A randomized, double-blind, parallel-group, placebo- and active calibrator-controlled study assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a
- Conditions
- -M05M05
- Registration Number
- PER-104-10
- Lead Sponsor
- sanofi-aventis Recherche & Development,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Diagnosis of rheumatoid arthritis> 6 months duration and functional status Class I-III of the American College of Rheumatology (ACR) in the selection and baseline.
• Active disease
• Continuous treatment with MTX for at least 12 weeks prior to selection and maintaining a stable dose (minimum 10 mg / week) for at least 6 weeks prior to the selection visit.
• Not responding to the primary TNF-a blocker (up to 2 agents)
• Patients who have signed an informed written consent prior to performing any of the procedures related to the study.
• Age <18 years or> 75 years.
• Treatment with DMARD (other than MTX) in a period of 4 weeks or 12 weeks prior to the baseline visit (depending on DMARDs) (see Section 7.3.1)
• Use of parenteral glucocorticoids or intraarticular glucocorticoids in a period of 4 weeks prior to the baseline visit.
• Use of an oral prednisone glucocorticoid greater than 10 mg per day or equivalent per day, or a change in dosage over a period of 4 weeks prior to the baseline visit.
• Previous treatment with golimumab.
• Previous treatment with anti-IL-6 therapies or IL-6R antagonists, including tocilizumab or SAR15319I or other experimental therapies.
• Treatment with a TNF-a blocker in a period of 4 weeks (etanercept), in a period of 6 weeks (infliximab, adalimumab, certolizumab pegol), prior to the baseline visit.
• Treatment with biological agents targeting RA with non-TNF-a antagonistic mechanisms, in a period of 4 weeks (anakinra), 6 weeks (abatacept), 6 months (rituximab) with a normal lymphocyte count, prior to baseline.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Percentage of patients who achieve an improvement of 20% from baseline to 12 weeks, evaluated according to the disease activity index of the central group of the American College of Rheumatology [ACR]<br>Measure:Improvement in the ACR20% response rate (composite index) at 12 weeks.<br>Timepoints:Week 12<br>
- Secondary Outcome Measures
Name Time Method