Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Ankylosing Spondylitis

In brief

Primary objective: \- to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS) using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20) Secondary objectives: * to demonstrate that Sarilumab was 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 participants with AS as well as the pharmacokinetic profile of Sarilumab in participants with AS

Key facts

Study ID

NCT01061723

Run by

Sanofi

People needed

301

Starts

2010-02-01

Expected to finish

2011-06-01

Last updated by the study team

2017-08-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of AS according to the New York modified criteria
• Participants must had an adequate trial of at least 2 different Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) taken for at least 2 weeks in each case and, on a stable dose for ≥2 weeks or be intolerant to NSAIDs
• Participants must had active AS for ≥3 months before screening and active disease must be present at screening and at baseline; Active AS being defined by:
• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥4 (Numerical Rating Scale 0-10)
• Total back pain score ≥4 (Numerical Rating Scale 0-10)
• Participants treated with corticosteroid must be on a stable dose for ≥2 weeks prior to baseline
• Participants treated with the Disease Modifying Anti-Rheumatic Drugs (DMARDs) hydroxychloroquine, sulfasalazine and methotrexate (MTX) must be on stable dose ≥12 weeks prior to baseline

You may not qualify if…

• <18 years old or ≥75 years old
• Complete fusion of the spine
• Past history of non response to any anti-Tumor Necrosis Factors (TNFs) treatment or non response to any other biological treatment for AS
• Any past or current treatment with anti-TNF's or any biological agent within 3 months prior to screening
• Treatment with DMARDs except for hydroxychloroquine, sulfasalazine and MTX
• MTX >25 mg/week
• hydroxychloroquine >400 mg/day
• Sulfasalazine >3 g/day
• Treatment with oral prednisone or equivalent corticosteroids >10 mg/day within 6 weeks prior to screening
• Use of intramuscular or intra-articular corticosteroids within the last 4 weeks before screening
• Previous treatment with cyclosporine, azathioprine
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840033 — Anaheim, California, United States
• Investigational Site Number 840027 — Los Angeles, California, United States
• Investigational Site Number 840007 — San Diego, California, United States
• Investigational Site Number 840013 — San Francisco, California, United States
• Investigational Site Number 840017 — Upland, California, United States
• Investigational Site Number 840009 — Boca Raton, Florida, United States
• Investigational Site Number 840001 — Naples, Florida, United States
• Investigational Site Number 840032 — Orlando, Florida, United States
• Investigational Site Number 840015 — Boise, Idaho, United States
• Investigational Site Number 840021 — Rock Island, Illinois, United States
• Investigational Site Number 840018 — Kansas City, Kansas, United States
• Investigational Site Number 840003 — Wheaton, Maryland, United States
• Investigational Site Number 840029 — Worcester, Massachusetts, United States
• Investigational Site Number 840008 — Lansing, Michigan, United States
• Investigational Site Number 840002 — St Louis, Missouri, United States
• Investigational Site Number 840028 — Freehold, New Jersey, United States
• Investigational Site Number 840016 — Albany, New York, United States
• Investigational Site Number 840036 — Syracuse, New York, United States
• Investigational Site Number 840010 — Toledo, Ohio, United States
• Investigational Site Number 840005 — Oklahoma City, Oklahoma, United States
• Investigational Site Number 840023 — Bethlehem, Pennsylvania, United States
• Investigational Site Number 840014 — Duncansville, Pennsylvania, United States
• Investigational Site Number 840004 — Dallas, Texas, United States
• Investigational Site Number 840030 — Houston, Texas, United States
• Investigational Site Number 840006 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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