A Study to Assess the Effect of Tocilizumab on Signs and Symptoms in Patients With Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2010-02-13
• Target enrollment: 0
• Participant gender: All

Summary

This single arm, open label study will assess the safety and efficacy, with regard to reduction of signs and symptoms,of treatment with tocilizumab in patients with moderate to severe active rheumatoid arthritis. Patients will receive tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions. Patients already receiving methotrexate at entry into the study may continue with their treatment together with tocilizumab.The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

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

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• adult patients,>=18 years of age;

• rheumatoid arthritis diagnosed >8 weeks and <4 years prior to baseline;

• naive to, or not responding well to, methotrexate;

• swollen joint count >=8 (66 joint count) and tender joint count>=8 (68 joint count) at screening and baseline.

Exclusion Criteria:

• rheumatic autoimmune disease other than rheumatoid arthritis;

• patients with functional class IV rheumatoid arthritis;

• history of, or current, inflammatory joint disease other than rheumatoid arthritis, or other systemic autoimmune disorder.