Trial Outcomes & Findings for Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis (NCT NCT00235872)
NCT ID: NCT00235872
Last Updated: 2011-04-11
Results Overview
Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20/50/70, 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 (DI-HAQ), and 5) C-reactive protein (CRP) at each visit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
309 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
2011-04-11
Participant Flow
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
|
309
|
|
Overall Study
COMPLETED
|
162
|
|
Overall Study
NOT COMPLETED
|
147
|
Reasons for withdrawal
| Measure |
Adalimumab 40 mg Eow
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
|
|---|---|
|
Overall Study
Adverse Event
|
34
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
50
|
|
Overall Study
Administrative reason
|
61
|
Baseline Characteristics
Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Adalimumab 40 mg Eow
n=309 Participants
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
|
|---|---|
|
Age, Customized
< 40 years
|
35 participants
n=99 Participants
|
|
Age, Customized
Between 40 and 49 years
|
57 participants
n=99 Participants
|
|
Age, Customized
Between 50 and 59 years
|
111 participants
n=99 Participants
|
|
Age, Customized
>/= 60 years
|
106 participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
249 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=99 Participants
|
|
Region of Enrollment
Japan
|
309 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: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20/50/70, 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 (DI-HAQ), and 5) C-reactive protein (CRP) at each visit.
Outcome measures
| Measure |
Adalimumab 40 mg Eow
n=309 Participants
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
|
|---|---|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 0 ACR20
|
104 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 0 ACR50
|
52 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 0 ACR70
|
22 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 4 ACR20
|
157 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 4 ACR50
|
74 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 4 ACR70
|
30 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 8 ACR20
|
154 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 8 ACR50
|
74 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 8 ACR70
|
40 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 12 ACR20
|
154 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 12 ACR50
|
83 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 12 ACR70
|
39 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 16 ACR20
|
148 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 16 ACR50
|
81 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 16 ACR70
|
46 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 20 ACR20
|
155 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 20 ACR50
|
77 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 20 ACR70
|
46 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 24 ACR20
|
155 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 24 ACR50
|
91 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 24 ACR70
|
46 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 36 ACR20
|
163 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 36 ACR50
|
99 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 36 ACR70
|
50 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 48 ACR20
|
158 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 48 ACR50
|
99 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 48 ACR70
|
52 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 60 ACR20
|
141 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 60 ACR50
|
86 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 60 ACR70
|
47 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 72 ACR20
|
118 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 72 ACR50
|
75 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 72 ACR70
|
45 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 84 ACR20
|
92 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 84 ACR50
|
63 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 84 ACR70
|
33 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 96 ACR20
|
81 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 96 ACR50
|
49 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 96 ACR70
|
24 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 108 ACR20
|
72 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 108 ACR50
|
43 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 108 ACR70
|
27 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 120 ACR20
|
63 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 120 ACR50
|
41 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 120 ACR70
|
23 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 132 ACR20
|
68 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 132 ACR50
|
49 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 132 ACR70
|
27 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 144 ACR20
|
63 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 144 ACR50
|
47 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 144 ACR70
|
25 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 156 ACR20
|
61 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 156 ACR50
|
47 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 156 ACR70
|
27 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 168 ACR20
|
62 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 168 ACR50
|
42 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 168 ACR70
|
28 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 180 ACR20
|
47 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 180 ACR50
|
33 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 180 ACR70
|
16 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 192 ACR20
|
24 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 192 ACR50
|
16 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 192 ACR70
|
8 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 204 ACR20
|
8 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 204 ACR50
|
7 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 204 ACR70
|
4 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 216 ACR20
|
1 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 216 ACR50
|
1 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Week 216 ACR70
|
0 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Final Value ACR20
|
166 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Final Value ACR50
|
104 participants
|
|
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Final Value ACR70
|
58 participants
|
SECONDARY outcome
Timeframe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
Mean change from Baseline in TJC (max=68) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 \[before dosing\] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 \[before dosing\] of the M03-651 study.
