Trial Outcomes & Findings for Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis (NCT NCT00603993)
NCT ID: NCT00603993
Last Updated: 2011-06-21
Results Overview
Number of responders with 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 physical disability via a health assessment questionnaire disability index(HAQ-DI), and \[5\] C-reactive protein (CRP) at each visit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
88 participants
Primary outcome timeframe
Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)
Results posted on
2011-06-21
Participant Flow
Participant milestones
| Measure |
Adalimumab 40 mg or 80 mg Every Other Week (Eow)
Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 \[NCT00235872\]) subcutaneously (sc) eow until approval of adalimumab in Japan
|
|---|---|
|
Overall Study
STARTED
|
88
|
|
Overall Study
COMPLETED
|
68
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Adalimumab 40 mg or 80 mg Every Other Week (Eow)
n=88 Participants
Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 \[NCT00235872\]) subcutaneously (sc) eow until approval of adalimumab in Japan
|
|---|---|
|
Age Continuous
|
52.3 years
STANDARD_DEVIATION 11.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
|
Region of Enrollment
Japan
|
88 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)Population: Analysis was based on observed data.
Number of responders with 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 physical disability via a health assessment questionnaire disability index(HAQ-DI), and \[5\] C-reactive protein (CRP) at each visit.
Outcome measures
| Measure |
Adalimumab 40 mg or 80 mg Every Other Week (Eow)
n=88 Participants
Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 \[NCT00235872\]) subcutaneously (sc) eow until approval of adalimumab in Japan
|
|---|---|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 120 ACR20
|
28 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 132 ACR20
|
7 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 132 ACR50
|
3 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 132 ACR70
|
3 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 0 ACR20
|
66 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 0 ACR50
|
48 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 0 ACR70
|
28 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 4 ACR20
|
64 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 4 ACR50
|
44 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 4 ACR70
|
27 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 8 ACR20
|
69 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 8 ACR50
|
45 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 8 ACR70
|
32 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 12 ACR20
|
68 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 12 ACR50
|
50 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 12 ACR70
|
30 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 16 ACR20
|
67 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 16 ACR50
|
49 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 16 ACR70
|
30 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 20 ACR20
|
68 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 20 ACR50
|
49 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 20 ACR70
|
31 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 24 ACR20
|
63 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 24 ACR50
|
48 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 24 ACR70
|
29 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 36 ACR20
|
64 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 36 ACR50
|
45 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 36 ACR70
|
32 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 48 ACR20
|
62 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 48 ACR50
|
46 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 48 ACR70
|
27 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 60 ACR20
|
56 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Final Value ACR20
|
62 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 60 ACR50
|
44 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 60 ACR70
|
28 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 72 ACR20
|
57 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 72 ACR50
|
47 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 72 ACR70
|
32 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 84 ACR20
|
57 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 84 ACR50
|
42 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 84 ACR70
|
29 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 96 ACR20
|
56 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 96 ACR50
|
43 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 96 ACR70
|
27 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 108 ACR20
|
54 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 108 ACR50
|
45 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 108 ACR70
|
29 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 120 ACR50
|
24 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 120 ACR70
|
16 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Final Value ACR50
|
49 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Final Value ACR70
|
35 participants
|
SECONDARY outcome
Timeframe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in TJC (max = 68), a component of the ACR criteria, by visit
Outcome measures
| Measure |
Adalimumab 40 mg or 80 mg Every Other Week (Eow)
n=88 Participants
Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 \[NCT00235872\]) subcutaneously (sc) 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
Baseline
|
20.5 TJC
Standard Deviation 12.1
|
|
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
Week 0
|
-15.3 TJC
Standard Deviation 11.3
|
|
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
Week 4
|
-14.9 TJC
Standard Deviation 11.4
|
|
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
Week 8
|
-15.3 TJC
Standard Deviation 11.1
|
|
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
Week 12
|
-14.8 TJC
Standard Deviation 10.7
|
|
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
Week 16
|
-14.7 TJC
Standard Deviation 10.8
|
|
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
Week 20
|
-15.2 TJC
Standard Deviation 10.6
|
|
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
Week 24
|
-15.5 TJC
Standard Deviation 10.9
|
|
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
Week 36
|
-14.9 TJC
Standard Deviation 10.9
|
|
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
Week 48
|
-15.0 TJC
Standard Deviation 11.5
|
|
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
Week 60
|
-15.4 TJC
Standard Deviation 11.4
|
|
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
Week 72
|
-15.7 TJC
Standard Deviation 11.5
|
|
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
Week 84
|
-16.1 TJC
