A Phase 3 interventional study of adalimumab in Rheumatoid Arthritis, sponsored by Abbott. Completed at 25 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2011-04-11.
Sponsored by Abbott · Phase 3, Interventional, and Treatment
The purpose of the study is to assess the long-term safety and tolerability of repeated administration of adalimumab in Japanese subjects with rheumatoid arthritis.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 309 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A subject who experienced any of the following during prior study:
History of following during prior study:
Biological: adalimumab
40 mg eow, sc
Also known as: ABT-D2E7, Humira
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
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.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit
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.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit
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.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit
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.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).
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
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.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).
Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit
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.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value).
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
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
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit
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.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Presence of Morning Stiffness
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.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit
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.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Presence of Rheumatoid Factor (RF)
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.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit
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.
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value)
| Milestone | Adalimumab 40 mg Eow |
|---|---|
| Started | 309 |
| Completed | 162 |
| Not completed | 147 |
| Withdrew: Adverse event | 34 |
| Withdrew: Death | 1 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Withdrawal by subject | 50 |
| Withdrew: Administrative reason | 61 |
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.
| participants | Adalimumab 40 mg Eow |
|---|---|
| Week 0 ACR20 | 104 |
| Week 0 ACR50 | 52 |
| Week 0 ACR70 | 22 |
| Week 4 ACR20 | 157 |
| Week 4 ACR50 | 74 |
| Week 4 ACR70 | 30 |
| Week 8 ACR20 | 154 |
| Week 8 ACR50 | 74 |
| Week 8 ACR70 | 40 |
| Week 12 ACR20 | 154 |
| Week 12 ACR50 | 83 |
| Week 12 ACR70 | 39 |
| Week 16 ACR20 | 148 |
| Week 16 ACR50 | 81 |
| Week 16 ACR70 | 46 |
| Week 20 ACR20 | 155 |
| Week 20 ACR50 | 77 |
| Week 20 ACR70 | 46 |
| Week 24 ACR20 | 155 |
| Week 24 ACR50 | 91 |
| Week 24 ACR70 | 46 |
| Week 36 ACR20 | 163 |
| Week 36 ACR50 | 99 |
| Week 36 ACR70 | 50 |
| Week 48 ACR20 | 158 |
| Week 48 ACR50 | 99 |
| Week 48 ACR70 | 52 |
| Week 60 ACR20 | 141 |
| Week 60 ACR50 | 86 |
| Week 60 ACR70 | 47 |
| Week 72 ACR20 | 118 |
| Week 72 ACR50 | 75 |
| Week 72 ACR70 | 45 |
| Week 84 ACR20 | 92 |
| Week 84 ACR50 | 63 |
| Week 84 ACR70 | 33 |
| Week 96 ACR20 | 81 |
| Week 96 ACR50 | 49 |
| Week 96 ACR70 | 24 |
| Week 108 ACR20 | 72 |
| Week 108 ACR50 | 43 |
| Week 108 ACR70 | 27 |
| Week 120 ACR20 | 63 |
| Week 120 ACR50 | 41 |
| Week 120 ACR70 | 23 |
| Week 132 ACR20 | 68 |
| Week 132 ACR50 | 49 |
| Week 132 ACR70 | 27 |
| Week 144 ACR20 | 63 |
| Week 144 ACR50 | 47 |
| Week 144 ACR70 | 25 |
| Week 156 ACR20 | 61 |
| Week 156 ACR50 | 47 |
| Week 156 ACR70 | 27 |
| Week 168 ACR20 | 62 |
| Week 168 ACR50 | 42 |
| Week 168 ACR70 | 28 |
| Week 180 ACR20 | 47 |
| Week 180 ACR50 | 33 |
| Week 180 ACR70 | 16 |
| Week 192 ACR20 | 24 |
| Week 192 ACR50 | 16 |
| Week 192 ACR70 | 8 |
| Week 204 ACR20 | 8 |
| Week 204 ACR50 | 7 |
| Week 204 ACR70 | 4 |
| Week 216 ACR20 | 1 |
| Week 216 ACR50 | 1 |
| Week 216 ACR70 | 0 |
| Final Value ACR20 | 166 |
| Final Value ACR50 | 104 |
| Final Value ACR70 | 58 |
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.
