A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDs
Status:
Terminated
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
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.