A Study of Tocilizumab in Combination With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Moderate to Severe Active Rheumatoid Arthritis With an Inadequate Response to DMARDs

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This open-label, single-arm study will evaluate the efficacy and safety of tocilizumab in combination with DMARDs in participants with moderate to severe active rheumatoid arthritis who have an inadequate response to DMARDs. Participants will receive tocilizumab as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 4 weeks in addition to their current DMARD therapy.

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

Details

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

Criteria

Inclusion Criteria:

• Moderate to severe active RA of ≥6 months duration

• DAS28 >3.2

• Inadequate response to a stable dose of non-biologic DMARD for ≥2 months

• Those receiving oral corticosteroids must have been at stable dose for ≥25 days in the 28 days prior to first study treatment

Exclusion Criteria:

• Rheumatic autoimmune disease other than RA

• History of or current inflammatory joint disease other than RA

• Previous treatment with alkylating agents or total lymphoid irradiation

• Intra-articular or parenteral corticosteroids within 6 weeks prior to Baseline

• Previous treatment with any cell-depleting therapies

• American College of Rheumatology (ACR) Functional Class IV