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
Clinical Trials
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...
Evaluation of SAR153191(REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients
Primary Objectives: - To demonstrate that SAR153191 on top of Methotrexate (MTX) is effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks (Part A) ...
Increasing Physical Activity in Ankylosing Spondylitis: a Randomised Controlled Trial
Ankylosing spondylitis is a chronic inflammatory condition that mostly affects the spine. This results in back pain and stiffness, and causes difficulty with daily activities. Physical act...
Evaluation of Low Dose Infliximab in Ankylosing Spondylitis (Study P04352)(COMPLETED)
This is a randomized, double-blind, multi-center, placebo-controlled study with two parallel treatment groups (placebo and infliximab) in subjects with ankylosing spondylitis (AS) to evalu...
Pilot Open Label Clinical Trial With Abatacept in Ankylosing Spondylitis
This is an open-label trial investigating the efficacy and safety of abatacept in ankylosing spondylitis. It is planned to treat 30 patients with ankylosing spondylitis from baseline up to...
PubMed Articles
Tumor necrosis factor (TNF) inhibitors significantly improved the treatment options for patients with ankylosing spondylitis. Unfortunately, currently, there is no strategy for sustaining remission of...
Ankylosing spondylitis is a degenerative and inflammatory rheumatologic disorder that primarily affects the spine. Delayed diagnosis leads to debilitating spinal damage. This study examines biomechani...
Influence of HLA-B27 on the Ankylosing Spondylitis phenotype: results from the REGISPONSER database.
To assess HLA-B27 influence on the clinical phenotype of Ankylosing Spondylitis (AS) patients.
To investigate the pathogenesis of pseudarthrosis in ankylosing spondylitis (AS) based on the pathological analysis of specimens harvested during surgery.
Audiologic profile in patients with ankylosing spondylitis: A controlled study of 30 patients.
Recent studies have identified sensorineural hearing loss as a possible manifestation of ankylosing spondylitis. We conducted a study of 30 patients with ankylosing spondylitis to characterize their a...
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.
