An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

Overview

Primary Objective: To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and MTX in participants with rheumatoid arthritis (RA) and an inadequate response to adalimumab and MTX by evaluation of the Disease Activity Score for 28 joints (DAS28). Secondary Objectives: To assess the signs and symptoms of RA in participants taking sarilumab in combination with MTX. To assess the quality of life of participants with RA taking sarilumab in combination with MTX. To assess the safety and tolerability of sarilumab in combination with MTX in participants with RA.

The maximum study duration per participant enrolled in the open label run-in phase and was eligible to enroll in the randomized phase of main study was 54 weeks: * open label screening period of up to 4 weeks * open-label treatment period of 16 weeks * randomized screening period of 2 to 4 weeks * randomized treatment post-treatment safety follow-up period of 6 weeks. The maximum study duration per participant enrolled only in the open label run-in phase and was not eligible to enroll in the randomized phase of main study was 26 weeks: * open label screening period of up to 4 weeks * open-label treatment period of 16 weeks * open label treatment post-treatment safety follow-up period of 6 weeks. The maximum study duration per participant enrolled in the open label run-in phase and was eligible to enroll in the sarilumab sub-study was 82 weeks: * open label screening period of up to 4 weeks * open-label treatment period of 16 weeks * screening period of 2 to 4 weeks * sarilumab treatment period of 52 weeks * sub-study post-treatment safety follow-up period of 6 weeks.