9
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 84
|
-37.1 mm on scale
Standard Deviation 30.3
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 96
|
-42.9 mm on scale
Standard Deviation 26.0
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 108
|
-35.1 mm on scale
Standard Deviation 31.0
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 120
|
-40.4 mm on scale
Standard Deviation 26.2
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 132
|
-34.1 mm on scale
Standard Deviation 21.3
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 144
|
-37.3 mm on scale
Standard Deviation 26.4
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 156
|
-34.5 mm on scale
Standard Deviation 31.1
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 168
|
-37.2 mm on scale
Standard Deviation 26.3
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 180
|
-36.1 mm on scale
Standard Deviation 20.4
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 192
|
-35.3 mm on scale
Standard Deviation 26.1
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 204
|
-35.0 mm on scale
Standard Deviation 18.0
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 216
|
-30.3 mm on scale
Standard Deviation 23.9
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 228
|
-30.7 mm on scale
Standard Deviation 27.6
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 240
|
-23.9 mm on scale
Standard Deviation 22.4
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 252
|
-25.0 mm on scale
Standard Deviation 21.2
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Week 264
|
-19.5 mm on scale
Standard Deviation 10.6
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit
Final Value
|
-20.0 mm on scale
Standard Deviation 27.9
|
SECONDARY outcome
Timeframe: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in subject's assessment of pain (using a visual analog scale from 0 - 100 mm with 100 mm being the worst possible pain), a component of the ACR criteria, by visit
Outcome measures
| Measure |
Adalimumab 40 mg Eow
n=25 Participants
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
|
|---|---|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 0
|
-13.7 mm on scale
Standard Deviation 31.6
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 6
|
-23.1 mm on scale
Standard Deviation 24.7
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 12
|
-27.2 mm on scale
Standard Deviation 27.3
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 18
|
-29.1 mm on scale
Standard Deviation 28.2
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 24
|
-30.6 mm on scale
Standard Deviation 20.2
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 36
|
-26.2 mm on scale
Standard Deviation 28.2
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 48
|
-32.7 mm on scale
Standard Deviation 22.2
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 60
|
-33.4 mm on scale
Standard Deviation 26.1
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 72
|
-33.4 mm on scale
Standard Deviation 24.2
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 84
|
-32.9 mm on scale
Standard Deviation 26.7
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 96
|
-37.6 mm on scale
Standard Deviation 22.7
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 108
|
-31.8 mm on scale
Standard Deviation 27.6
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 120
|
-35.0 mm on scale
Standard Deviation 21.9
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 132
|
-30.0 mm on scale
Standard Deviation 18.6
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 144
|
-33.1 mm on scale
Standard Deviation 24.1
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 156
|
-29.9 mm on scale
Standard Deviation 31.0
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 168
|
-31.8 mm on scale
Standard Deviation 24.0
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 180
|
-32.8 mm on scale
Standard Deviation 19.8
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 192
|
-31.0 mm on scale
Standard Deviation 23.4
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 204
|
-30.6 mm on scale
Standard Deviation 17.4
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 216
|
-24.4 mm on scale
Standard Deviation 23.7
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 228
|
-26.5 mm on scale
Standard Deviation 26.8
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 240
|
-24.9 mm on scale
Standard Deviation 23.7
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 252
|
-20.3 mm on scale
Standard Deviation 24.4
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Week 264
|
-7.0 mm on scale
Standard Deviation 2.8
|
|
Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit
Final Value
|
-14.4 mm on scale
Standard Deviation 29.6
|
SECONDARY outcome
Timeframe: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in disability index of the health assessment questionnaire \[HAQ; includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a scale from 0 - 3 to measure the ability to perform certain activities (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so).\], a component the of ACR criteria, by visit
Outcome measures
| Measure |
Adalimumab 40 mg Eow
n=25 Participants
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
|
|---|---|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 96
|
-0.80 units on a scale
Standard Deviation 0.71
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 252
|
-0.25 units on a scale
