A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous TNF Antagonist Therapy



Status:Archived
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:October 2010
End Date:October 2012

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A Randomized, Double-blind, Parallel Group Placebo-controlled Study of the Safety and Reduction of Signs and Symptoms During Treatment With Tocilizumab (TCZ) Versus Placebo in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous TNF Antagonist Therapy


This randomized, double-blind, placebo-controlled study will evaluate the safety and
efficacy of RoActemra/Actemra (tocilizumab) in patients with ankylosing spondylitis who have
had an inadequate response to previous TNF antagonist therapy. Patients will be randomized
to receive RoActemra/Actemra at a dose of either 8 mg/kg or 4mg/kg intravenously (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 104 for all
patients. Anticipated time on study treatment is 104 weeks.



We found this trial at
10
sites
Philadelphia, Pennsylvania
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Atlanta, Georgia
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Atlanta, GA
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Celebration, Florida
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Celebration, FL
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Charlotte, North Carolina
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Charlotte, NC
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Chevy Chase, Maryland 20815
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Chevy Chase, MD
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Coeur D'Alene, Idaho
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Coeur D'Alene, ID
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Detroit, Michigan
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Detroit, MI
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Kansas City, Kansas
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Kansas City, KS
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Santa Clara, California 95051
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Santa Clara, CA
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West Orange, New Jersey
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West Orange, NJ
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