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 |
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
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