Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Adalimumab; Methotrexate

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.