Spondylitis, Ankylosing Clinical Trial
Official title:
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 evaluated the safety and efficacy of
tocilizumab (RoActemra/Actemra) in patients with ankylosing spondylitis (AS) who had an
inadequate response to previous tumor necrosis factor (TNF) antagonist therapy. Patients
were randomized to receive tocilizumab at a dose of either 8 mg/kg or 4 mg/kg intravenously
(iv) or placebo every 4 weeks for 24 weeks. The double-blind treatment period was followed
by open-label treatment with tocilizumab 8 mg/kg iv every 4 weeks until Week 104 for all
patients.
This study and all further clinical development of tocilizumab AS was halted after a review
of 12-week data from Study NA22823, a randomized double-blind, placebo-controlled study in
TNF antagonist naïve AS patients, failed to demonstrate efficacy.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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