A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis.

Summary

This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with active rheumatoid arthritis who currently have an inadequate response to DMARD therapy. Patients will be randomized 2:1 to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Timeline

Start

2008-10-31

Primary completion

2010-07-22

Completion

2010-07-22

Outcome

Met primary endpoint

registry Placebo + DMARDs vs Tocilizumab + DMARDs; p <0.0001; Cochran-Mantel-Haenszel NCT00773461 ↗

Drugs

Indications