Outcome measures
| Measure |
Adalimumab 40 mg Eow
n=309 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 American College of Rheumatology (ACR) by Visit
TJC Baseline (n=309)
|
22.3 TJC
Standard Deviation 11.59
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 0 (n=309)
|
-7.2 TJC
Standard Deviation 10.10
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 4 (n=307)
|
-10.0 TJC
Standard Deviation 10.10
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 8 (n=304)
|
-10.6 TJC
Standard Deviation 10.37
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 12 (n=298)
|
-11.0 TJC
Standard Deviation 10.70
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 16 (n=287)
|
-11.5 TJC
Standard Deviation 10.88
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 20 (n=271)
|
-12.3 TJC
Standard Deviation 10.84
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 24 (n=261)
|
-13.3 TJC
Standard Deviation 10.72
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 36 (n=245)
|
-14.3 TJC
Standard Deviation 10.43
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 48(n=232)
|
-14.9 TJC
Standard Deviation 10.88
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 60 (n=209)
|
-15.4 TJC
Standard Deviation 10.75
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 72 (n=162)
|
-15.9 TJC
Standard Deviation 10.86
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 84 (n=125)
|
-16.0 TJC
Standard Deviation 10.27
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 96 (n=102)
|
-16.0 TJC
Standard Deviation 9.74
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 108 (n=95)
|
-16.0 TJC
Standard Deviation 9.49
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 120 (n=91)
|
-15.9 TJC
Standard Deviation 9.42
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 132 (n=90)
|
-16.1 TJC
Standard Deviation 10.00
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 144 (n=87)
|
-16.4 TJC
Standard Deviation 10.15
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 156(n=82)
|
-16.2 TJC
Standard Deviation 11.63
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 168 (n=78)
|
-17.7 TJC
Standard Deviation 10.43
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 180 (n=59)
|
-17.7 TJC
Standard Deviation 11.39
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 192 (n=33)
|
-17.8 TJC
Standard Deviation 11.75
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 204 (n=9)
|
-22.4 TJC
Standard Deviation 8.50
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Week 216 (n=1)
|
-24.0 TJC
Standard Deviation 0
|
|
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
TJC Final Value (n=309)
|
-12.5 TJC
Standard Deviation 12.36
|
SECONDARY outcome
Timeframe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
Mean change from Baseline in SJC (max=66) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing)\] of the M02-575 study; for the M02-575 rescue arm, the baseline was defined as the Week 0 (before dosing) of the M03-651 study.
Outcome measures
| Measure |
Adalimumab 40 mg Eow
n=309 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 American College of Rheumatology (ACR) by Visit
Baseline (n=309)
|
17.6 SJC
Standard Deviation 8.26
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 0 (n=309)
|
-6.1 SJC
Standard Deviation 7.69
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 4 (n=307)
|
-8.5 SJC
Standard Deviation 7.72
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 8 (n=304)
|
-8.6 SJC
Standard Deviation 8.31
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 12 (n=298)
|
-9.0 SJC
Standard Deviation 8.09
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 16 (n=287)
|
-9.0 SJC
Standard Deviation 8.08
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 20 (n=271)
|
-10.1 SJC
Standard Deviation 7.88
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 24 (n=261)
|
-10.9 SJC
Standard Deviation 7.91
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 36 (n=245)
|
-11.7 SJC
Standard Deviation 7.83
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 48 (n=232)
|
-11.9 SJC
Standard Deviation 8.20
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 60 (n=209)
|
-12.2 SJC
Standard Deviation 8.50
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 72 (n=162)
|
-12.8 SJC
Standard Deviation 8.20
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 84 (n=125)
|
-13.7 SJC
Standard Deviation 7.73
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 96 (n=102)
|
-13.6 SJC
Standard Deviation 7.50
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 108 (n=95)
|
-13.5 SJC
Standard Deviation 7.68
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 120 (n=91)
|
-13.8 SJC
Standard Deviation 7.75
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 132 (n=90)
|
-13.8 SJC
Standard Deviation 8.17
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 144 (n=87)
|
-14.3 SJC
Standard Deviation 7.44
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 156 (n=82)
|
-14.0 SJC
Standard Deviation 7.76
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 168 (n=72)
|
-14.7 SJC
Standard Deviation 7.89
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 180 (n=59)
|
-15.3 SJC
Standard Deviation 7.76
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 192 (n=33)
|
-17.5 SJC
Standard Deviation 8.30
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 204 (n=9)
|
-20.0 SJC
Standard Deviation 4.97
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Week 216 (n=1)
|
-86.0 SJC
Standard Deviation 0
|
|
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
Final Value (n=309)
|
-10.6 SJC
Standard Deviation 8.93
|
SECONDARY outcome
Timeframe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
Change from Baseline in PGA (a visual analog scale from 0-100 mm, with 0 being the absence of disease activity and 100 mm being very strong disease activity, a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.
