A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAI

• Conditions: Ankylosing Spondylitis; MedDRA version: 12.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis

• Registration Number: EUCTR2010-019263-11-AT
• Lead Sponsor: sanofi-aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-13
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

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.

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

Exclusion Criteria

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 clinical trial of medicinal product
• Study Design: Not specified