At a glance
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An Open-label, Prospective, Multi-Centre Study to Assess the Safety and Efficacy of Adalimumab (Humira®) When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis
In Brief
A Phase 3 clinical trial evaluating adalimumab for Rheumatoid Arthritis. Completed, enrolled 100 participants across 5 sites.
Detailed Summary
A total of 100 participants diagnosed with active rheumatoid arthritis were enrolled at 5 sites in Russia. Adalimumab was administered by subcutaneous injection every other week, with dose escalation to weekly dosing available for participants not receiving concomitant disease-modifying antirheumatic drugs (DMARDs) who did not achieve American College of Rheumatology 20 (ACR20) criteria after 12 weeks of treatment. Efficacy and safety measurements were performed throughout the study.
Study Details
Timeline
Interventions
Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.