Outcome measures
| Measure |
Adalimumab 40 mg Eow
n=309 Participants
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
|
|---|---|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Baseline (n=309)
|
67.2 mm on a scale
Standard Deviation 19.67
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 0 (n=309)
|
-20.0 mm on a scale
Standard Deviation 25.83
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 4 (n=307)
|
-27.9 mm on a scale
Standard Deviation 25.80
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 8 (n=304)
|
-28.1 mm on a scale
Standard Deviation 26.69
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 12 (n=298)
|
-28.3 mm on a scale
Standard Deviation 26.54
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 16 (n=286)
|
-29.9 mm on a scale
Standard Deviation 26.26
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 20 (n=271)
|
-33.1 mm on a scale
Standard Deviation 25.59
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 24 (n=261)
|
-35.1 mm on a scale
Standard Deviation 25.85
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 36 (n=245)
|
-37.3 mm on a scale
Standard Deviation 24.76
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 48 (n=232)
|
-37.8 mm on a scale
Standard Deviation 25.08
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 60 (n=209)
|
-38.1 mm on a scale
Standard Deviation 25.75
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 72 (n=162)
|
-39.6 mm on a scale
Standard Deviation 24.97
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 84 (n=125)
|
-43.1 mm on a scale
Standard Deviation 23.43
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 96 (n=102)
|
-42.8 mm on a scale
Standard Deviation 22.35
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 108 (n=94)
|
-43.6 mm on a scale
Standard Deviation 23.47
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 120 (n=91)
|
-42.2 mm on a scale
Standard Deviation 24.68
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 132 (n=90)
|
-42.9 mm on a scale
Standard Deviation 24.79
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 144 (n=87)
|
-42.3 mm on a scale
Standard Deviation 23.80
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 156 (n=82)
|
-44.3 mm on a scale
Standard Deviation 23.73
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 168 (n=78)
|
-45.6 mm on a scale
Standard Deviation 23.23
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 180 (n=59)
|
-45.0 mm on a scale
Standard Deviation 26.12
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 192 (n=33)
|
-46.1 mm on a scale
Standard Deviation 26.10
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 204 (n=9)
|
-60.1 mm on a scale
Standard Deviation 15.52
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Week 216 (n=1)
|
-64.0 mm on a scale
Standard Deviation 0
|
|
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
Final Value (n=309)
|
-30.2 mm on a scale
Standard Deviation 30.04
|
SECONDARY outcome
Timeframe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
Change from Baseline in Subject's Global Assessment of Disease Activity (a visual analog scale from 0-100 mm (0 being absence of disease activity and 100 being very strong disease activity), a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.
Outcome measures
| Measure |
Adalimumab 40 mg Eow
n=309 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, a Component of the ACR Criteria by Visit
Baseline (n=309)
|
63.5 mm on unit scale
Standard Deviation 24.00
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 0 (n=309)
|
-14.2 mm on unit scale
Standard Deviation 26.93
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 4 (n=307)
|
-19.4 mm on unit scale
Standard Deviation 28.30
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 8 (n=304)
|
-19.8 mm on unit scale
Standard Deviation 28.22
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 12 (n=298)
|
-21.1 mm on unit scale
Standard Deviation 28.62
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 16 (n=287)
|
-21.0 mm on unit scale
Standard Deviation 28.63
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 20 (n=271)
|
-23.0 mm on unit scale
Standard Deviation 29.14
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 24 (n=261)
|
-23.9 mm on unit scale
Standard Deviation 29.06
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 36 (n=244)
|
-26.9 mm on unit scale
Standard Deviation 29.38
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 48 (n=231)
|
-27.3 mm on unit scale
Standard Deviation 28.77
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 60 (n=209)
|
-28.2 mm on unit scale
Standard Deviation 29.86
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 72 (n=162)
|
-29.4 mm on unit scale
Standard Deviation 27.90
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 84 (n=125)
|
-30.4 mm on unit scale
Standard Deviation 29.49
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 96 (n=102)
|
-31.7 mm on unit scale
Standard Deviation 25.73
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 108 (n=95)
|
-28.0 mm on unit scale
Standard Deviation 27.73
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 120 (n=90)
|
-27.9 mm on unit scale
Standard Deviation 26.64
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 132 (n=90)
|
-29.2 mm on unit scale
Standard Deviation 27.73
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 144 (n=87)
|
-28.6 mm on unit scale
Standard Deviation 29.54
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 156 (n=82)
|
-29.7 mm on unit scale
Standard Deviation 28.72
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 168 (n=78)
|
-29.7 mm on unit scale
Standard Deviation 30.14
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 180 (n=59)
|
-30.1 mm on unit scale
Standard Deviation 30.45
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 192 (n=33)
|
-22.3 mm on unit scale
Standard Deviation 32.92
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 204 (n=8)
|
-48.1 mm on unit scale
Standard Deviation 30.98
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 216 (n=1)
|
-85.0 mm on unit scale
Standard Deviation 0
|
|
Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Final Value (n=309)
|
-20.7 mm on unit scale
Standard Deviation 31.77
|
SECONDARY outcome
Timeframe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
Change from Baseline in subject's assessment of pain (a visual analog scale from 0-100 mm \[0 being no pain and 100 being unbearable pain\], a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study.
