Ankylosing Spondylitis Clinical Trial
Official title:
A Randomized Double Blind-placebo Controlled Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 in Patients With Ankylosing Spondylitis (AS)
Primary objective:
- to evaluate the efficacy of Sarilumab in patients with Ankylosing Spondylitis [AS] using
the Assessment in AS working group criteria [ASAS] 20% response criteria [ASAS20]
Secondary objectives:
- to demonstrate that Sarilumab is effective on:
- assessment of higher level of response (ASAS 40% response criteria [ASAS40])
- partial remission
- disease activity
- range of motion
- Magnetic Resonance Imaging [MRI] of the spine
- to assess the safety and tolerability of Sarilumab in patients with AS as well as the
pharmacokinetic profile of Sarilumab in patients with AS
The duration of participation in this study for each patient was approximately 22 weeks; including up to 4 weeks screening period, 12-week double-blind treatment period and 6-week safety follow-up period. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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