Standard Deviation 11.3
|
|
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
Week 96
|
-16.8 TJC
Standard Deviation 11.8
|
|
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
Week 108
|
-16.5 TJC
Standard Deviation 11.6
|
|
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
Week 120
|
-18.1 TJC
Standard Deviation 12.4
|
|
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
Week 132
|
-19.4 TJC
Standard Deviation 9.5
|
|
Mean Change From Baseline in Tender Joint Count (TJC; Max = 68), a Component of the ACR Criteria, by Visit
Final
|
-14.9 TJC
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in SJC (max = 66), a component of the ACR criteria, by visit
Outcome measures
| Measure |
Adalimumab 40 mg or 80 mg Every Other Week (Eow)
n=88 Participants
Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 \[NCT00235872\]) subcutaneously (sc) 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
Baseline
|
15.8 SJC
Standard Deviation 8.6
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
Week 0
|
-11.9 SJC
Standard Deviation 8.3
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
Week 4
|
-11.9 SJC
Standard Deviation 8.3
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
Week 8
|
-12.3 SJC
Standard Deviation 8.0
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
Week 12
|
-11.9 SJC
Standard Deviation 7.7
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
Week 16
|
-12.1 SJC
Standard Deviation 7.8
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
Week 20
|
-11.9 SJC
Standard Deviation 8.3
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
Week 24
|
-11.9 SJC
Standard Deviation 8.3
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
Week 36
|
-11.6 SJC
Standard Deviation 8.3
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
Week 48
|
-11.5 SJC
Standard Deviation 8.8
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
Week 60
|
-11.5 SJC
Standard Deviation 8.4
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
Week 72
|
-12.2 SJC
Standard Deviation 7.8
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
Week 84
|
-12.3 SJC
Standard Deviation 7.8
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
Week 96
|
-12.0 SJC
Standard Deviation 7.8
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
Week 108
|
-12.0 SJC
Standard Deviation 8.2
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
Week 120
|
-12.5 SJC
Standard Deviation 8.7
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
Week 132
|
-12.9 SJC
Standard Deviation 8.0
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria by Visit
Final
|
-11.6 SJC
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: Every 4 weeks weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in PGA (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 or 80 mg Every Other Week (Eow)
n=88 Participants
Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 \[NCT00235872\]) subcutaneously (sc) 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 Assessment), a Component of the ACR Criteria, by Visit
Baseline
|
63.2 mm on a scale
Standard Deviation 21.8
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 0
|
-41.0 mm on a scale
Standard Deviation 26.2
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 4
|
-39.5 mm on a scale
Standard Deviation 27.0
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 8
|
-43.3 mm on a 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 Assessment), a Component of the ACR Criteria, by Visit
Week 12
|
-41.6 mm on a scale
Standard Deviation 24.9
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 16
|
-42.1 mm on a scale
Standard Deviation 25.5
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 20
|
-44.0 mm on a scale
Standard Deviation 24.6
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 24
|
-42.3 mm on a scale
Standard Deviation 26.2
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 36
|
-42.2 mm on a scale
Standard Deviation 25.8
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 48
|
-41.4 mm on a scale
Standard Deviation 27.9
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 60
|
-40.7 mm on a scale
Standard Deviation 28.3
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 72
|
-42.2 mm on a scale
Standard Deviation 26.5
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 84
|
-41.9 mm on a scale
Standard Deviation 26.2
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 96
|
-44.6 mm on a scale
Standard Deviation 24.1
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 108
|
-44.7 mm on a scale
Standard Deviation 25.9
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 120
|
-48.8 mm on a scale
Standard Deviation 27.4
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 132
|
-62.4 mm on a scale
Standard Deviation 10.7
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Final
|
-38.8 mm on a scale
Standard Deviation 31.9
|
SECONDARY outcome
Timeframe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final value)mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in subjects 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 or 80 mg Every Other Week (Eow)
n=88 Participants
Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 \[NCT00235872\]) subcutaneously (sc) 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 Assessment), a Component of the ACR Criteria, by Visit
Baseline
|
58.4 mm on a scale
Standard Deviation 26.8
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 0
|
-34.0 mm on a scale
Standard Deviation 29.8
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 4
|
-32.2 mm on a 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 Assessment), a Component of the ACR Criteria, by Visit
Week 8
|
-33.4 mm on a scale
Standard Deviation 29.2
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 12
|
-33.9 mm on a scale
Standard Deviation 29.3
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 16
|
-33.2 mm on a scale
Standard Deviation 30.9
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 20
|
-34.9 mm on a scale
Standard Deviation 30.4
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 24
|
-33.1 mm on a scale
Standard Deviation 30.9
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 36
|
-31.6 mm on a scale
Standard Deviation 34.6
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 48
|
-33.3 mm on a scale
Standard Deviation 34.0
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 60
|
-30.7 mm on a scale
Standard Deviation 33.6
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 72
|
-33.9 mm on a scale
Standard Deviation 33.1
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 84
|
-31.1 mm on a scale
Standard Deviation 32.2
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 96
|
-31.7 mm on a scale
Standard Deviation 30.4
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 108
|
-33.0 mm on a scale
Standard Deviation 34.0
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 120
|
-37.9 mm on a scale
Standard Deviation 29.4
