A Study of Tocilizumab + DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2011-07-22
• Target enrollment: 0
• Participant gender: All

Summary

This single arm study will assess the effect of tocilizumab + DMARDs (Disease Modifying Anti-Rheumatic Drugs)on improvement of anemia and fatigue in patients with moderate to severe active rheumatoid arthritis. Eligible patients who have had an inadequate response to DMARDs will receive tocilizumab 8mg/kg iv every 4 weeks in combination with standard DMARDs, for 6 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 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;

• rheumatoid arthritis >=6 months duration;

• DAS28>=3.2;

• inadequate response to prior treatment with a stable dose (>=8 weeks) of DMARD therapy.

Exclusion Criteria:

• rheumatic autoimmune disease other than rheumatoid arthritis;

• history of or current inflammatory joint disease other than rheumatoid arthritis;

• unsuccessful treatment with an anti-TNF agent;

• previous/concurrent treatment with any cell-depleting therapies.