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-CZ
- 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
E01 Male and female patients age <18 of age or =75 years.
E02 Weight <50 kg for man or <45 Kg for women or >110 kg for both man or women.
E03 BASDAI score <4 (NRS 0-10) at screening and baseline.
E04 Total Back Pain score <4 (NRS 0-10) at screening and baseline.
E05 Patients with complete fusion of the spine.
E06 Patient who has previously participated in any clinical trial of SAR153191.
E07Participation 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.
E08 Have a history or presence of significant other concomitant illness according to the investigator’s judgment.
E09 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
protocol;
- Uncooperative or any condition that could make the patient potentially
non-compliant with study procedures.
E10 Starting treatment with NSAIDs <4 weeks prior to screening or change current
treatment or dose for =2 weeks prior to baseline.
E11 Treatment with oral prednisone or equivalent corticosteroids >10 mg/day within
6 weeks prior to screening.
E12 Use of intramuscular or intra-articular corticosteroids within the last 4 weeks before screening.
E13 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 stable dose for =12 weeks; and not to exceed the following dose:
- Methotrexate >25 mg/week;
- Hydroxychloroquine >400 mg/day;
- Sulfasalazine >3 gr/day.
E14 Past history of non response to any anti-TNFs treatment or non response to any other biological treatment for AS.
E15 Any past or current treatment with anti-TNFs agents or any biological agent within 3 months from screening.
E16 Pregnant or breast-feeding women.
E17 For women of childbearing potential, unwillingness to utilize adequate contraception or not become pregnant during full course of the study.
E18 History of alcohol or drug abuse within the 5 years prior to the Screening Visit.
E19 Any subject who has had surgery within 4 weeks prior to the Screening Visit or with planned elective surgery.
E20 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. History of lymphoproliferative disease or possible current lymphoproliferative disease.
E21 Patients with latent or active tuberculosis.
E22 Patients with history of Listeriosis or tuberculosis (unless documented that it was adequately treated) (see Section 10.2).
E23 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.
E24 Unhealed infected skin ulcers.
E25 Received administration of any
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