| TJC | Adalimumab 40 mg Eow |
|---|---|
| TJC Baseline (n=309) | 22.3 ± 11.59 |
| TJC Week 0 (n=309) | -7.2 ± 10.10 |
| TJC Week 4 (n=307) | -10.0 ± 10.10 |
| TJC Week 8 (n=304) | -10.6 ± 10.37 |
| TJC Week 12 (n=298) | -11.0 ± 10.70 |
| TJC Week 16 (n=287) | -11.5 ± 10.88 |
| TJC Week 20 (n=271) | -12.3 ± 10.84 |
| TJC Week 24 (n=261) | -13.3 ± 10.72 |
| TJC Week 36 (n=245) | -14.3 ± 10.43 |
| TJC Week 48(n=232) | -14.9 ± 10.88 |
| TJC Week 60 (n=209) | -15.4 ± 10.75 |
| TJC Week 72 (n=162) | -15.9 ± 10.86 |
| TJC Week 84 (n=125) | -16.0 ± 10.27 |
| TJC Week 96 (n=102) | -16.0 ± 9.74 |
| TJC Week 108 (n=95) | -16.0 ± 9.49 |
| TJC Week 120 (n=91) | -15.9 ± 9.42 |
| TJC Week 132 (n=90) | -16.1 ± 10.00 |
| TJC Week 144 (n=87) | -16.4 ± 10.15 |
| TJC Week 156(n=82) | -16.2 ± 11.63 |
| TJC Week 168 (n=78) | -17.7 ± 10.43 |
| TJC Week 180 (n=59) | -17.7 ± 11.39 |
| TJC Week 192 (n=33) | -17.8 ± 11.75 |
| TJC Week 204 (n=9) | -22.4 ± 8.50 |
| TJC Week 216 (n=1) | -24.0 ± 0 |
| TJC Final Value (n=309) | -12.5 ± 12.36 |
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.
| SJC | Adalimumab 40 mg Eow |
|---|---|
| Baseline (n=309) | 17.6 ± 8.26 |
| Week 0 (n=309) | -6.1 ± 7.69 |
| Week 4 (n=307) | -8.5 ± 7.72 |
| Week 8 (n=304) | -8.6 ± 8.31 |
| Week 12 (n=298) | -9.0 ± 8.09 |
| Week 16 (n=287) | -9.0 ± 8.08 |
| Week 20 (n=271) | -10.1 ± 7.88 |
| Week 24 (n=261) | -10.9 ± 7.91 |
| Week 36 (n=245) | -11.7 ± 7.83 |
| Week 48 (n=232) | -11.9 ± 8.20 |
| Week 60 (n=209) | -12.2 ± 8.50 |
| Week 72 (n=162) | -12.8 ± 8.20 |
| Week 84 (n=125) | -13.7 ± 7.73 |
| Week 96 (n=102) | -13.6 ± 7.50 |
| Week 108 (n=95) | -13.5 ± 7.68 |
| Week 120 (n=91) | -13.8 ± 7.75 |
| Week 132 (n=90) | -13.8 ± 8.17 |
| Week 144 (n=87) | -14.3 ± 7.44 |
| Week 156 (n=82) | -14.0 ± 7.76 |
| Week 168 (n=72) | -14.7 ± 7.89 |
| Week 180 (n=59) | -15.3 ± 7.76 |
| Week 192 (n=33) | -17.5 ± 8.30 |
| Week 204 (n=9) | -20.0 ± 4.97 |
| Week 216 (n=1) | -86.0 ± 0 |
| Final Value (n=309) | -10.6 ± 8.93 |
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.
| mm on a scale | Adalimumab 40 mg Eow |
|---|---|
| Baseline (n=309) | 67.2 ± 19.67 |
| Week 0 (n=309) | -20.0 ± 25.83 |
| Week 4 (n=307) | -27.9 ± 25.80 |
| Week 8 (n=304) | -28.1 ± 26.69 |
| Week 12 (n=298) | -28.3 ± 26.54 |
| Week 16 (n=286) | -29.9 ± 26.26 |
| Week 20 (n=271) | -33.1 ± 25.59 |
| Week 24 (n=261) | -35.1 ± 25.85 |
| Week 36 (n=245) | -37.3 ± 24.76 |
| Week 48 (n=232) | -37.8 ± 25.08 |
| Week 60 (n=209) | -38.1 ± 25.75 |
| Week 72 (n=162) | -39.6 ± 24.97 |
| Week 84 (n=125) | -43.1 ± 23.43 |
| Week 96 (n=102) | -42.8 ± 22.35 |
| Week 108 (n=94) | -43.6 ± 23.47 |
| Week 120 (n=91) | -42.2 ± 24.68 |
| Week 132 (n=90) | -42.9 ± 24.79 |
| Week 144 (n=87) | -42.3 ± 23.80 |
| Week 156 (n=82) | -44.3 ± 23.73 |
| Week 168 (n=78) | -45.6 ± 23.23 |
| Week 180 (n=59) | -45.0 ± 26.12 |
| Week 192 (n=33) | -46.1 ± 26.10 |
| Week 204 (n=9) | -60.1 ± 15.52 |
| Week 216 (n=1) | -64.0 ± 0 |
| Final Value (n=309) | -30.2 ± 30.04 |
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.
