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.



We found this trial at
10
sites
Coeur D'Alene, Idaho
941
mi
from 91732
Coeur D'Alene, ID
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Atlanta, Georgia
1919
mi
from 91732
Atlanta, GA
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Austin, Texas
1212
mi
from 91732
Austin, TX
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Celebration, Florida
2179
mi
from 91732
Celebration, FL
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Charlotte, North Carolina
2102
mi
from 91732
Charlotte, NC
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Chevy Chase, Maryland 20815
2278
mi
from 91732
Chevy Chase, MD
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Detroit, Michigan
1966
mi
from 91732
Detroit, MI
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Kansas City, Kansas
1339
mi
from 91732
Kansas City, KS
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Philadelphia, Pennsylvania
2375
mi
from 91732
Philadelphia, PA
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Santa Clara, California 95051
317
mi
from 91732
Santa Clara, CA
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