A Phase 3 interventional study of Adalimumab in Rheumatoid Arthritis, sponsored by Abbott. Completed at 16 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2011-06-21.
Sponsored by Abbott · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the long-term safety of subcutaneous (SC) self-injections (by the subject or subject's family member) of adalimumab in adult Japanese subjects with Rheumatoid Arthritis in an open-label study.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 88 is close to 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:
Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 \[NCT 00235872\]) subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
Biological: Adalimumab
40 mg or 80 mg every other week (eow), subcutaneous (sc), self-injection
Also known as: Humira, ABT-D2E7
Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively)
Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: \[1\] physician's global assessment of disease activity (PGA), \[2\] subject's assessment of disease activity, \[3\] subject's assessment of pain, \[4\] subject's assessment of physical disability via a health assessment questionnaire disability index(HAQ-DI), and \[5\] C-reactive protein (CRP) at each visit.
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 ACR Criteria, by Visit
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in TJC (max = 68), a component of the ACR criteria, by visit
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 ACR Criteria by Visit
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in SJC (max = 66), a component of the ACR criteria, by visit
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's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit
Time frame: Every 4 weeks 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 (0 - 100 mm With 100 mm Being the Worst Assessment), a Component of the ACR Criteria, by Visit
mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in subjects global assessment of disease activity (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit
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 (0 - 100 mm With 100 mm Being the Worst Pain), a Component of the ACR Criteria, by Visit
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in subject's assessment of pain (on a visual analog scale from 0 - 100 mm with 100 mm being the worst pain), a component of the ACR criteria, by visit
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 Disability Index of the Health Assessment Questionnaire (HAQ), a Component of the ACR Criteria, by Visit
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in disability index of the HAQ (includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a scale from 0 - 3 to measure the ability to perform certain activities \[0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so\]), a component of the ACR criteria by visit
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 ACR Criteria by Visit
Mean change from baseline(for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in CRP (mg/dL), a component of the ACR criteria, by visit
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 by Visit
The number of subjects with morning stiffness at each visit among those who had morning stiffness at baseline (64).
Time frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until study completion or discontinuation (final value)
Duration (Minutes) of the Presence of Morning Stiffness by Visit
