A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)
- Conditions
- Rheumatoid ArthritisMedDRA version: 12.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
- Registration Number
- EUCTR2010-019262-86-GR
- Lead Sponsor
- sanofi-aventis Recherche & Développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1500
I 01. 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.
I 02. Patients must give informed consent for participating in the study LTS11210 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. Patients not willing to continue to take folic acid 5 mg weekly or greater with the MTX dose, to minimize toxicity.
E 02. Patients with any contraindications to MTX according to SmPC or investigators judgment.
E 03. Any patient who experienced an adverse event leading to discontinuation from EFC11072.
E 04. 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
E 05. Subject with an active TB at the last treatment visit in the study EFC11072.
E 06. Female of child bearing potential with a positive pregnancy test.
E 07. For women of childbearing potential (WOCBP), unwillingness to utilize adequate
contraception methods or not become pregnant during the full course of the study.
Adequate contraceptive measures include oral contraceptives or other prescription
pharmaceutical contraceptives (stable use for 2 or more cycles prior to screening); IUD; bilateral tubal legations; vasectomy; dual barrier: 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 08. 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
- Primary Outcome Measures
Name Time Method Secondary Objective: The percentages of patients who reach ACR20, DAS28 and EULAR response overtime;Primary end point(s): Incidence of adverse events;Main Objective: The primary objective of the study is to evaluate the long term safety of SAR153191 in patients with RA on top of DMARDs
- Secondary Outcome Measures
Name Time Method