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

• Status: Completed
• Trial end date: 2010-07-22
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• adult patients, 18-70 years of age;

• rheumatoid arthritis for >= 6 months;

• receiving permitted DMARDs, at a stable dose, for >= 8 weeks prior to baseline;

• current inadequate clinical response to DMARDs.

Exclusion Criteria:

• major surgery, including joint surgery, within 8 weeks before entering study, or planned major surgery within 6 months following randomization;

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

• unsuccessful treatment with an anti-TNF agent;

• previous treatment with tocilizumab.