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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
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A nonsteroidal anti-inflammatory agent with potent analgesic and antiarthritic properties. It has been shown to be effective in the treatment of OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; ankylosing SPONDYLITIS; and in the alleviation of postoperative pain (PAIN, POSTOPERATIVE).
A recombinant version of soluble human TNF receptor that binds specifically to TUMOR NECROSIS FACTOR and inhibits its binding with endogenous TNF receptors. It prevents the inflammatory effect of TNF and is used to treat RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS and ANKYLOSING SPONDYLITIS.
Human histocompatibility (HLA) surface antigen encoded by the B locus on chromosome 6. It is strongly associated with acute anterior uveitis (UVEITIS, ANTERIOR); ANKYLOSING SPONDYLITIS; and REACTIVE ARTHRITIS.
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