A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS)
- Conditions
- 10007951Bechterew's DiseaseMarie Stümpell Disease
- Registration Number
- NL-OMON34640
- Lead Sponsor
- Sanofi-aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 6
I 01. Patients with AS that have completed 12 weeks of treatment in the DRI11073 study.
I 02. Patients must give informed consent for participating in the LTS11298 study prior to any procedure related to the study.
E 01. Any patients who experienced any adverse events leading to treatment discontinuation from the DRI11073 study.
E 02. Any abnormalities or adverse events at the last treatment visit of the DRI11073 study that per Investigator judgment would adversely affect patient*s participation in this study.
E 03. Positive pregnancy test at the last visit in the DRI 11073 study.
E 04. Breast-feeding women.
E 05. For women of childbearing potential, unwillingness to utilize adequate contraception methods or not become pregnant during the full course of the study. Adequate contraceptive measures include oral contraceptives (stable use for 2 or more cycles prior to screening) and other prescription pharmaceutical contraceptives; IUD; bilateral tubal legations; vasectomy; condom or diaphragm plus either contraceptive sponge, foam or jelly. If subject is on MTX and/ or any other concomitant medication, please follow their precautions and recommendations. For example, if a subject is on Methotrexate, which requires a longer term use of contraception, then the longer period should be used to protect safety of subject.
E 06. Men who are unwilling to utilize 2 form of contraception: a condom and a spermicidal agent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary objective is to assess the long term safety of SAR153191 in patients<br /><br>with ankylosing spondylitis.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Objective is to assess the long term efficacy of SAR153191 by<br /><br>(ASAS20).</p><br>