NCT02332590

Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)

A Randomized, Double-blind, Parallel-group Study Assessing the Efficacy and Safety of Sarilumab Monotherapy Versus Adalimumab Monotherapy in Patients With Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 369 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Total study duration was up to 310 weeks: Up to a 4 week screening period, 24 week randomized double-blind treatment phase, 276-week open-label extension, and 6 weeks post-treatment final study visit.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Sarilumab	Pharmaceutical form: solution for injection in pre-filled syringe; Route of administration: SC
DRUG	Adalimumab	Pharmaceutical form: solution for injection in pre-filled syringe; Route of administration: SC
DRUG	Placebo (for sarilumab)	Pharmaceutical form: solution for injection in pre-filled syringe; Route of administration: SC
DRUG	Placebo (for adalimumab)	Pharmaceutical form: solution for injection in pre-filled syringe; Route of administration: SC

Timeline

• Start date: 2015-01-28
• Primary completion: 2016-01-20
• Completion: 2020-12-29
• First posted: 2015-01-07
• Last updated: 2022-03-28
• Results posted: 2017-07-25

Locations

86 sites across 15 countries: United States, Chile, Czechia, Germany, Hungary, Israel, Peru, Poland, Romania, Russia, South Africa, South Korea, Spain, Ukraine, United Kingdom