Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers

Inclusion criteria: * Diagnosis of rheumatoid arthritis ≥6 months duration and American College of Rheumatology (ACR) Class I-III functional status at screening and baseline visits; * Active disease defined as: * At least 6 of 68 tender joints and 6 of 66 swollen joints at screening and baseline visits, and * hs-C-Reactive Protein (hs-CRP) \>10 g/L or Erythrocyte Sedimentation Rate (ESR) \>28 mm/hr at screening visit; * Continuous treatment with Methotrexate for at least 12 weeks and on stable dose (minimum 10 mg/week) for at least 6 weeks prior to the screening visit; * Participant considered as Primary TNF-α blocker nonresponder. i.e.: * Appropriate for previous TNF-α blocker therapy * Lack of adequate clinical response after at least 3 months TNF-α blocker therapy with MTX or other synthetic disease modifying anti-rheumatic drug (DMARD) co-therapy. Exclusion criteria: * Age \<18 years or \>75 years; * Pregnant or breastfeeding woman or woman of childbearing potential, unwilling to utilize adequate contraception or not to become pregnant during the entire study; * Fever (\>38°C), or chronic, persistent, or recurring infection(s); * History of demyelinating disease; * Current underlying hepatobiliary disease. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.