Outcome measures
| Measure |
Adalimumab 40 mg Eow
n=309 Participants
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
|
|---|---|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Baseline (n=309)
|
61.3 mm on unit scale
Standard Deviation 24.03
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 0 (n=309)
|
-12.3 mm on unit scale
Standard Deviation 27.64
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 4 (n=307)
|
-17.0 mm on unit scale
Standard Deviation 28.65
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 8 (n=304)
|
-17.7 mm on unit scale
Standard Deviation 27.78
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 12 (n=298)
|
-19.1 mm on unit scale
Standard Deviation 27.66
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 16 (n=287)
|
-19.6 mm on unit scale
Standard Deviation 27.42
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 20 (n=271)
|
-22.2 mm on unit scale
Standard Deviation 27.87
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 24 (n=261)
|
-22.7 mm on unit scale
Standard Deviation 27.00
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 36 (n=244)
|
-26.0 mm on unit scale
Standard Deviation 27.55
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 48 (n=231)
|
-26.5 mm on unit scale
Standard Deviation 28.11
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 60 (n=209)
|
-27.1 mm on unit scale
Standard Deviation 28.53
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 72 (n=162)
|
-28.6 mm on unit scale
Standard Deviation 26.56
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 84 (n=125)
|
-28.1 mm on unit scale
Standard Deviation 28.65
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 96 (n=102)
|
-30.0 mm on unit scale
Standard Deviation 24.27
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 108 (n=95)
|
-28.6 mm on unit scale
Standard Deviation 24.40
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 120 (n=90)
|
-26.3 mm on unit scale
Standard Deviation 25.26
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 132 (n=90)
|
-28.5 mm on unit scale
Standard Deviation 27.13
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 144 (n=87)
|
-27.6 mm on unit scale
Standard Deviation 27.98
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 156 (n=82)
|
-29.7 mm on unit scale
Standard Deviation 26.65
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 168 (n=78)
|
-29.4 mm on unit scale
Standard Deviation 27.62
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 180 (n=59)
|
-29.9 mm on unit scale
Standard Deviation 25.63
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 192 (n=33)
|
-23.5 mm on unit scale
Standard Deviation 29.13
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 204 (n=9)
|
-39.7 mm on unit scale
Standard Deviation 30.54
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Week 216 (n=1)
|
-86.0 mm on unit scale
Standard Deviation 0
|
|
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
Final Value (n=309)
|
-20.1 mm on unit scale
Standard Deviation 31.24
|
SECONDARY outcome
Timeframe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
Mean change from Baseline in DI-HAQ overall score (includes 20 questions assessing physical function in 8 domains - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities). Each question is on a scale of 0-3 mm 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. DI-HAQ is derived based on the mean of individual responses not the total of individual questions
Outcome measures
| Measure |
Adalimumab 40 mg Eow
n=309 Participants
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
|
|---|---|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Baseline (n=309)
|
1.5 mm on a scale
Standard Deviation 0.75
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 0 (n=309)
|
-0.2 mm on a scale
Standard Deviation 0.49
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 4 (n=307)
|
-0.3 mm on a scale
Standard Deviation 0.53
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 8 (n=304)
|
-0.3 mm on a scale
Standard Deviation 0.51
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 12 (n=298)
|
-0.3 mm on a scale
Standard Deviation 0.53
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 16 (n=287)
|
-0.3 mm on a scale
Standard Deviation 0.54
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 20 (n=271)
|
-0.3 mm on a scale
Standard Deviation 0.56
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 24 (n=261)
|
-0.4 mm on a scale
Standard Deviation 0.53
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 36 (n=244)
|
-0.4 mm on a scale
Standard Deviation 0.58
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 48 (n=231)
|
-0.4 mm on a scale
Standard Deviation 0.56
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 60 (n=209)
|
-0.5 mm on a scale
Standard Deviation 0.57
