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: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Antirheumatic Agents

Criteria

Inclusion Criteria:

• Adult patients, ≥18 years of age

• Active rheumatoid arthritis of >6 months duration

• Received permitted DMARDs each at a stable dose for at least 7 weeks prior to baseline

Exclusion Criteria:

• Rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis

• Major surgery within 8 weeks prior to screening or planned within 6 months following randomization

• Unsuccessful treatment with a biologic agent, including an anti-TNF agent

• Previous treatment with tocilizumab