A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis
Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
Summary
This 2-arm study assessed the safety and efficacy of tocilizumab versus placebo, both in
combination with disease modifying antirheumatic drugs (DMARDs), in regard to reduction in
signs and symptoms, in patients with moderate to severe active rheumatoid arthritis with an
inadequate response to DMARDs. Patients were randomized in a ratio of 2:1 to receive either
tocilizumab 8 mg/kg intravenously (IV) or placebo IV every 4 weeks. All patients also
received stable antirheumatic therapy, including permitted DMARDs. The anticipated time on
study treatment was 3-12 months and the target sample size was 500+ individuals.