Phase 3
Completed N=619
Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.
Source: ClinicalTrials.gov NCT00195702 ↗Enrolled (actual)
619
Serious AEs
30.0%
Results posted
Mar 2010
Primary outcomePrimary: Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 24 — 129; 131; 59 Participants — p=<0.001
Summary
The purpose of the study was to assess the safety, immunogenicity, and clinical efficacy of adalimumab compared with placebo (during double-blind phase) and to to evaluate the long-term safety and maintenance of efficacy following repeated administration of adalimumab (during open-label extension phase) in patients with persistently active rheumatoid arthritis who were receiving concurrent methotrexate therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 24 |
129; 131; 59 | <0.001 sig |
| PRIMARY Change From Baseline in Modified Total Sharp X-ray Score at Week 52 |
0.8; 0.1; 2.7 | <0.001 sig |
| PRIMARY Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 52 |
-0.61; -0.59; -0.25 | <0.001 sig |
| SECONDARY Number of Participants Meeting ACR20 Response Criteria at Week 52 |
116; 122; 48 | <0.001 sig |
| SECONDARY Change From Baseline in Modified Total Sharp X-ray Score at Week 24 |
0.6; 0.3; 1.3 | <0.01 sig |
| SECONDARY Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 24 |
-0.60; -0.56; -0.24 | <0.001 sig |
| SECONDARY Maintenance of the Disability Index of the HAQ at Week 52 for Participants Who Were Responders at Week 12 or Week 24 |
130; 121; 73; 7; 4; 9 | <0.001 sig |
| SECONDARY Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24 |
99; 111; 32; 21; 12; 23 | — |
| SECONDARY Number of Participants With a Continuous ACR70 Response for 6 Months During 52 Weeks of Treatment |
20; 18; 3 | <0.001 sig |
| SECONDARY Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point |
25; 29; 81; 69; 53; 26 | — |
| SECONDARY Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point |
71; 69; 135; 18; 13; 4 | — |
| SECONDARY Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point |
126; 120; 177; 5; 5; 2 | — |
| SECONDARY Estimated Yearly Progression of Rheumatoid Arthritis |
11.11; 9.46; 9.97; 0.77; 0.09; 2.66 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Age 18 or older and in good health (Investigator discretion) with a recent stable medical history
- Met American College of Rheumatology (ACR) criteria for diagnosis of active rheumatoid arthritis (RA) and had at both screening and baseline visits >=6 swollen joints and >=9 tender joints, despite a minimum of 3-months treatment with methotrexate (MTX). (Distal interphalangeal joints [DIPs] were not to be included in joint count for inclusion. The screening and baseline visits could be 3 to 28 days apart for patients not previously receiving disease-modifying anti-rheumatic drugs [DMARDs] other than MTX or 4 to 6 weeks for patients requiring a DMARD washout period.)
- Insufficient efficacy with MTX 12.5 to 25 mg per week (10 mg per week if MTX intolerant).
- If patient on a second-line treatment (DMARD) other than MTX, he/she had to discontinue it for at least 28 days before the baseline visit (the washout period).
- Treatment with oral folic acid 1-3 mg/day or, if appropriate, up to 10 mg leucovorin per week.
- Both rheumatoid factor positivity and a C-reactive protein value >=1 mg/dL, or at least one joint erosion on X-ray.
Exclusion Criteria
- Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study.
- Female subject who was pregnant or breast-feeding or considering becoming pregnant.
- Preceding treatment with any tumor necrosis factor (TNF) antagonist, including adalimumab.
- Prior exposure to alkylating agents, such as chlorambucil or cyclophosphamide.
- Intra-articular, intramuscular, or intravenous administration of corticosteroids within 4 weeks prior to the screening visit.
- Subject was wheelchair bound or bedridden.
Data sourced from ClinicalTrials.gov (NCT00195702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.