Spondylitis, Ankylosing Clinical Trial
Official title:
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 (AS) who have failed treatment with non-steroidal anti-inflammatory drugs and are naïve to tumor necrsos factor (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.
This study was planned as a Phase II/III seamless, multicenter, randomized, double-blind,
placebo-controlled study in patients with AS who were naïve to TNF antagonist therapy. The
study consisted of 2 parts, each preceded by a screening visit and followed by a common
open-label extension phase. Recruitment into Part 2 commenced after completion of enrollment
for Part 1.
Part 1 was designed as a Phase II study exploring the efficacy and safety of tocilizumab
therapy versus placebo. Part 1 was intended to determine whether Part 2 of the study would
continue, based on a Week 12 analysis.
Part 2 was designed to provide pivotal Phase III efficacy and safety data for tocilizumab in
patients with AS. Approximately 400 patients were to be enrolled. Once randomization into
Part 1 was complete, randomization into Part 2 of the study was to be initiated.
Based on the results of the Week 12 Part 1 analyses of the primary endpoint (ASAS20) and
secondary endpoints, and in consideration of all available safety data, a benefit/risk
assessment was made and it was decided to halt the study because of lack of overall
efficacy. Most patients did not complete the 24-week double-blind treatment period in Part
2.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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