At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years in good health with stable medical history
- ✓Meets ACR criteria for active RA with ≥6 swollen joints and ≥9 tender joints at screening and baseline despite ≥3 months methotrexate treatment
- ✓Insufficient efficacy with MTX at dose of 12.5–25 mg/week (or ≥10 mg/week if MTX-intolerant)
- ✓If on second-line DMARD other than MTX, must have discontinued it ≥28 days before baseline
- ✕Prior treatment with any TNF antagonist, including adalimumab
- ✕Prior exposure to alkylating agents such as chlorambucil or cyclophosphamide
- ✕Intra-articular, intramuscular, or intravenous corticosteroid administration within 4 weeks before screening
- ✕Wheelchair-bound or bedridden
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Rheumatoid Arthritis Patients Currently Receiving Treatment With Methotrexate
In Brief
A Phase 3 clinical trial evaluating Adalimumab and Placebo for Rheumatoid Arthritis. Completed, enrolled 619 participants across 87 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Self-administered, subcutaneous injection of 20 mg adalimumab (1.6 mL/injection) once weekly (ew) for up to 52 weeks.
Self-administered, subcutaneous injection of 40 mg adalimumab (1.6 mL/injection) every other week (eow) for up to 52 weeks.
Self-administered, subcutaneous injection of placebo (1.6 mL/injection) once weekly (ew) for up to 52 weeks.
Self-administration, subcutaneous (SC) injection of adalimumab 20 mg (1.6 mL/injection) once weekly (ew) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL/injection) every other week (eow) for up to Week 520.
Self-administration, subcutaneous (SC) injection of adalimumab 40 mg (1.6 mL/injection) every other week (eow) (with a placebo 1.6 mL/injection on alternate weeks) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL injection) eow for up to Week 520.
Self-administration, subcutaneous (SC) injection of placebo solution (1.6 mL/injection) once weekly (ew) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL/injection) every other week (eow) for up to Week 520.