| mm on unit scale | Adalimumab 40 mg Eow |
|---|---|
| Baseline (n=309) | 63.5 ± 24.00 |
| Week 0 (n=309) | -14.2 ± 26.93 |
| Week 4 (n=307) | -19.4 ± 28.30 |
| Week 8 (n=304) | -19.8 ± 28.22 |
| Week 12 (n=298) | -21.1 ± 28.62 |
| Week 16 (n=287) | -21.0 ± 28.63 |
| Week 20 (n=271) | -23.0 ± 29.14 |
| Week 24 (n=261) | -23.9 ± 29.06 |
| Week 36 (n=244) | -26.9 ± 29.38 |
| Week 48 (n=231) | -27.3 ± 28.77 |
| Week 60 (n=209) | -28.2 ± 29.86 |
| Week 72 (n=162) | -29.4 ± 27.90 |
| Week 84 (n=125) | -30.4 ± 29.49 |
| Week 96 (n=102) | -31.7 ± 25.73 |
| Week 108 (n=95) | -28.0 ± 27.73 |
| Week 120 (n=90) | -27.9 ± 26.64 |
| Week 132 (n=90) | -29.2 ± 27.73 |
| Week 144 (n=87) | -28.6 ± 29.54 |
| Week 156 (n=82) | -29.7 ± 28.72 |
| Week 168 (n=78) | -29.7 ± 30.14 |
| Week 180 (n=59) | -30.1 ± 30.45 |
| Week 192 (n=33) | -22.3 ± 32.92 |
| Week 204 (n=8) | -48.1 ± 30.98 |
| Week 216 (n=1) | -85.0 ± 0 |
| Final Value (n=309) | -20.7 ± 31.77 |
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.
| mm on unit scale | Adalimumab 40 mg Eow |
|---|---|
| Baseline (n=309) | 61.3 ± 24.03 |
| Week 0 (n=309) | -12.3 ± 27.64 |
| Week 4 (n=307) | -17.0 ± 28.65 |
| Week 8 (n=304) | -17.7 ± 27.78 |
| Week 12 (n=298) | -19.1 ± 27.66 |
| Week 16 (n=287) | -19.6 ± 27.42 |
| Week 20 (n=271) | -22.2 ± 27.87 |
| Week 24 (n=261) | -22.7 ± 27.00 |
| Week 36 (n=244) | -26.0 ± 27.55 |
| Week 48 (n=231) | -26.5 ± 28.11 |
| Week 60 (n=209) | -27.1 ± 28.53 |
| Week 72 (n=162) | -28.6 ± 26.56 |
| Week 84 (n=125) | -28.1 ± 28.65 |
| Week 96 (n=102) | -30.0 ± 24.27 |
| Week 108 (n=95) | -28.6 ± 24.40 |
| Week 120 (n=90) | -26.3 ± 25.26 |
| Week 132 (n=90) | -28.5 ± 27.13 |
| Week 144 (n=87) | -27.6 ± 27.98 |
| Week 156 (n=82) | -29.7 ± 26.65 |
| Week 168 (n=78) | -29.4 ± 27.62 |
| Week 180 (n=59) | -29.9 ± 25.63 |
| Week 192 (n=33) | -23.5 ± 29.13 |
| Week 204 (n=9) | -39.7 ± 30.54 |
| Week 216 (n=1) | -86.0 ± 0 |
| Final Value (n=309) | -20.1 ± 31.24 |
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
| mm on a scale | Adalimumab 40 mg Eow |
|---|---|
| Baseline (n=309) | 1.5 ± 0.75 |
| Week 0 (n=309) | -0.2 ± 0.49 |
| Week 4 (n=307) | -0.3 ± 0.53 |
| Week 8 (n=304) | -0.3 ± 0.51 |
| Week 12 (n=298) | -0.3 ± 0.53 |