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 72 (n=162)
|
-0.5 mm on a scale
Standard Deviation 0.52
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 84 (n=125)
|
-0.5 mm on a scale
Standard Deviation 0.59
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 96 (n=102)
|
-0.5 mm on a scale
Standard Deviation 0.58
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 108 (n=95)
|
-0.5 mm on a scale
Standard Deviation 0.55
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 120 (n=90)
|
-0.4 mm on a scale
Standard Deviation 0.62
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 132 (n=90)
|
-0.5 mm on a scale
Standard Deviation 0.58
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 144 (n=87)
|
-0.5 mm on a scale
Standard Deviation 0.57
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 156 (n=82)
|
-0.5 mm on a scale
Standard Deviation 0.58
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 168 (n=78)
|
-0.6 mm on a scale
Standard Deviation 0.56
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 180 (n=59)
|
-0.5 mm on a scale
Standard Deviation 0.59
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 192 (n=33)
|
-0.5 mm on a scale
Standard Deviation 0.55
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 204 (n=9)
|
-0.7 mm on a scale
Standard Deviation 0.48
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 216 (n=1)
|
-1.4 mm on a scale
Standard Deviation 0
|
|
Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit
Final Visit (n=309)
|
-0.3 mm on a scale
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
Mean change from Baseline in CRP (mg/dL), a component of the ACR criteria by visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 \[before dosing\] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 \[before dosing\] of the M03-651 study.
Outcome measures
| Measure |
Adalimumab 40 mg Eow
n=309 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), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Baseline (n=-309)
|
4.7 mg/dL
Standard Deviation 3.30
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 0 (n=309)
|
-1.2 mg/dL
Standard Deviation 3.02
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 4 (n=307)
|
-1.7 mg/dL
Standard Deviation 3.38
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 8 (n=303)
|
-1.6 mg/dL
Standard Deviation 3.69
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 12 (n=298)
|
-1.5 mg/dL
Standard Deviation 3.33
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 16 (n=287)
|
-1.6 mg/dL
Standard Deviation 3.58
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 20 (n=271)
|
-1.8 mg/dL
Standard Deviation 3.60
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 24 (n=261)
|
-1.9 mg/dL
Standard Deviation 3.51
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 36 (n=245)
|
-2.2 mg/dL
Standard Deviation 3.55
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 48 (n=231)
|
-2.3 mg/dL
Standard Deviation 3.66
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 60 (n=209)
|
-2.5 mg/dL
Standard Deviation 3.46
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 72 (n=162)
|
-2.4 mg/dL
Standard Deviation 3.77
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 84 (n=125)
|
-2.9 mg/dL
Standard Deviation 3.90
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 96 (n=102)
|
-3.3 mg/dL
Standard Deviation 3.59
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 108 (n=95)
|
-3.1 mg/dL
Standard Deviation 3.63
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 120 (n=91)
|
-2.7 mg/dL
Standard Deviation 4.02
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 132 (n=90)
|
-3.3 mg/dL
Standard Deviation 3.45
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 144 (n=87)
|
-3.3 mg/dL
Standard Deviation 3.37
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 156 (n=82)
|
-3.5 mg/dL
Standard Deviation 3.57
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 168 (n=78)
|
-3.4 mg/dL
Standard Deviation 3.89
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 180 (n=58)
|
-3.2 mg/dL
Standard Deviation 4.55
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 192 (n=33)
|
-4.2 mg/dL
Standard Deviation 4.21
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 204 (n=9)
|
-5.4 mg/dL
Standard Deviation 6.38
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Week 216 (n=1)
|
-4.0 mg/dL
Standard Deviation 0
|
|
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
Final Value (n=309)
|
-1.7 mg/dL
Standard Deviation 4.01
|
SECONDARY outcome
Timeframe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
The number of subjects with morning stiffness at each visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 \[before dosing\] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 \[before dosing\] of the M03-651 study.
