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Primary objective of the study:
- to evaluate the efficacy by (ASAS20) (Assessment in Ankylosing Spondylitis Working Group responses criteria) of SAR153191 in patients with AS (Ankylosing Spondylitis)
The secondary objectives are:
- assessment of higher level of response ASAS40
- partial remission
- disease activity
- range of motion
- changes in Magnetic Resonance Imaging (MRI) score
- the safety and tolerability of SAR153191 in patients with AS
- to document pharmacokinetic profile of SAR153191 in patients with AS
The duration of participation in this study for each patient will be approximately 20 weeks; including a 2 week screening period, a 12 week double-blind treatment and a 6 weeks safety follow-up period.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
SAR153191 (REGN88), placebo
Sanofi-Aventis Investigational Site Number 840006
Published on BioPortfolio: 2014-07-23T21:10:51-0400
Primary Objective: - To assess the long term safety of SAR153191 in patients with ankylosing spondylitis Secondary Objective: - To assess the long term efficacy of SAR153191...
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