Primary Objective: To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) were effective for: * reduction of signs and symptoms at Week 24 and * improvement of physical function at Week 12 in participants with active rheumatoid arthritis (RA) who were inadequate responders or intolerant to tumor necrosis factor alpha (TNF-α) antagonists. Secondary Objectives: The secondary objectives were to investigate the effects of SAR153191 (REGN88) when added to DMARD therapy, in participants with active RA who were inadequate responders or intolerant to TNF-α antagonists, for: * Reduction of signs and symptoms at Week 12; * Improvement in physical function at Week 24; * Improvement in disease activity score as measured by other American College of Rheumatology (ACR) derived components at Weeks 12 and 24; * Improvement in quality of life as measured by participant reported outcomes (PROs) at intermediate visits and Week 24. To assess the exposure of sarilumab added to DMARD therapy in this population. To assess the safety of sarilumab in this population.
Total study duration was up to 34 weeks: screening up to 28 days, treatment phase of 24 weeks, and post-treatment follow-up of 6 weeks. After completion of the treatment phase of this study, participant were eligible to enter a long term safety study (LTS11210) for active treatment with SAR153191 (REGN88).
Pharmaceutical form:solution Route of administration: subcutaneous
Pharmaceutical form:solution Route of administration: subcutaneous
Dispensed according to the local practice.
Dispensed according to the local practice.
Dispensed according to the local practice.
Dispensed according to the local practice.
Buenos Aires, Argentina
Buenos Aires, Argentina
Caba, Argentina
Caba, Argentina
Capital Federal, Argentina
Córdoba, Argentina
La Plata, Argentina
Ramos Mejía, Argentina
Rosario, Argentina
San Miguel de Tucumán, Argentina
Zárate, Argentina