A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIG
- Conditions
- Ankylosing SpondylitisMedDRA version: 12.0Level: LLTClassification code 10002556Term: Ankylosing spondylitis
- Registration Number
- EUCTR2009-016068-35-FR
- Lead Sponsor
- Sanofi-aventis Recherche & Développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
I 01. Patients with active AS based on the Modified New York criteria for ankylosing
spondylitis.
I 02. Patients must had an adequate trial of at least 2 different NSAIDs taking for at least 2 weeks in each case and on a stable dose for =2 weeks or be intolerant to NSAIDs.
I 03. Active disease must be present for =3 months and be present at screening and at baseline as defined:
- Bath AS Disease Activity Index (BASDAI) score of =4 (NRS 0-10);
- Total back pain score =4 (NRS 0-10).
I 04. Patients treated with corticosteroid must be on a stable dose for >2 weeks prior to baseline.
I 05. Patients treated with DMARDs: hydroxychloroquine, sulfasalazine and MTX must be on a stable dose =12 weeks.
I 06. Patients must give informed consent prior to any procedure related to the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
E 01. Male and female patients age <18 of age or =75 years.
E 02. Weight <50 kg for man or <45 Kg for women or >110 kg for both man or women.
E 03. BASDAI score <4 (NRS 0-10) at screening and at baseline.
E 04. Total Back Pain score <4 (NRS 0-10) at screening and at baseline.
E 05. Patients with complete fusion of the spine.
E 06. Patient who has previously participated in any clinical trial of SAR153191.
E 07. Participation in any clinical research study evaluating another investigational drug or therapy within 60 days or at least 5 half-lives, whichever is longer, of the
investigational drug, prior to the Screening Visit.
E 08. Have a history or presence of significant other concomitant illness according to the investigator’s judgment.
E 09. Conditions/situations such as:
- Patients with short life expectancy;
- Patients with conditions/concomitant diseases making them non-evaluable for the
primary efficacy endpoint;
- Requirement for concomitant treatment that could bias primary evaluation;
- Impossibility to meet specific protocol requirements;
- Patient is the Investigator or any sub-Investigator, research assistant, pharmacist,
study coordinator, other staff or relative thereof directly involved in the conduct of
the protocol;
- Uncooperative or any condition that could make the patient potentially
non-compliant with the study procedures.
E 10. Starting treatment with NSAIDs <4 weeks prior to screening or change current
treatment or dose for =2 weeks prior to baseline.
E 11. Treatment with oral prednisone or equivalent corticosteroids >10 mg/day within
6 weeks prior to screening.
E 12. Use of intramuscular or intra-articular corticosteroids within the last 4 weeks before screening.
E 13. Patients who had previously been treated or are currently treated with Disease
Modifying Anti-Rheumatic Drugs or with cyclosporine, azathioprine, or DMARDs
other than methotrexate, sulfasalazine and hydroxychloroquine; and must be on a stable dose for =12 weeks; and not to exceed the following dose:
- Methotrexate >25 mg/week;
- Hydroxychloroquine >400 mg/day;
- Sulfasalazine >3 gr/day.
E 14. Past history of non response to any anti-TNFs treatment or non response to any other biological treatment for AS.
E 15. Any past or current treatment with anti-TNFs agents or any biological agent within 3 months from screening.
E 16. Pregnant or breast-feeding women.
E 17. For women of childbearing potential, unwillingness to utilize adequate contraception or not become pregnant during the full course of the study.
E 18. History of alcohol or drug abuse within the 5 years prior to the Screening Visit.
E 19. Any subject who has had surgery within 4 weeks prior to the Screening Visit or with planned elective surgery.
E 20. History of malignancy other than effectively treated carcinoma in-situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin within five years prior to Screening Visit.
E 21. Patients with a latent or active tuberculosis.
E 22. Patients with a history of Listeriosis or tuberculosis (unless documented that it was adequately treated) (see Section 10.2).
E 23. Fever (=38°C) or persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the Screening Visit, or history of frequent recurrent infections unacceptable per investigator judgment.
E 24. Unhealed infected skin ulcers.
E 25. Received administration of any live (attenua
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to evaluate the efficacy by (ASAS20) (Assessment in Ankylosing Spondylitis Working Group responses criteria) of SAR153191 in patients with AS (Ankylosing Spondylitis);Secondary Objective: The secondary objectives are:<br>assessment of higher level of response ASAS40<br>partial remission<br>disease activity<br>range of motion<br>changes in MRI score<br>the safety and tolerability of SAR153191 in patients with AS<br>to document PK profile of SAR153191 in patients with AS;Primary end point(s): The primary efficacy endpoint will be the percentage of patients who achieve the assessment in AS International Working Group Criteria for improvement (ASAS20) at Week 12
- Secondary Outcome Measures
Name Time Method