Outcome measures
| Measure |
Adalimumab 40 mg Eow
n=309 Participants
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
|
|---|---|
|
Presence of Morning Stiffness
Week 0
|
182 participants
|
|
Presence of Morning Stiffness
Week 4
|
173 participants
|
|
Presence of Morning Stiffness
Week 8
|
168 participants
|
|
Presence of Morning Stiffness
Week 12
|
167 participants
|
|
Presence of Morning Stiffness
Week 16
|
154 participants
|
|
Presence of Morning Stiffness
Week 20
|
148 participants
|
|
Presence of Morning Stiffness
Week 24
|
138 participants
|
|
Presence of Morning Stiffness
Week 36
|
106 participants
|
|
Presence of Morning Stiffness
Week 48
|
93 participants
|
|
Presence of Morning Stiffness
Week 60
|
91 participants
|
|
Presence of Morning Stiffness
Week 72
|
68 participants
|
|
Presence of Morning Stiffness
Week 84
|
47 participants
|
|
Presence of Morning Stiffness
Week 96
|
39 participants
|
|
Presence of Morning Stiffness
Week 108
|
29 participants
|
|
Presence of Morning Stiffness
Week 120
|
29 participants
|
|
Presence of Morning Stiffness
Week 132
|
29 participants
|
|
Presence of Morning Stiffness
Week 144
|
32 participants
|
|
Presence of Morning Stiffness
Week 156
|
20 participants
|
|
Presence of Morning Stiffness
Week 168
|
19 participants
|
|
Presence of Morning Stiffness
Week 180
|
16 participants
|
|
Presence of Morning Stiffness
Week 192
|
11 participants
|
|
Presence of Morning Stiffness
Week 204
|
1 participants
|
|
Presence of Morning Stiffness
Week 216
|
0 participants
|
|
Presence of Morning Stiffness
Final Value
|
141 participants
|
SECONDARY outcome
Timeframe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
Mean change (minutes) from Baseline in morning stiffness (duration). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 \[before dosing\] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 \[before dosing\] of the M03-651 study.
Outcome measures
| Measure |
Adalimumab 40 mg Eow
n=309 Participants
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
|
|---|---|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Baseline (n=246)
|
221.8 minutes
Standard Deviation 374.72
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Week 0 (n=182)
|
-48.9 minutes
Standard Deviation 292.93
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Week 4 (n=173)
|
-64.2 minutes
Standard Deviation 307.03
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Week 8 (n=168)
|
-69.4 minutes
Standard Deviation 387.21
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Week 12 (n=167)
|
-79.7 minutes
Standard Deviation 348.20
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Week 16 (n=154)
|
-64.0 minutes
Standard Deviation 338.37
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Week 20 (n=148)
|
-87.9 minutes
Standard Deviation 318.04
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Week 24 (n=138)
|
-104.9 minutes
Standard Deviation 293.66
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Week 36 (n=106)
|
-79.9 minutes
Standard Deviation 287.89
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Week 48 (n=93)
|
-86.5 minutes
Standard Deviation 281.83
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Week 60 (n=91)
|
-95.0 minutes
Standard Deviation 363.90
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Week 72 (n=68)
|
-86.4 minutes
Standard Deviation 247.30
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Week 84 (n=47)
|
-30.5 minutes
Standard Deviation 145.23
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Week 96 (n=39)
|
-95.6 minutes
Standard Deviation 248.27
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Week 108 (n=29)
|
-97.4 minutes
Standard Deviation 263.44
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Week 120 (n=29)
|
-94.8 minutes
Standard Deviation 278.36
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Week 132 (n=29)
|
-116.9 minutes
Standard Deviation 279.96
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Week 144 (n=32)
|
-34.2 minutes
Standard Deviation 372.50
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Week 156 (n=20)
|
-46.3 minutes
Standard Deviation 169.08
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Week 168 (n=19)
|
-138.0 minutes
Standard Deviation 338.26
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Week 180 (n=16)
|
-98.8 minutes
Standard Deviation 139.98
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Week 192 (n=11)
|
-47.7 minutes
Standard Deviation 113.65
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Week 204 (n=1)
|
30.0 minutes
Standard Deviation 0
|
|
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
Final Value (n=238)
|
-57.9 minutes
Standard Deviation 358.24
|
SECONDARY outcome
Timeframe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
The number of subjects who were positive for rheumatoid factor (RF) at each visit. RF considered negative if \<=20 IU/mL and positive if \>20 IU/mL.
