Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Sarilumab; Adalimumab; Placebo (for sarilumab); Placebo (for adalimumab)
Intervention description: Pharmaceutical form: solution for injection in pre-filled syringe; Route of administration: SC; Pharmaceutical form: solution for injection in pre-filled syringe; Route of administration: SC; Pharmaceutical form: solution for injection in pre-filled syringe; Route of administration: SC; Pharmaceutical form: solution for injection in pre-filled syringe; Route of administration: SC
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: During the OLE period of this study, all participants received sarilumab 200 mg or 150 mg q2w via prefilled syringe.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 369.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion criteria:

          -  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.

        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.