Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis
Summary
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
Description
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.
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Ankylosing Spondylitis
Intervention
SAR153191 (REGN88), placebo
Location
Sanofi-Aventis Investigational Site Number 840006
Birmingham
Alabama
United States
35205
Status
Recruiting
Source
Sanofi-Aventis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01061723
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-23T21:10:51-0400
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Medical and Biotech [MESH] Definitions
Infliximab
A chimeric monoclonal antibody to TNF ALPHA that is used in the treatment of RHEUMATOID ARTHRITIS; ANKYLOSING SPONDYLITIS; PSORIATIC ARTHRITIS and CROHN'S DISEASE.
Phenylbutazone
A butyl-diphenyl-pyrazolidinedione that has anti-inflammatory, antipyretic, and analgesic activities. It has been used in ANKYLOSING SPONDYLITIS; RHEUMATOID ARTHRITIS; and REACTIVE ARTHRITIS.
Etodolac
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).
Etanercept
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.
Hla-b27 Antigen
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.
