At a glance
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Local Open-label Multicenter Study to Evaluate the Quality of Life in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to DMARDs When Adding Tocilizumab (TCZ)
In Brief
A Phase 4 clinical trial evaluating tocilizumab [RoActemra/Actemra] and DMARDs (disease-modifying antirheumatic drugs) for Rheumatoid Arthritis. Completed, enrolled 201 participants across 28 sites.
Detailed 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.
Study Details
Timeline
Interventions
8 mg/kg iv every 4 weeks for 24 weeks
stable doses at investigator's prescription