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in the duration (minutes) of stiffness in the morning.
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 or 80 mg Every Other Week (Eow) |
|---|---|
| Started | 88 |
| Completed | 68 |
| Not completed | 20 |
Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: \[1\] physician's global assessment of disease activity (PGA), \[2\] subject's assessment of disease activity, \[3\] subject's assessment of pain, \[4\] subject's assessment of physical disability via a health assessment questionnaire disability index(HAQ-DI), and \[5\] C-reactive protein (CRP) at each visit.
| participants | Adalimumab 40 mg or 80 mg Every Other Week (Eow) |
|---|---|
| Week 0 ACR20 | 66 |
| Week 0 ACR50 | 48 |
| Week 0 ACR70 | 28 |
| Week 4 ACR20 | 64 |
| Week 4 ACR50 | 44 |
| Week 4 ACR70 | 27 |
| Week 8 ACR20 | 69 |
| Week 8 ACR50 | 45 |
| Week 8 ACR70 | 32 |
| Week 12 ACR20 | 68 |
| Week 12 ACR50 | 50 |
| Week 12 ACR70 | 30 |
| Week 16 ACR20 | 67 |
| Week 16 ACR50 | 49 |
| Week 16 ACR70 | 30 |
| Week 20 ACR20 | 68 |
| Week 20 ACR50 | 49 |
| Week 20 ACR70 | 31 |
| Week 24 ACR20 | 63 |
| Week 24 ACR50 | 48 |
| Week 24 ACR70 | 29 |
| Week 36 ACR20 | 64 |
| Week 36 ACR50 | 45 |
| Week 36 ACR70 | 32 |
| Week 48 ACR20 | 62 |
| Week 48 ACR50 | 46 |
| Week 48 ACR70 | 27 |
| Week 60 ACR20 | 56 |
| Week 60 ACR50 | 44 |
| Week 60 ACR70 | 28 |
| Week 72 ACR20 | 57 |
| Week 72 ACR50 | 47 |
| Week 72 ACR70 | 32 |
| Week 84 ACR20 | 57 |
| Week 84 ACR50 | 42 |
| Week 84 ACR70 | 29 |
| Week 96 ACR20 | 56 |
| Week 96 ACR50 | 43 |
| Week 96 ACR70 | 27 |
| Week 108 ACR20 | 54 |
| Week 108 ACR50 | 45 |
| Week 108 ACR70 | 29 |
| Week 120 ACR20 | 28 |
| Week 120 ACR50 | 24 |
| Week 120 ACR70 | 16 |
| Week 132 ACR20 | 7 |
| Week 132 ACR50 | 3 |
| Week 132 ACR70 | 3 |
| Final Value ACR20 | 62 |
| Final Value ACR50 | 49 |
| Final Value ACR70 | 35 |
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in TJC (max = 68), a component of the ACR criteria, by visit
| TJC | Adalimumab 40 mg or 80 mg Every Other Week (Eow) |
|---|---|
| Baseline | 20.5 ± 12.1 |
| Week 0 | -15.3 ± 11.3 |
| Week 4 | -14.9 ± 11.4 |
| Week 8 | -15.3 ± 11.1 |
| Week 12 | -14.8 ± 10.7 |
| Week 16 | -14.7 ± 10.8 |
| Week 20 | -15.2 ± 10.6 |
| Week 24 | -15.5 ± 10.9 |
| Week 36 | -14.9 ± 10.9 |
| Week 48 | -15.0 ± 11.5 |
| Week 60 | -15.4 ± 11.4 |
| Week 72 | -15.7 ± 11.5 |
| Week 84 | -16.1 ± 11.3 |
| Week 96 | -16.8 ± 11.8 |
| Week 108 | -16.5 ± 11.6 |
| Week 120 | -18.1 ± 12.4 |
| Week 132 | -19.4 ± 9.5 |
| Final | -14.9 ± 12.1 |
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in SJC (max = 66), a component of the ACR criteria, by visit
| SJC | Adalimumab 40 mg or 80 mg Every Other Week (Eow) |
|---|---|
| Baseline | 15.8 ± 8.6 |
| Week 0 | -11.9 ± 8.3 |
| Week 4 | -11.9 ± 8.3 |
| Week 8 | -12.3 ± 8.0 |
| Week 12 | -11.9 ± 7.7 |
| Week 16 | -12.1 ± 7.8 |
| Week 20 | -11.9 ± 8.3 |
| Week 24 | -11.9 ± 8.3 |
| Week 36 | -11.6 ± 8.3 |
| Week 48 | -11.5 ± 8.8 |
| Week 60 | -11.5 ± 8.4 |
| Week 72 | -12.2 ± 7.8 |
| Week 84 | -12.3 ± 7.8 |
| Week 96 | -12.0 ± 7.8 |
| Week 108 | -12.0 ± 8.2 |
| Week 120 | -12.5 ± 8.7 |
| Week 132 | -12.9 ± 8.0 |
| Final | -11.6 ± 8.0 |
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in PGA (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit
| mm on a scale | Adalimumab 40 mg or 80 mg Every Other Week (Eow) |
|---|---|
| Baseline | 63.2 ± 21.8 |
| Week 0 | -41.0 ± 26.2 |
| Week 4 | -39.5 ± 27.0 |
| Week 8 | -43.3 ± 23.2 |
| Week 12 | -41.6 ± 24.9 |
| Week 16 | -42.1 ± 25.5 |