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Week 132
|
-37.0 mm on a scale
Standard Deviation 31.7
|
|
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 Assessment), a Component of the ACR Criteria, by Visit
Final
|
-29.5 mm on a scale
Standard Deviation 35.7
|
SECONDARY outcome
Timeframe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in subject's assessment of pain (on a visual analog scale from 0 - 100 mm with 100 mm being the worst pain), a component of the ACR criteria, by visit
Outcome measures
| Measure |
Adalimumab 40 mg or 80 mg Every Other Week (Eow)
n=88 Participants
Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 \[NCT00235872\]) subcutaneously (sc) eow until approval of adalimumab in Japan
|
|---|---|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
Baseline
|
57.8 mm on a scale
Standard Deviation 27.1
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
Week 0
|
-33.6 mm on a scale
Standard Deviation 27.7
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
Week 4
|
-31.8 mm on a scale
Standard Deviation 29.6
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
Week 8
|
-33.7 mm on a scale
Standard Deviation 28.1
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
Week 12
|
-33.3 mm on a scale
Standard Deviation 27.7
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
Week 16
|
-32.5 mm on a scale
Standard Deviation 29.7
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
Week 20
|
-33.0 mm on a scale
Standard Deviation 29.9
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
Week 24
|
-34.0 mm on a scale
Standard Deviation 29.3
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
Week 36
|
-30.6 mm on a scale
Standard Deviation 33.3
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
Week 48
|
-32.1 mm on a scale
Standard Deviation 31.7
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
Week 60
|
-30.4 mm on a scale
Standard Deviation 32.8
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
Week 72
|
-33.4 mm on a scale
Standard Deviation 31.2
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
Week 84
|
-30.8 mm on a scale
Standard Deviation 31.3
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
Week 96
|
-32.0 mm on a scale
Standard Deviation 28.3
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
Week 108
|
-31.9 mm on a scale
Standard Deviation 32.1
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
Week 120
|
-33.5 mm on a scale
Standard Deviation 31.1
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
Week 132
|
-38.9 mm on a scale
Standard Deviation 27.1
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
Final
|
-29.1 mm on a scale
Standard Deviation 35.8
|
SECONDARY outcome
Timeframe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in disability index of the 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 of the ACR criteria by visit
Outcome measures
| Measure |
Adalimumab 40 mg or 80 mg Every Other Week (Eow)
n=88 Participants
Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 \[NCT00235872\]) subcutaneously (sc) eow until approval of adalimumab in Japan
|
|---|---|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Baseline
|
1.4 units on a scale
Standard Deviation 0.7
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Week 0
|
-0.5 units on a scale
Standard Deviation 0.5
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Week 4
|
-0.5 units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Week 8
|
-0.6 units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Week 12
|
-0.6 units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Week 16
|
-0.6 units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Week 20
|
-0.6 units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Week 24
|
-0.6 units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Week 36
|
-0.5 units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Week 48
|
-0.6 units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Week 60
|
-0.5 units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Week 72
|
-0.6 units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Week 84
|
-0.5 units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Week 96
|
-0.5 units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Week 108
|
-0.6 units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Week 120
|
-0.6 units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Week 132
|
-0.7 units on a scale
Standard Deviation 0.9
|
|
Mean Change From Baseline in Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Final
|
-0.5 units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (Final Value)Mean change from baseline(for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in CRP (mg/dL), a component of the ACR criteria, by visit
Outcome measures
| Measure |
Adalimumab 40 mg or 80 mg Every Other Week (Eow)
n=88 Participants
Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 \[NCT00235872\]) subcutaneously (sc) eow until approval of adalimumab in Japan
|
|---|---|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
Baseline
|
4.0 mg/dL
Standard Deviation 2.7
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
Week 0
|
-2.5 mg/dL
Standard Deviation 2.9
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
Week 4
|
-2.4 mg/dL
Standard Deviation 3.0
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
Week 8
|
-2.5 mg/dL
Standard Deviation 2.9
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
Week 12
|
-2.6 mg/dL
Standard Deviation 2.9
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
Week 16
|
-2.6 mg/dL
Standard Deviation 2.8
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
Week 20
|
-2.8 mg/dL
Standard Deviation 2.7
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
Week 24
|
-2.8 mg/dL
Standard Deviation 2.8
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
Week 36
|
-2.8 mg/dL
Standard Deviation 3.0
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
Week 48
|
-2.7 mg/dL
Standard Deviation 3.0
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
Week 60
|
-2.3 mg/dL
Standard Deviation 3.6
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
Week 72
|
-2.5 mg/dL
Standard Deviation 3.1
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
Week 84
|
-2.7 mg/dL
Standard Deviation 3.0
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
Week 96
|
-2.8 mg/dL
Standard Deviation 2.3
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
Week 108
|
-2.9 mg/dL
Standard Deviation 2.4
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
Week 120
|
-2.8 mg/dL
Standard Deviation 2.3
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
Week 132
|
-2.9 mg/dL
Standard Deviation 1.9
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the ACR Criteria by Visit
Final
|
-2.2 mg/dL
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)Population: Subjects were included in this analysis if they had morning stiffness at baseline. Analysis results are as-observed.