| Week 16 (n=287) | -0.3 ± 0.54 |
| Week 20 (n=271) | -0.3 ± 0.56 |
| Week 24 (n=261) | -0.4 ± 0.53 |
| Week 36 (n=244) | -0.4 ± 0.58 |
| Week 48 (n=231) | -0.4 ± 0.56 |
| Week 60 (n=209) | -0.5 ± 0.57 |
| Week 72 (n=162) | -0.5 ± 0.52 |
| Week 84 (n=125) | -0.5 ± 0.59 |
| Week 96 (n=102) | -0.5 ± 0.58 |
| Week 108 (n=95) | -0.5 ± 0.55 |
| Week 120 (n=90) | -0.4 ± 0.62 |
| Week 132 (n=90) | -0.5 ± 0.58 |
| Week 144 (n=87) | -0.5 ± 0.57 |
| Week 156 (n=82) | -0.5 ± 0.58 |
| Week 168 (n=78) | -0.6 ± 0.56 |
| Week 180 (n=59) | -0.5 ± 0.59 |
| Week 192 (n=33) | -0.5 ± 0.55 |
| Week 204 (n=9) | -0.7 ± 0.48 |
| Week 216 (n=1) | -1.4 ± 0 |
| Final Visit (n=309) | -0.3 ± 0.62 |
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.
| mg/dL | Adalimumab 40 mg Eow |
|---|---|
| Baseline (n=-309) | 4.7 ± 3.30 |
| Week 0 (n=309) | -1.2 ± 3.02 |
| Week 4 (n=307) | -1.7 ± 3.38 |
| Week 8 (n=303) | -1.6 ± 3.69 |
| Week 12 (n=298) | -1.5 ± 3.33 |
| Week 16 (n=287) | -1.6 ± 3.58 |
| Week 20 (n=271) | -1.8 ± 3.60 |
| Week 24 (n=261) | -1.9 ± 3.51 |
| Week 36 (n=245) | -2.2 ± 3.55 |
| Week 48 (n=231) | -2.3 ± 3.66 |
| Week 60 (n=209) | -2.5 ± 3.46 |
| Week 72 (n=162) | -2.4 ± 3.77 |
| Week 84 (n=125) | -2.9 ± 3.90 |
| Week 96 (n=102) | -3.3 ± 3.59 |
| Week 108 (n=95) | -3.1 ± 3.63 |
| Week 120 (n=91) | -2.7 ± 4.02 |
| Week 132 (n=90) | -3.3 ± 3.45 |
| Week 144 (n=87) | -3.3 ± 3.37 |
| Week 156 (n=82) | -3.5 ± 3.57 |
| Week 168 (n=78) | -3.4 ± 3.89 |
| Week 180 (n=58) | -3.2 ± 4.55 |
| Week 192 (n=33) | -4.2 ± 4.21 |
| Week 204 (n=9) | -5.4 ± 6.38 |
| Week 216 (n=1) | -4.0 ± 0 |
| Final Value (n=309) | -1.7 ± 4.01 |
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.
| participants | Adalimumab 40 mg Eow |
|---|---|
| Week 0 | 182 |
| Week 4 | 173 |
| Week 8 | 168 |
| Week 12 | 167 |
| Week 16 | 154 |
| Week 20 | 148 |
| Week 24 | 138 |
| Week 36 | 106 |
| Week 48 | 93 |
| Week 60 | 91 |
| Week 72 | 68 |
| Week 84 | 47 |
| Week 96 | 39 |
| Week 108 | 29 |
| Week 120 | 29 |
| Week 132 | 29 |
| Week 144 | 32 |
| Week 156 | 20 |
| Week 168 | 19 |
| Week 180 | 16 |
| Week 192 | 11 |
| Week 204 | 1 |
| Week 216 | 0 |
| Final Value | 141 |
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.