| Week 20 | -44.0 ± 24.6 |
| Week 24 | -42.3 ± 26.2 |
| Week 36 | -42.2 ± 25.8 |
| Week 48 | -41.4 ± 27.9 |
| Week 60 | -40.7 ± 28.3 |
| Week 72 | -42.2 ± 26.5 |
| Week 84 | -41.9 ± 26.2 |
| Week 96 | -44.6 ± 24.1 |
| Week 108 | -44.7 ± 25.9 |
| Week 120 | -48.8 ± 27.4 |
| Week 132 | -62.4 ± 10.7 |
| Final | -38.8 ± 31.9 |
mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in subjects global assessment of disease activity (a visual analog scale from 0 - 100 mm with 100 mm being the worst case), a component of the ACR criteria, by visit
| mm on a scale | Adalimumab 40 mg or 80 mg Every Other Week (Eow) |
|---|---|
| Baseline | 58.4 ± 26.8 |
| Week 0 | -34.0 ± 29.8 |
| Week 4 | -32.2 ± 31.1 |
| Week 8 | -33.4 ± 29.2 |
| Week 12 | -33.9 ± 29.3 |
| Week 16 | -33.2 ± 30.9 |
| Week 20 | -34.9 ± 30.4 |
| Week 24 | -33.1 ± 30.9 |
| Week 36 | -31.6 ± 34.6 |
| Week 48 | -33.3 ± 34.0 |
| Week 60 | -30.7 ± 33.6 |
| Week 72 | -33.9 ± 33.1 |
| Week 84 | -31.1 ± 32.2 |
| Week 96 | -31.7 ± 30.4 |
| Week 108 | -33.0 ± 34.0 |
| Week 120 | -37.9 ± 29.4 |
| Week 132 | -37.0 ± 31.7 |
| Final | -29.5 ± 35.7 |
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in subject's assessment of pain (on a visual analog scale from 0 - 100 mm with 100 mm being the worst pain), a component of the ACR criteria, by visit
| mm on a scale | Adalimumab 40 mg or 80 mg Every Other Week (Eow) |
|---|---|
| Baseline | 57.8 ± 27.1 |
| Week 0 | -33.6 ± 27.7 |
| Week 4 | -31.8 ± 29.6 |
| Week 8 | -33.7 ± 28.1 |
| Week 12 | -33.3 ± 27.7 |
| Week 16 | -32.5 ± 29.7 |
| Week 20 | -33.0 ± 29.9 |
| Week 24 | -34.0 ± 29.3 |
| Week 36 | -30.6 ± 33.3 |
| Week 48 | -32.1 ± 31.7 |
| Week 60 | -30.4 ± 32.8 |
| Week 72 | -33.4 ± 31.2 |
| Week 84 | -30.8 ± 31.3 |
| Week 96 | -32.0 ± 28.3 |
| Week 108 | -31.9 ± 32.1 |
| Week 120 | -33.5 ± 31.1 |
| Week 132 | -38.9 ± 27.1 |
| Final | -29.1 ± 35.8 |
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in disability index of the HAQ (includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a scale from 0 - 3 to measure the ability to perform certain activities \[0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so\]), a component of the ACR criteria by visit
| units on a scale | Adalimumab 40 mg or 80 mg Every Other Week (Eow) |
|---|---|
| Baseline | 1.4 ± 0.7 |
| Week 0 | -0.5 ± 0.5 |
| Week 4 | -0.5 ± 0.6 |
| Week 8 | -0.6 ± 0.6 |
| Week 12 | -0.6 ± 0.6 |
| Week 16 | -0.6 ± 0.6 |
| Week 20 | -0.6 ± 0.6 |
| Week 24 | -0.6 ± 0.6 |
| Week 36 | -0.5 ± 0.6 |
| Week 48 | -0.6 ± 0.6 |
| Week 60 | -0.5 ± 0.6 |
| Week 72 | -0.6 ± 0.6 |
| Week 84 | -0.5 ± 0.6 |
| Week 96 | -0.5 ± 0.6 |
| Week 108 | -0.6 ± 0.6 |
| Week 120 | -0.6 ± 0.6 |
| Week 132 | -0.7 ± 0.9 |
| Final | -0.5 ± 0.7 |
Mean change from baseline(for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in CRP (mg/dL), a component of the ACR criteria, by visit
| mg/dL | Adalimumab 40 mg or 80 mg Every Other Week (Eow) |
|---|---|
| Baseline | 4.0 ± 2.7 |
| Week 0 | -2.5 ± 2.9 |
| Week 4 | -2.4 ± 3.0 |
| Week 8 | -2.5 ± 2.9 |
| Week 12 | -2.6 ± 2.9 |
| Week 16 | -2.6 ± 2.8 |
| Week 20 | -2.8 ± 2.7 |
| Week 24 | -2.8 ± 2.8 |
| Week 36 | -2.8 ± 3.0 |
| Week 48 | -2.7 ± 3.0 |
| Week 60 | -2.3 ± 3.6 |
| Week 72 | -2.5 ± 3.1 |
| Week 84 | -2.7 ± 3.0 |
| Week 96 | -2.8 ± 2.3 |
| Week 108 | -2.9 ± 2.4 |
| Week 120 | -2.8 ± 2.3 |
| Week 132 | -2.9 ± 1.9 |
| Final | -2.2 ± 4.1 |
The number of subjects with morning stiffness at each visit among those who had morning stiffness at baseline (64).
