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Sponsor: Sanofi
Conditions: Ankylosing Spondylitis
Interventions: Sarilumab, Placebo
Countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany
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
Sex: ALL
Age: 18 Years to 75 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion criteria: * 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 Exclusion criteria: * \<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.
- Birmingham, Alabama, United States
- Anaheim, California, United States
- Los Angeles, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Upland, California, United States
- Boca Raton, Florida, United States
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- Hobart, Australia
- Malvern East, Australia
- Shenton Park, Australia
- Woolloongabba, Australia
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