At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled Study to Assess Efficacy of Tocilizumab+Non-biological DMARD in Reducing Synovitis as Measured by MRI at 12 Weeks After Initiation of Treatment in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Non-biological DMARDs
In Brief
A Phase 4 clinical trial evaluating tocilizumab [RoActemra/Actemra], placebo, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 54 participants across 11 sites.
Detailed Summary
This randomized, double-blind, placebo-controlled study will use Magnetic Resonance Imaging (MRI) to assess the efficacy of tocilizumab plus non-biological DMARD in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to non-biological DMARDS. Patients will be randomized to receive either intravenous tocilizumab at 8mg/kg (minimal dose 480mg, maximum dose 800mg) or placebo every 4 weeks, in addition to their stable dose of non-biological DMARD. Anticipated time on study treatment is 24 weeks, and target sample size is \<100.
Study Details
Timeline
Interventions
8mg/kg (minimal dose 480mg, maximum dose 800mg) iv infusion every 4 weeks for 24 weeks
iv every 4 weeks for 24 weeks
stable dose at investigator's prescription