At a glance
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Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs and Monotherapy Who Have an Inadequate Response to Current Non-Biologic or Biologic DMARDs
In Brief
A Phase 3 clinical trial evaluating tocilizumab [RoActemra/Actemra] and Nonbiologic DMARDs of investigator's choice for Rheumatoid Arthritis. Completed, enrolled 886 participants across 227 sites.
Detailed Summary
This 3 arm randomized open label study will evaluate the safety, tolerability and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis, who have had inadequate response to or are unable to tolerate DMARDs. The protocol incorporates risk mitigation strategies developed in partnership with the FDA to manage known and potential risks associated with the treatment of tocilizumab. Patients will be randomized to receive tocilizumab either 4 mg/kg intravenous (iv) or 8 mg/kg iv with concomitant non-biologic DMARDs, or 8 mg/kg iv without concomitant non-biologic DMARDs, every 4 weeks, for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is 500-1000 individuals.
Study Details
Timeline
Interventions
8 mg/kg intravenous every 4 weeks for 24 weeks
4 mg/kg every 4 weeks for 24 weeks
Nonbiologic disease-modifying antirheumatic drugs (DMARDs) As prescribed