Outcome measures
| Measure |
Adalimumab 40 mg Eow
n=309 Participants
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
|
|---|---|
|
Presence of Rheumatoid Factor (RF)
Week 24
|
248 participants
|
|
Presence of Rheumatoid Factor (RF)
Week 48
|
191 participants
|
|
Presence of Rheumatoid Factor (RF)
Week 72
|
142 participants
|
|
Presence of Rheumatoid Factor (RF)
Week 96
|
92 participants
|
|
Presence of Rheumatoid Factor (RF)
Week 120
|
69 participants
|
|
Presence of Rheumatoid Factor (RF)
Week 144
|
66 participants
|
|
Presence of Rheumatoid Factor (RF)
Week 168
|
60 participants
|
|
Presence of Rheumatoid Factor (RF)
Week 192
|
31 participants
|
|
Presence of Rheumatoid Factor (RF)
Week 216
|
1 participants
|
|
Presence of Rheumatoid Factor (RF)
Final Value
|
250 participants
|
SECONDARY outcome
Timeframe: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)Population: Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data.
Mean change from Baseline in RF (IU/mL). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 \[before dosing\] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 \[before dosing\] of the M03-651 study.
Outcome measures
| Measure |
Adalimumab 40 mg Eow
n=309 Participants
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
|
|---|---|
|
Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit
Baseline (n=308)
|
293.7 IU/mL
Standard Deviation 412.95
|
|
Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit
Week 24 (n=308)
|
-37.6 IU/mL
Standard Deviation 303.19
|
|
Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit
Week 48 (n=243)
|
-82.1 IU/mL
Standard Deviation 322.10
|
|
Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit
Week 72 (n=185)
|
-104.2 IU/mL
Standard Deviation 286.58
|
|
Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit
Week 120 (n=93)
|
-101.0 IU/mL
Standard Deviation 344.41
|
|
Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit
Week 144 (n=88)
|
-111.1 IU/mL
Standard Deviation 374.58
|
|
Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit
Week 168 (n=80)
|
-139.1 IU/mL
Standard Deviation 357.30
|
|
Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit
Week 192 (n=41)
|
-143.0 IU/mL
Standard Deviation 428.18
|
|
Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit
Week 216 (n=4)
|
-76.0 IU/mL
Standard Deviation 128.47
|
|
Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit
Fina Value (n=308)
|
-55.9 IU/mL
Standard Deviation 338.06
|
|
Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit
Week 96 (n=112)
|
-59.7 IU/mL
Standard Deviation 445.83
|
Adverse Events
Adalimumab 40 mg Eow
Serious events: 111 serious events
Other events: 285 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adalimumab 40 mg Eow
n=309 participants at risk
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Abscess
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Gastrointestinal disorders
Anal fistula
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Blood and lymphatic system disorders
Anemia
|
0.65%
2/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Arthritis bacterial
|
0.65%
2/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Musculoskeletal and connective tissue disorders
Atlantoaxial instability
|
0.65%
2/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.65%
2/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Investigations
Blood Beta-D-Glucan increased
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Bronchiectasis
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Bronchitis
|
1.3%
4/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Investigations
C-reactive protein increased
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Renal and urinary disorders
Calculus ureteric
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Renal and urinary disorders
Calculus urinary
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Cardiac disorders
Cardiac failure
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Cardiac disorders
Cardiac tamponade
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Eye disorders
Cataract
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Cellulitis
|
1.3%
4/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Nervous system disorders
Cerebral hemorrhage
|
0.97%
3/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Nervous system disorders
Cerebral infarction
|
0.65%
2/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Nervous system disorders
Cerebral ischaemia
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Nervous system disorders
Cervical cord compression
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Nervous system disorders
Cervical myelopathy
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
General disorders
Chest discomfort
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Investigations
Chest x-ray abnormal
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Chronic sinusitis
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Gastrointestinal disorders
Colonic polyp
|
0.65%
2/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Investigations
Computerised tomogram abnormal
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Cardiac disorders
Coronary artery disease
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Respiratory, thoracic and mediastinal disorders
Cryptogenic organizing pneumonia
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Psychiatric disorders
Decreased activity
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Vascular disorders
Deep vein thrombosis
|
0.65%
2/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Metabolism and nutrition disorders
Dehydration
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Congenital, familial and genetic disorders
Dermoid cyst of ovary
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Gastrointestinal disorders
Diarrhoea
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Gastrointestinal disorders
Enterocolitis
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Entertis infectious
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Femur fracture
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Metabolism and nutrition disorders
Foot deformity
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Gastroenteritis
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Musculoskeletal and connective tissue disorders
Hand deformity
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Nervous system disorders
Headache
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Investigations
Hepatic enzyme increased
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Herpes ophthalmic
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Herpes zoster
|
1.3%
4/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
General disorders
Injection site erythema
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.65%
2/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Musculoskeletal and connective tissue disorders
Joint destruction
|
3.9%
12/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Nervous system disorders
Lacunar infarction
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Metabolism and nutrition disorders
Lumbar spinal stenosis
|
0.65%
2/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Lung infection
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
General disorders
Malaise
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Injury, poisoning and procedural complications
Medical device complication
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Respiratory, thoracic and mediastinal disorders
Middle lobe syndrome
