A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDs



Status:Archived
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:September 2010
End Date:August 2014

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A Ph II/III Seamless, Multi-center, Randomized, Double-blind, Placebo-controlled Study of the Reduction in Signs and Symptoms and Inhibition of Structural Damage During Treatment With Tocilizumab Versus Placebo in Patients With Ankylosing Spondylitis Who Have Failed Non-steroidal Anti-inflammatory Drugs and Are naïve to TNF Antagonist Therapy NSAIDs


This randomized, double-blind, placebo-controlled study will evaluate the safety and
efficacy of RoActemra/Actemra (tocilizumab) in patients with ankylosing spondylitis who have
failed treatment with non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist
therapy. In Part 1 of the study, patients will be randomized to receive either
RoActemra/Actemra 8 mg/kg intravenously (iv) or placebo every 4 weeks for 12 weeks. In Part
2, patients will be randomized to receive RoActemra at either 8 mg/kg or 4 mg/kg iv or
placebo every 4 weeks for 24 weeks. The double-blind treatment period will be followed by
open-label treatment with RoActemra/Actemra 8 mg/kg iv every 4 weeks until Week 208 for all
patients. Anticipated time on study treatment is 208 weeks.



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Austin, Texas
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Atlanta, Georgia
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Chevy Chase, Maryland 20815
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Coeur D'Alene, Idaho
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Philadelphia, Pennsylvania
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Santa Clara, California 95051
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