| minutes | Adalimumab 40 mg Eow |
|---|---|
| Baseline (n=246) | 221.8 ± 374.72 |
| Week 0 (n=182) | -48.9 ± 292.93 |
| Week 4 (n=173) | -64.2 ± 307.03 |
| Week 8 (n=168) | -69.4 ± 387.21 |
| Week 12 (n=167) | -79.7 ± 348.20 |
| Week 16 (n=154) | -64.0 ± 338.37 |
| Week 20 (n=148) | -87.9 ± 318.04 |
| Week 24 (n=138) | -104.9 ± 293.66 |
| Week 36 (n=106) | -79.9 ± 287.89 |
| Week 48 (n=93) | -86.5 ± 281.83 |
| Week 60 (n=91) | -95.0 ± 363.90 |
| Week 72 (n=68) | -86.4 ± 247.30 |
| Week 84 (n=47) | -30.5 ± 145.23 |
| Week 96 (n=39) | -95.6 ± 248.27 |
| Week 108 (n=29) | -97.4 ± 263.44 |
| Week 120 (n=29) | -94.8 ± 278.36 |
| Week 132 (n=29) | -116.9 ± 279.96 |
| Week 144 (n=32) | -34.2 ± 372.50 |
| Week 156 (n=20) | -46.3 ± 169.08 |
| Week 168 (n=19) | -138.0 ± 338.26 |
| Week 180 (n=16) | -98.8 ± 139.98 |
| Week 192 (n=11) | -47.7 ± 113.65 |
| Week 204 (n=1) | 30.0 ± 0 |
| Final Value (n=238) | -57.9 ± 358.24 |
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.
| participants | Adalimumab 40 mg Eow |
|---|---|
| Week 24 | 248 |
| Week 48 | 191 |
| Week 72 | 142 |
| Week 96 | 92 |
| Week 120 | 69 |
| Week 144 | 66 |
| Week 168 | 60 |
| Week 192 | 31 |
| Week 216 | 1 |
| Final Value | 250 |
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.
| IU/mL | Adalimumab 40 mg Eow |
|---|---|
| Baseline (n=308) | 293.7 ± 412.95 |
| Week 24 (n=308) | -37.6 ± 303.19 |
| Week 48 (n=243) | -82.1 ± 322.10 |
| Week 72 (n=185) | -104.2 ± 286.58 |
| Week 96 (n=112) | -59.7 ± 445.83 |
| Week 120 (n=93) | -101.0 ± 344.41 |
| Week 144 (n=88) | -111.1 ± 374.58 |
| Week 168 (n=80) | -139.1 ± 357.30 |
| Week 192 (n=41) | -143.0 ± 428.18 |
| Week 216 (n=4) | -76.0 ± 128.47 |
| Fina Value (n=308) | -55.9 ± 338.06 |
Collected over 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. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adalimumab 40 mg Eow | — | 111/309 (35.9%) | 285/309 (92.2%) |
| Event | Adalimumab 40 mg Eow |
|---|---|
| Rheumatoid arthritisMusculoskeletal and connective tissue disorders | 25/309 |
| Joint destructionMusculoskeletal and connective tissue disorders | 12/309 |
| PneumoniaInfections and infestations | 7/309 |
| Spinal compression fractureInjury, poisoning and procedural complications | 5/309 |
| BronchitisInfections and infestations | 4/309 |
| CellulitisInfections and infestations | 4/309 |
| Herpes zosterInfections and infestations | 4/309 |
| Synovial cystMusculoskeletal and connective tissue disorders | 4/309 |
| Tendon ruptureInjury, poisoning and procedural complications | 4/309 |
| Cerebral hemorrhageNervous system disorders | 3/309 |
| Event | Adalimumab 40 mg Eow |
|---|---|
| NasopharyngitisInfections and infestations | 139/309 |
| Adverse drug reactionGeneral disorders | 73/309 |
| DNA antibody positiveInvestigations | 50/309 |
| ConstipationGastrointestinal disorders | 42/309 |
| InsomniaPsychiatric disorders | 39/309 |
| RashSkin and subcutaneous tissue disorders | 39/309 |
| Antinuclear antibody positiveInvestigations | 38/309 |
| ContusionInjury, poisoning and procedural complications | 38/309 |
| BronchitisInfections and infestations | 37/309 |
| PruritusSkin and subcutaneous tissue disorders | 37/309 |
| Age, Customized(participants) | Adalimumab 40 mg Eow |
|---|---|
| < 40 years | 35 |
| Between 40 and 49 years | 57 |
| Between 50 and 59 years | 111 |
| >/= 60 years | 106 |
| Sex: Female, Male(Participants) | Adalimumab 40 mg Eow |
|---|---|
| Female | 249 |
| Male | 60 |
| Region of Enrollment(participants) | Adalimumab 40 mg Eow |
|---|---|
| Japan | 309 |
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