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Metabolism and nutrition disorders
Musculoskeletal stiffness
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Nervous system disorders
Myelopathy
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Gastrointestinal disorders
Nausea
|
0.65%
2/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Nervous system disorders
Nervous system disorder
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurilemmoma benign
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Metabolism and nutrition disorders
Osteoarthritis
|
0.65%
2/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Osteomyelitis
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Metabolism and nutrition disorders
Osteonecrosis
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Cardiac disorders
Palpitations
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Reproductive system and breast disorders
Parovarian cyst
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Cardiac disorders
Pericarditis
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.65%
2/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Pneumonia
|
2.3%
7/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Pneumonia bacterial
|
0.65%
2/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.65%
2/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Pyelonephritis
|
0.65%
2/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Pyelonephritis acute
|
0.97%
3/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Pyothorax
|
0.65%
2/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
General disorders
Pyrexia
|
0.97%
3/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Nervous system disorders
Radiculopathy
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.65%
2/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Renal and urinary disorders
Renal failure chronic
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Renal and urinary disorders
Renal infarct
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
8.1%
25/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Scapula fracture
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Immune system disorders
Secondary amyloidosis
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Sepsis
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.97%
3/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.6%
5/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.65%
2/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Blood and lymphatic system disorders
Splenic haemorrhage
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Congenital, familial and genetic disorders
Spondylolisthesis
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Staphylococcal bacteremia
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Staphylococcal infection
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Nervous system disorders
Subarachnoid hemorrhage
|
0.65%
2/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
1.3%
4/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
1.3%
4/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Nervous system disorders
Transient ischaemic attack
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Urinary tract infection
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Vascular disorders
Vasodilatation
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Gastrointestinal disorders
Vomiting
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Investigations
Weight decreased
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Endocarditis
|
0.32%
1/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
Other adverse events
| Measure |
Adalimumab 40 mg Eow
n=309 participants at risk
Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.5%
17/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
General disorders
Adverse drug reaction
|
23.6%
73/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Blood and lymphatic system disorders
Anaemia
|
5.2%
16/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Investigations
Antinuclear antibody positive
|
12.3%
38/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Investigations
Blood urine present
|
6.8%
21/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Bronchitis
|
12.0%
37/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Gastrointestinal disorders
Constipation
|
13.6%
42/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Injury, poisoning and procedural complications
Contusion
|
12.3%
38/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.4%
26/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Investigations
DNA antibody positive
|
16.2%
50/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Gastrointestinal disorders
Dental caries
|
7.8%
24/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.2%
16/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Gastrointestinal disorders
Diarrhoea
|
9.7%
30/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Nervous system disorders
Dizziness
|
5.5%
17/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Skin and subcutaneous tissue disorders
Eczema
|
10.0%
31/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.4%
26/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Injury, poisoning and procedural complications
Fall
|
6.1%
19/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.5%
17/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Gastrointestinal disorders
Gastritis
|
5.5%
17/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Gastroenteritis
|
5.2%
16/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
5.5%
17/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Nervous system disorders
Headache
|
10.7%
33/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
5.2%
16/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Vascular disorders
Hypertension
|
8.1%
25/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Influenza
|
5.5%
17/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
General disorders
Injection site erythema
|
9.7%
30/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
General disorders
Injection site reaction
|
8.1%
25/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Psychiatric disorders
Insomnia
|
12.6%
39/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
6.8%
21/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.8%
18/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Nasopharyngitis
|
45.0%
139/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Gastrointestinal disorders
Nausea
|
7.8%
24/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
General disorders
Oedema peripheral
|
6.1%
19/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
6.1%
19/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Pharyngitis
|
8.7%
27/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.5%
20/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.8%
18/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.0%
37/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
General disorders
Pyrexia
|
8.4%
26/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.6%
39/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
7.1%
22/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Gastrointestinal disorders
Stomatitis
|
6.8%
21/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Infections and infestations
Upper respiratory tract infection
|
11.7%
36/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
8.4%
26/309 • Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
|
Additional Information
Global Medical Services
Abbott
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER