Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)
Status:
Completed
Trial end date:
2020-12-29
Target enrollment:
Participant gender:
Summary
Primary Objective:
To demonstrate that sarilumab monotherapy was superior to adalimumab monotherapy with respect
to signs and symptoms as assessed by disease activity score 28 (DAS28)-erythrocyte
sedimentation rate (ESR) in participants with active rheumatoid arthritis (RA) who were
either intolerant of, or considered inappropriate candidates for continued treatment with
methotrexate (MTX), or after at least 12 weeks of continued treatment with MTX, were
determined to be inadequate responders.
Secondary Objectives:
To demonstrate that sarilumab monotherapy was superior to adalimumab monotherapy in
participants with active RA who were either intolerant of, or considered inappropriate
candidates for continued treatment with MTX, or after at least 12 weeks of continued
treatment with MTX, were determined to be inadequate responders, with respect to:
- Reduction of signs and symptoms of RA.
- Improvement in quality of life assessed by participant reported outcome questionnaires.
Assessment of the safety and tolerability of sarilumab monotherapy (including immunogenicity)
throughout the study.