The number of subjects with morning stiffness at each visit among those who had morning stiffness at baseline (64).
Outcome measures
| Measure |
Adalimumab 40 mg or 80 mg Every Other Week (Eow)
n=64 Participants
Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 \[NCT00235872\]) subcutaneously (sc) eow until approval of adalimumab in Japan
|
|---|---|
|
Presence of Morning Stiffness by Visit
Week 36
|
22 participants
|
|
Presence of Morning Stiffness by Visit
Week 0
|
24 participants
|
|
Presence of Morning Stiffness by Visit
Week 4
|
29 participants
|
|
Presence of Morning Stiffness by Visit
Week 8
|
26 participants
|
|
Presence of Morning Stiffness by Visit
Week 12
|
25 participants
|
|
Presence of Morning Stiffness by Visit
Week 16
|
24 participants
|
|
Presence of Morning Stiffness by Visit
Week 20
|
23 participants
|
|
Presence of Morning Stiffness by Visit
Week 24
|
23 participants
|
|
Presence of Morning Stiffness by Visit
Week 48
|
19 participants
|
|
Presence of Morning Stiffness by Visit
Week 60
|
23 participants
|
|
Presence of Morning Stiffness by Visit
Week 72
|
20 participants
|
|
Presence of Morning Stiffness by Visit
Week 84
|
21 participants
|
|
Presence of Morning Stiffness by Visit
Week 96
|
15 participants
|
|
Presence of Morning Stiffness by Visit
Week 108
|
15 participants
|
|
Presence of Morning Stiffness by Visit
Week 120
|
7 participants
|
|
Presence of Morning Stiffness by Visit
Week 132
|
1 participants
|
|
Presence of Morning Stiffness by Visit
Final
|
22 participants
|
SECONDARY outcome
Timeframe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)Population: Subjects were included in this analysis if they had morning stiffness at baseline. Analysis results are as-observed.
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in the duration (minutes) of stiffness in the morning.
