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



Status:Active, not recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:10/28/2018
Start Date:February 2015
End Date:December 2020

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

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.

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.

Inclusion criteria:

- Diagnosis of RA ≥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 mm/H, and DAS28-ESR >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.

Exclusion criteria:

- 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.
We found this trial at
18
sites
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Lincoln, NE
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Charlotte, North Carolina 28207
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Charlotte, NC
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Coral Gables, FL
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Covina, CA
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Cumberland, MD
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Flint, MI
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Hagerstown, MD
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from
Hickory, NC
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Lewes, DE
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Long Beach, CA
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Mesquite, TX
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mi
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Middleburg Heights, OH
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mi
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Oklahoma City, OK
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Ormond Beach, FL
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Osorno,
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Saint Petersburg, Florida 33713
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from
Saint Petersburg, FL
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Tampa, FL
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Whittier, CA
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