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

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 8

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the study is to evaluate the efficacy by (ASAS20)<br /><br>(Assessment in Ankylosing Spondylitis Working Group responses criteria) of<br /><br>SAR153191 in patients with AS (Ankylosing Spondylitis) at week 12 and to define<br /><br>the best dose/dosage regimen for further<br /><br>development.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives are:<br /><br>* assessment of higher level of response ASAS40;<br /><br>* ASAS partial remission;<br /><br>* disease activity (BASDAI) at Week 12;<br /><br>* range of motion assessed by (BASMI) (10-point scale);<br /><br>* Ankylosing Spondylitis Disease Activity Score (ASDAS);<br /><br>* safety and tolerability of SAR153191 in patients with AS;<br /><br>* and to document PK profile of SAR153191 in patients with AS;<br /><br>* MRI of the spine.</p><br>

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