A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDs

• Status: Completed
• Trial end date: 2010-05-26
• Target enrollment: 0
• Participant gender: All

Summary

This single arm study will assess the safety and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to current non-biologic DMARDs. Patients will receive iv infusions of tocilizumab 8mg/kg every 4 weeks for a total of 6 infusions, either as monotherapy or in combination with their current non-biologic DMARDs.

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

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• adult patients, >=18 years of age;

• moderate to severe rheumatoid arthritis;

• inadequate response to current non-biologic DMARDs

Exclusion Criteria:

• rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;

• previous treatment with other biologics.