An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Sarilumab; Etanercept; Methotrexate; Placebo (for sarilumab); Placebo (for etanercept); Adalimumab
Intervention description: Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous; Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous; Dispensed according to local practice.; Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
Intervention MeSH terms: Adalimumab; Etanercept; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 776.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to
      etanercept and MTX in participants with rheumatoid arthritis (RA) and an inadequate response
      to adalimumab and MTX by evaluation of the Disease Activity Score for 28 joints (DAS28).

      Secondary Objectives:

      To assess the signs and symptoms of RA in participants taking sarilumab in combination with
      MTX.

      To assess the quality of life of participants with RA taking sarilumab in combination with
      MTX.

      To assess the safety and tolerability of sarilumab in combination with MTX in participants
      with RA.
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis of RA >/= 3 months duration.

          -  Continuous treatment of MTX 10 - 25 mg/week (or per local labeling requirements if the
             dose range differs) for at least 12 weeks before screening visit and on a stable dose
             for 8 weeks before screening visit.

          -  Active disease defined as: at least 6/66 swollen and 8/68 tender joints and high
             sensitivity C-reactive protein > 10 mg/L.

        Exclusion criteria:

          -  Age < 18 years.

          -  Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks of
             the screening visit.

          -  Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per
             day, or a change in dosage within 4 weeks of the screening visit.

          -  Prior treatment with a tumor necrosis factor (TNF)-alpha inhibitor, or other
             biological disease modifying anti-rheumatoid drug (DMARD) or Janus Kinase inhibitor.

          -  New treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory drugs
             (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors within 4 weeks of the screening
             visit.

          -  Treatment with traditional oral DMARD /immunosuppressive agents other than MTX within
             4 weeks or 12 weeks before the screening visit, depending on DMARD.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.