Primary Objectives: Part A (dose ranging study): To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks. Part B (pivotal study): To demonstrate that sarilumab added to MTX was effective in: * reduction of signs and symptoms of rheumatoid arthritis at 24 weeks * inhibition of progression of structural damage at 52 weeks * improvement in physical function at 16 weeks Secondary Objectives: Part B: To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks To assess the safety of sarilumab added to MTX To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy.
The total study duration for a participant was 16-22 weeks (Part A) and 56-62 weeks (Part B) broken down as follows: * Screening: Up to 4 weeks * Treatment: 12 weeks (Part A) and 52 weeks (Part B)\* * Follow-up: 6 weeks (for participants who would not continue in the long-term extension study). '\*' Participants successfully completing their treatment period would be offered the opportunity to enter the long term extension study LTS11210 (SARIL-RA-EXTEND) (NCT01146652).
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Same weekly dose as received prior to enrollment
According to local standard
Buenos Aires, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Caba, Argentina
Córdoba, Argentina
Córdoba, Argentina
Mar del Plata, Argentina
Quilmes, Argentina
Ramos Mejía, Argentina
Rosario, Argentina
San Miguel de Tucumán, Argentina
Zárate, Argentina