Standard Deviation 0.80
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 0
|
-0.41 units on a scale
Standard Deviation 0.77
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 6
|
-0.48 units on a scale
Standard Deviation 0.64
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 12
|
-0.47 units on a scale
Standard Deviation 0.65
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 18
|
-0.50 units on a scale
Standard Deviation 0.72
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 24
|
-0.49 units on a scale
Standard Deviation 0.76
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 36
|
-0.43 units on a scale
Standard Deviation 0.77
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 48
|
-0.63 units on a scale
Standard Deviation 0.72
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 60
|
-0.66 units on a scale
Standard Deviation 0.81
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 72
|
-0.73 units on a scale
Standard Deviation 0.81
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 84
|
-0.82 units on a scale
Standard Deviation 0.71
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 108
|
-0.74 units on a scale
Standard Deviation 0.83
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 120
|
-0.73 units on a scale
Standard Deviation 0.81
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 132
|
-0.63 units on a scale
Standard Deviation 0.80
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 144
|
-0.63 units on a scale
Standard Deviation 0.80
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 156
|
-0.58 units on a scale
Standard Deviation 0.69
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 168
|
-0.64 units on a scale
Standard Deviation 0.78
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 180
|
-0.63 units on a scale
Standard Deviation 0.70
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 192
|
-0.49 units on a scale
Standard Deviation 0.73
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 204
|
-0.51 units on a scale
Standard Deviation 0.67
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 216
|
-0.51 units on a scale
Standard Deviation 0.77
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 228
|
-0.49 units on a scale
Standard Deviation 0.93
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 240
|
-0.36 units on a scale
Standard Deviation 0.70
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Week 264
|
0.25 units on a scale
Standard Deviation 1.41
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire [HAQ], a Component the of ACR Criteria, by Visit
Final Value
|
-0.31 units on a scale
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)Mean change from baseline (last assessment in preceding study prior to adalimumab injection) in C-reactive protein \[CRP; mg/dL\], a component of the ACR criteria, by visit.
Outcome measures
| Measure |
Adalimumab 40 mg Eow
n=25 Participants
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
|
|---|---|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 0
|
-0.92 mg/dL
Standard Deviation 2.64
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 6
|
-2.30 mg/dL
Standard Deviation 2.73
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 12
|
-2.49 mg/dL
Standard Deviation 3.55
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 18
|
-2.11 mg/dL
Standard Deviation 3.22
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 24
|
-2.62 mg/dL
Standard Deviation 2.49
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 36
|
-2.42 mg/dL
Standard Deviation 3.17
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 48
|
-2.94 mg/dL
Standard Deviation 3.37
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 60
|
-3.31 mg/dL
Standard Deviation 3.15
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 72
|
-3.05 mg/dL
Standard Deviation 3.35
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 84
|
-2.84 mg/dL
Standard Deviation 3.50
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 96
|
-3.37 mg/dL
Standard Deviation 3.08
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 108
|
-3.07 mg/dL
Standard Deviation 3.09
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 120
|
-3.16 mg/dL
Standard Deviation 3.62
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 132
|
-3.23 mg/dL
Standard Deviation 3.39
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 144
|
-3.14 mg/dL
Standard Deviation 3.66
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 156
|
0.01 mg/dL
Standard Deviation 10.96
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 168
|
-3.47 mg/dL
Standard Deviation 3.42
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 180
|
-3.49 mg/dL
Standard Deviation 3.28
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 192
|
-3.21 mg/dL
Standard Deviation 3.42
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 204
|
-3.30 mg/dL
Standard Deviation 3.22
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 216
|
-2.90 mg/dL
Standard Deviation 2.57
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 228
|
-2.93 mg/dL
Standard Deviation 2.57
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 240
|
-1.71 mg/dL
Standard Deviation 6.10
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 252
|
-1.89 mg/dL
Standard Deviation 3.56
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Week 264
|
-4.16 mg/dL
Standard Deviation 5.35
|
|
Mean Change From Baseline in C-reactive Protein [CRP; mg/dL], a Component of the ACR Criteria, by Visit.