Outcome measures
| Measure |
Adalimumab 40 mg or 80 mg Every Other Week (Eow)
n=64 Participants
Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 \[NCT00235872\]) subcutaneously (sc) eow until approval of adalimumab in Japan
|
|---|---|
|
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Baseline
|
164.7 minutes
Standard Deviation 333.9
|
|
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Week 0
|
-119.1 minutes
Standard Deviation 273.0
|
|
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Week 4
|
-98.5 minutes
Standard Deviation 214.8
|
|
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Week 8
|
-122.3 minutes
Standard Deviation 271.8
|
|
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Week 12
|
-100.3 minutes
Standard Deviation 234.9
|
|
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Week 16
|
-120.1 minutes
Standard Deviation 273.3
|
|
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Week 20
|
-123.2 minutes
Standard Deviation 277.2
|
|
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Week 24
|
-120.1 minutes
Standard Deviation 277.8
|
|
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Week 36
|
-104.8 minutes
Standard Deviation 238.0
|
|
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Week 48
|
-104.2 minutes
Standard Deviation 243.7
|
|
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Week 60
|
-95.7 minutes
Standard Deviation 245.8
|
|
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Week 72
|
-102.3 minutes
Standard Deviation 250.4
|
|
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Week 84
|
-103.9 minutes
Standard Deviation 253.4
|
|
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Week 96
|
-115.5 minutes
Standard Deviation 256.2
|
|
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Week 108
|
-120.2 minutes
Standard Deviation 351.8
|
|
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Week 120
|
-115.9 minutes
Standard Deviation 257.3
|
|
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Week 132
|
-75.0 minutes
Standard Deviation 89.8
|
|
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Final
|
-97.9 minutes
Standard Deviation 381.3
|
Adverse Events
Adalimumab 40 mg or 80 mg Every Other Week (Eow)
Serious events: 20 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adalimumab 40 mg or 80 mg Every Other Week (Eow)
n=88 participants at risk
Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 \[NCT00235872\]) subcutaneously (sc) eow until approval of adalimumab in Japan
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
1.1%
1/88
|
|
Cardiac disorders
Atrial thrombosis
|
1.1%
1/88
|
|
Cardiac disorders
Cardiac failure
|
1.1%
1/88
|
|
Ear and labyrinth disorders
Vertigo positional
|
1.1%
1/88
|
|
Eye disorders
Cataract
|
1.1%
1/88
|
|
Gastrointestinal disorders
Enterocolitis
|
1.1%
1/88
|
|
Gastrointestinal disorders
Ileus
|
1.1%
1/88
|
|
Infections and infestations
Cellulitis
|
1.1%
1/88
|
|
Infections and infestations
Enteritis infectious
|
1.1%
1/88
|
|
Infections and infestations
Herpes zoster
|
1.1%
1/88
|
|
Infections and infestations
Urinary tract infection
|
2.3%
2/88
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
2.3%
2/88
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
1.1%
1/88
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
1.1%
1/88
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
1.1%
1/88
|
|
Musculoskeletal and connective tissue disorders
Joint destruction
|
3.4%
3/88
|
|
Musculoskeletal and connective tissue disorders
Knee deformity
|
1.1%
1/88
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
4.5%
4/88
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
1.1%
1/88
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
1.1%
1/88
|
|
Renal and urinary disorders
Renal failure acute
|
1.1%
1/88
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.1%
1/88
|
Other adverse events
| Measure |
Adalimumab 40 mg or 80 mg Every Other Week (Eow)
n=88 participants at risk
Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 \[NCT00235872\]) subcutaneously (sc) eow until approval of adalimumab in Japan
|
|---|---|
|
Investigations
DNA antibody positive
|
10.2%
9/88
|
|
Investigations
Protein urine present
|
5.7%
5/88
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
7/88
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
5.7%
5/88
|
|
Nervous system disorders
Headache
|
8.0%
7/88
|
|
Psychiatric disorders
Insomnia
|
10.2%
9/88
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.2%
9/88
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
10.2%
9/88
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.1%
8/88
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
8.0%
7/88
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal discomfort
|
5.7%
5/88
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.2%
9/88
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.2%
9/88
|
|
Skin and subcutaneous tissue disorders
Eczema
|
9.1%
8/88
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.7%
5/88
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
5.7%
5/88
|
|
Blood and lymphatic system disorders
Anaemia
|
8.0%
7/88
|
|
Ear and labyrinth disorders
Vertigo
|
5.7%
5/88
|
|
Gastrointestinal disorders
Constipation
|
14.8%
13/88
|
|
Gastrointestinal disorders
Dental caries
|
12.5%
11/88
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
8/88
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.8%
6/88
|
|
Gastrointestinal disorders
Gingivitis
|
6.8%
6/88
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.8%
6/88
|
|
Gastrointestinal disorders
Stomatitis
|
6.8%
6/88
|
|
Gastrointestinal disorders
Nausea
|
5.7%
5/88
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
5/88
|
|
General disorders
Adverse drug reaction
|
29.5%
26/88
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
5.7%
5/88
|
|
Immune system disorders
Seasonal allergy
|
6.8%
6/88
|
|
Infections and infestations
Nasopharyngitis
|
60.2%
53/88
|
|
Infections and infestations
Bronchitis
|
13.6%
12/88
|
|
Infections and infestations
Upper respiratory tract infection
|
10.2%
9/88
|
|
Infections and infestations
Pharyngitis
|
6.8%
6/88
|
|
Infections and infestations
Tinea infection
|
5.7%
5/88
|
|
Injury, poisoning and procedural complications
Contusion
|
12.5%
11/88
|
|
Injury, poisoning and procedural complications
Fall
|
10.2%
9/88
|
|
Investigations
Antinuclear antibody positive
|
15.9%
14/88
|
Additional Information
Global Medical Services
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Phone: 1-800-633-9110
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