| participants | Adalimumab 40 mg or 80 mg Every Other Week (Eow) |
|---|---|
| Week 0 | 24 |
| Week 4 | 29 |
| Week 8 | 26 |
| Week 12 | 25 |
| Week 16 | 24 |
| Week 20 | 23 |
| Week 24 | 23 |
| Week 36 | 22 |
| Week 48 | 19 |
| Week 60 | 23 |
| Week 72 | 20 |
| Week 84 | 21 |
| Week 96 | 15 |
| Week 108 | 15 |
| Week 120 | 7 |
| Week 132 | 1 |
| Final | 22 |
Mean change from baseline (for subjects without rescue treatment, baseline is from Study M02-575 \[NCT 00647491\]; for subjects with rescue treatment, baseline is from Study M03-651 \[NCT 00235872\]) in the duration (minutes) of stiffness in the morning.
| minutes | Adalimumab 40 mg or 80 mg Every Other Week (Eow) |
|---|---|
| Baseline | 164.7 ± 333.9 |
| Week 0 | -119.1 ± 273.0 |
| Week 4 | -98.5 ± 214.8 |
| Week 8 | -122.3 ± 271.8 |
| Week 12 | -100.3 ± 234.9 |
| Week 16 | -120.1 ± 273.3 |
| Week 20 | -123.2 ± 277.2 |
| Week 24 | -120.1 ± 277.8 |
| Week 36 | -104.8 ± 238.0 |
| Week 48 | -104.2 ± 243.7 |
| Week 60 | -95.7 ± 245.8 |
| Week 72 | -102.3 ± 250.4 |
| Week 84 | -103.9 ± 253.4 |
| Week 96 | -115.5 ± 256.2 |
| Week 108 | -120.2 ± 351.8 |
| Week 120 | -115.9 ± 257.3 |
| Week 132 | -75.0 ± 89.8 |
| Final | -97.9 ± 381.3 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adalimumab 40 mg or 80 mg Every Other Week (Eow) | — | 20/88 (22.7%) | 84/88 (95.5%) |
| Event | Adalimumab 40 mg or 80 mg Every Other Week (Eow) |
|---|---|
| Rheumatoid arthritisMusculoskeletal and connective tissue disorders | 4/88 |
| Joint destructionMusculoskeletal and connective tissue disorders | 3/88 |
| Urinary tract infectionInfections and infestations | 2/88 |
| Clavicle fractureInjury, poisoning and procedural complications | 2/88 |
| Angina pectorisCardiac disorders | 1/88 |
| Atrial thrombosisCardiac disorders | 1/88 |
| Cardiac failureCardiac disorders | 1/88 |
| Vertigo positionalEar and labyrinth disorders | 1/88 |
| CataractEye disorders | 1/88 |
| EnterocolitisGastrointestinal disorders | 1/88 |
| Event | Adalimumab 40 mg or 80 mg Every Other Week (Eow) |
|---|---|
| NasopharyngitisInfections and infestations | 53/88 |
| Adverse drug reactionGeneral disorders | 26/88 |
| Antinuclear antibody positiveInvestigations | 14/88 |
| ConstipationGastrointestinal disorders | 13/88 |
| BronchitisInfections and infestations | 12/88 |
| Dental cariesGastrointestinal disorders | 11/88 |
| ContusionInjury, poisoning and procedural complications | 11/88 |
| Upper respiratory tract infectionInfections and infestations | 9/88 |
| FallInjury, poisoning and procedural complications | 9/88 |
| DNA antibody positiveInvestigations | 9/88 |
| Age Continuous(years) | Adalimumab 40 mg or 80 mg Every Other Week (Eow) |
|---|---|
| Mean | 52.3 ± 11.0 |
| Sex: Female, Male(Participants) | Adalimumab 40 mg or 80 mg Every Other Week (Eow) |
|---|---|
| Female | 67 |
| Male | 21 |
| Region of Enrollment(participants) | Adalimumab 40 mg or 80 mg Every Other Week (Eow) |
|---|---|
| Japan | 88 |
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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