Final Value
|
-1.14 mg/dL
Standard Deviation 4.23
|
SECONDARY outcome
Timeframe: Every 6 weeks up to Week 24 and every 12 weeks thereafterSum of the duration (from start of study to each study visit) when a subject with American College of Rheumatology (ACR) criteria improved by 20% (ACR20) in tender or swollen joint counts \[TJC or SJC, respectively\] and 20% improvement in 3 of the following 5 criteria: \[1\] Physician's global assessment (PGA), \[2\] subject's assessment of disease activity, \[3\] subject's assessment of pain, \[4\] subject's assessment of functional disability via a health assessment questionnaire \[HAQ\], and \[5\] C-reactive protein (CRP)
Outcome measures
| Measure |
Adalimumab 40 mg Eow
n=25 Participants
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
|
|---|---|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 6
|
3.2 Weeks
Standard Deviation 2.7
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 12
|
7.0 Weeks
Standard Deviation 5.5
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 18
|
11.0 Weeks
Standard Deviation 8.0
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 24
|
15.1 Weeks
Standard Deviation 10.6
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 36
|
22.6 Weeks
Standard Deviation 15.9
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 48
|
29.3 Weeks
Standard Deviation 21.1
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 60
|
35.3 Weeks
Standard Deviation 26.3
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 72
|
40.8 Weeks
Standard Deviation 31.3
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 84
|
46.1 Weeks
Standard Deviation 36.2
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 96
|
51.4 Weeks
Standard Deviation 41.3
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 108
|
56.6 Weeks
Standard Deviation 46.7
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 120
|
61.7 Weeks
Standard Deviation 52.0
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 132
|
66.5 Weeks
Standard Deviation 57.2
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 144
|
71.3 Weeks
Standard Deviation 62.5
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 156
|
75.8 Weeks
Standard Deviation 67.7
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 168
|
80.2 Weeks
Standard Deviation 72.7
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 180
|
84.7 Weeks
Standard Deviation 78.0
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 192
|
89.3 Weeks
Standard Deviation 83.4
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 204
|
93.8 Weeks
Standard Deviation 88.2
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 216
|
98.4 Weeks
Standard Deviation 92.7
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 228
|
102.7 Weeks
Standard Deviation 97.1
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 240
|
106.6 Weeks
Standard Deviation 101.0
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 252
|
109.4 Weeks
Standard Deviation 104.2
|
|
Area Under the Curve (AUC; From Start of the Study to Each Study Visit) of Subjects' Who Improved at Least 20% in ACR Response Criteria (ACR20 Response)
Week 0 - Week 264
|
111.1 Weeks
Standard Deviation 106.4
|
SECONDARY outcome
Timeframe: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)Population: Subjects analyzed (as-observed) include only those who had morning stiffness at baseline.
The number of subjects with morning stiffness (assessed as present or absent) at each visit among those who had morning stiffness at baseline (21).
