A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIG

Sanofi-aventis0 个研究点目标入组 8 人开始时间: 待定最近更新: 2024年5月6日

研究概览

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•* Male and Female *18 years old and <75 years old with the diagnosis AS according to the modified New York criteria.
•* Patient 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
•* Patients must have active AS for *3 months before screening and active disease must be present at screening and at baseline
•* Active AS is defined by:
•- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of *4 Numerical Rating Scale
•(NRS 0-10)
•- Total back pain score *4 (NRS 0-10)
•* Patients treated with corticosteroid must be on a stable dose for *2 weeks prior to baseline
•* Patients treated with Disease Modifying Anti-Rheumatic Drugs (DMARDs): hydroxychloroquine, sulfasalazine and methotrexate (MTX); must be on stable dose *12 weeks prior to baseline

•* Patients <18 years old and *75 years old
•* Patients with 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 agents or any biological agent within 3 months prior to screening.
•* Patients treated 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
•* Patients who had previously been treated with cyclosporine or azathioprine

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