A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)
- Conditions
- arthritisRA10003816
- Registration Number
- NL-OMON34585
- Lead Sponsor
- Sanofi-aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 19
- Patients with RA who were randomized in the study EFC11072 (a randomized,
double-blind, placebo-controlled study in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy)
• and who have completed Part A (12 weeks) or Part B (52 weeks) of the study EFC11072.
• or patients randomized in Part B of EFC11072 to a treatment arm subsequently not
retained following pivotal dose selection.
- Patients must give informed consent for participating in the study LTS11210 prior to any procedure related to the study.
- Patients not willing to continue to take folic acid 5 mg weekly or greater with the MTX dose, to minimize toxicity.
- Patients with any contraindications to MTX according to SmPC or investigators judgment.
- Any patient who experienced an adverse event leading to discontinuation from EFC11072.
- Any abnormalities or adverse events at screening (last treatment visit in the study EFC11072 will be the screening visit) that per investigator judgment would adversely affect patient*s participation in this study
- Subject with an active TB at the last treatment visit in the study EFC11072.
- Female of child bearing potential with a positive pregnancy test.
- For women of childbearing potential (WOCBP), unwillingness to utilize adequate
contraception methods or not become pregnant during the full course of the study.
- 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>The primary objective of the study is to evaluate the long term safety of<br /><br>SAR153191 in patients with RA on top of DMARDs.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The percentages of patients who reach ACR20, DAS28 and EULARresponse overtime.</p><br>