A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.

• Status: Completed
• Trial end date: 2011-02-14
• Target enrollment: 0
• Participant gender: All

Summary

This open-label single arm study will evaluate the efficacy and safety of tocilizumab added to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis and an inadequate response to DMARDs. Patients will receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition to their current non-biologic DMARDs at stable doses. Anticipated time on study treatment is 24 weeks, and the target sample size is 200.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• adult patients, >/= 18 years of age

• moderate to severe active rheumatoid arthritis of >/=6 months duration

• inadequate clinical response to current non-biologic DMARDs

• current DMARDs must be at stable dose for 8 weeks prior to study entry

• oral corticosteroids (stable dose for >/=4 weeks prior to screening

Exclusion Criteria:

• rheumatic autoimmune disease other than RA

• history of or current inflammatory joint disease other than RA

• previous treatment with any biologic DMARD

• functional class IV as defined by the ACR classification

• intra-articular or parenteral corticosteroids within 6 weeks prior to screening