Outcome measures
| Measure |
Adalimumab 40 mg Eow
n=21 Participants
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
|
|---|---|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 0
|
16 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 6
|
15 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 12
|
11 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 18
|
11 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 24
|
9 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 36
|
10 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 48
|
6 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 60
|
5 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 72
|
7 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 84
|
6 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 96
|
4 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 108
|
4 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 120
|
3 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 132
|
3 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 144
|
3 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 156
|
3 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 168
|
2 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 180
|
2 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 192
|
3 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 204
|
4 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 216
|
3 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 228
|
3 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 240
|
3 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 252
|
2 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Week 264
|
1 participants
|
|
Number of Subjects With Morning Stiffness at Each Visit
Final Value
|
15 participants
|
Adverse Events
Adalimumab 40 mg Eow
Serious events: 10 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adalimumab 40 mg Eow
n=25 participants at risk
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
4.0%
1/25
|
|
Cardiac disorders
Brugada syndrome
|
4.0%
1/25
|
|
General disorders
Pyrexia
|
4.0%
1/25
|
|
Infections and infestations
Pyelonephritis
|
4.0%
1/25
|
|
Infections and infestations
Sepsis
|
4.0%
1/25
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
4.0%
1/25
|
|
Investigations
C-reactive protein increased
|
4.0%
1/25
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
1/25
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
12.0%
3/25
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
4.0%
1/25
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's Lymphoma
|
4.0%
1/25
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
4.0%
1/25
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
4.0%
1/25
|
|
Renal and urinary disorders
Calculus ureteric
|
4.0%
1/25
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
4.0%
1/25
|
Other adverse events
| Measure |
Adalimumab 40 mg Eow
n=25 participants at risk
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
24.0%
6/25
|
|
Gastrointestinal disorders
Dental caries
|
12.0%
3/25
|
|
Gastrointestinal disorders
Gastritis
|
12.0%
3/25
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
3/25
|
|
Gastrointestinal disorders
Enterocolitis
|
8.0%
2/25
|
|
Gastrointestinal disorders
Nausea
|
8.0%
2/25
|
|
Gastrointestinal disorders
Periodontitis
|
8.0%
2/25
|
|
General disorders
Adverse drug reaction
|
16.0%
4/25
|
|
General disorders
Chest pain
|
8.0%
2/25
|
|
General disorders
Injection site reaction
|
8.0%
2/25
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
16.0%
4/25
|
|
Infections and infestations
Nasopharyngitis
|
60.0%
15/25
|
|
Infections and infestations
Cystitis
|
16.0%
4/25
|
|
Infections and infestations
Gastroenteritis
|
12.0%
3/25
|
|
Infections and infestations
Bronchitis
|
8.0%
2/25
|
|
Infections and infestations
Herpes zoster
|
8.0%
2/25
|
|
Infections and infestations
Pharyngitis
|
8.0%
2/25
|
|
Infections and infestations
Rhinitis
|
8.0%
2/25
|
|
Infections and infestations
Sinusitis
|
8.0%
2/25
|
|
Infections and infestations
Tinea blanca
|
8.0%
2/25
|
|
Infections and infestations
Tinea pedis
|
8.0%
2/25
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
2/25
|
|
Injury, poisoning and procedural complications
Contusion
|
16.0%
4/25
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
12.0%
3/25
|
|
Injury, poisoning and procedural complications
Animal bite
|
8.0%
2/25
|
|
Injury, poisoning and procedural complications
Fall
|
8.0%
2/25
|
|
Injury, poisoning and procedural complications
Wound
|
8.0%
2/25
|
|
Investigations
Blood glucose increased
|
12.0%
3/25
|
|
Investigations
DNA antibody positive
|
12.0%
3/25
|
|
Investigations
Blood alkaline phosphatase increased
|
8.0%
2/25
|
|
Investigations
Blood triglycerides increased
|
8.0%
2/25
|
|
Investigations
Lymphocyte percentage decreased
|
8.0%
2/25
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
8.0%
2/25
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.0%
4/25
|
|
Nervous system disorders
Dizziness
|
12.0%
3/25
|
|
Psychiatric disorders
Insomnia
|
16.0%
4/25
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.0%
4/25
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.0%
3/25
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
12.0%
3/25
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.0%
2/25
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal discomfort
|
8.0%
2/25
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
8.0%
2/25
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.0%
2/25
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
5/25
|
|
Skin and subcutaneous tissue disorders
Eczema
|
16.0%
4/25
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.0%
4/25
|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.0%
3/25
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
12.0%
3/25
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
12.0%
3/25
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
12.0%
3/25
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
8.0%
2/25
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
8.0%
2/25
|
|
Vascular disorders
Hypertension
|
8.0%
2/25
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Additional Information
Medical Information Specialist
Abbott
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee Disclosure agreements vary; most restrictive agreement states Medical Institution shall not disclose materials/information disclosed by Abbott Japan in connection with the Clinical Research, or information obtained by conducting the Clinical Research, to third parties without Abbott Japan's prior written approval. When Medical Institution intends to publish information obtained by conducting the Clinical Research, Medical Institution shall obtain Abbott Japan's prior written approval.
- Publication restrictions are in place
Restriction type: OTHER