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

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT02332590

Run by

Sanofi

People needed

369

Starts

2015-01-28

Expected to finish

2020-12-29

Last updated by the study team

2022-03-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of RA greater than or equal to (>=)3 months duration.
• American College of Rheumatology (ACR) Class I-III functional status.
• Active RA was defined as:
• At least 6 of 66 swollen joints and 8 of 68 tender joints, high sensitivity C-reactive protein (hs-CRP) >=8 mg/L or ESR >=28 millimeter per hour (mm/H), and DAS28-ESR greater than (>) 5.1.
• Participants as per Investigator judgment were either intolerant of, or considered inappropriate candidates for continued treatment with MTX, or after at least 12 weeks of continued treatment with MTX, or inadequate responders treated with an adequate MTX dose for at least 12 weeks.

You may not qualify if…

• Age <18 years or the legal age of consent in the country of the study site, whichever was higher.
• Current treatment with disease-modifying antirheumatic drug (DMARDs)/immunosuppressive agents including MTX, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 2 weeks prior to the baseline (Randomization Visit) or azathioprine, cyclophosphamide within 12 weeks prior to baseline (Randomization Visit) or leflunomide within 8 weeks prior to the Randomization Visit, or 4 weeks after cholestyramine washout.
• Treatment with any prior biologic agent, including anti-interleukin 6 (IL-6), IL-6 receptor (IL-6R) antagonists, and prior treatment with a Janus kinase inhibitor.
• Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening.
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840400 — Long Beach, California, United States
• Investigational Site Number 840141 — Whittier, California, United States
• Investigational Site Number 840130 — Lewes, Delaware, United States
• Investigational Site Number 840229 — Coral Gables, Florida, United States
• Investigational Site Number 840128 — Ormond Beach, Florida, United States
• Investigational Site Number 840403 — St. Petersburg, Florida, United States
• Investigational Site Number 840140 — Tampa, Florida, United States
• Investigational Site Number 840073 — Cumberland, Maryland, United States
• Investigational Site Number 840202 — Hagerstown, Maryland, United States
• Investigational Site Number 840232 — Flint, Michigan, United States
• Investigational Site Number 840112 — Lincoln, Nebraska, United States
• Investigational Site Number 840402 — Charlotte, North Carolina, United States
• Investigational Site Number 840406 — Hickory, North Carolina, United States
• Investigational Site Number 840404 — Middleburg Heights, Ohio, United States
• Investigational Site Number 840127 — Oklahoma City, Oklahoma, United States
• Investigational Site Number 840074 — Mesquite, Texas, United States
• Investigational Site Number 152005 — Osorno, Chile
• Investigational Site Number 152001 — Puerto Varas, Chile
• Investigational Site Number 152002 — Santiago, Chile
• Investigational Site Number 152050 — Santiago, Chile
• Investigational Site Number 152014 — Talca, Chile
• Investigational Site Number 152015 — Temuco IX Region, Chile
• Investigational Site Number 152007 — Viña del Mar, Chile
• Investigational Site Number 203001 — Prague, Czechia
• Investigational Site Number 840407 — Covina, California, United States

Full record on ClinicalTrials.gov

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