At a glance
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Comparative Double Blind Placebo Controlled Clinical Study on Tocilizumab Rapid Efficacy on Patients Relief in rheumatoïd Arthritis With an Inadequate Response to DMARDs or Anti TNF :TORPEDO
In Brief
A Phase 3 clinical trial evaluating tocilizumab [RoActemra/Actemra] and placebo for Rheumatoid Arthritis. Completed, enrolled 103 participants across 22 sites.
Detailed Summary
This study will assess the onset and maintenance of effect of tocilizumab on relief in patients with active moderate or severe rheumatoid arthritis who have had an inadequate response to DMARDs or anti-TNF. For the first, double-blind, part of the study patients will be randomized to receive an iv infusion of either 8mg/kg tocilizumab or placebo. After 4 weeks this will be followed by 11 months treatment with tocilizumab 8mg/kg iv infusion every 4 weeks. Methotrexate or DMARD therapy will be continued throughout study treatment. Target sample size is \>100.
Study Details
Timeline
Interventions
single iv infusion 8 mg/kg
single iv infusion
iv infusion 8mg/kg every 4 weeks for 11 months