Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
This was a 10-year study which had an initial 52-week, double-blind, placebo-controlled phase followed by an open-label extension phase up to 9 years in duration. Data were analyzed for the double-blind phase using all patients who were randomized and received at least one dose of study drug through Week 52 and for all patients who received at least one dose of adalimumab during the 10-year study (the Intent-to-Treat [ITT] population).
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
619 participants in 6 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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