Conditions: Spondylitis, Ankylosing
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 113
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Patients received tocilizumab 4 mg/kg intravenously every 4 weeks for 24 weeks. arm 2: Patients received tocilizumab 8 mg/kg intravenously every 4 weeks for 24 weeks. arm 3: Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.

Interventions: intervention 1: Tocilizumab intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: