Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Sarilumab; Placebo; Golimumab; methotrexate (MTX); Folic/folinic acid
Intervention description: Pharmaceutical form: solution for injection
Route of administration: subcutaneous; Pharmaceutical form: solution for injection
Route of administration: subcutaneous; Pharmaceutical form: solution for injection
Route of administration: subcutaneous; Pharmaceutical form: tablet or solution for injection
Route of administration: Oral (tablet) or subcutaneous, intramuscular (solution); Pharmaceutical form: tablet
Route of administration: oral Folic/folinic acid continued according to local standard.
Intervention MeSH terms: Leucovorin; Folic Acid; Golimumab; Methotrexate; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      - To demonstrate that sarilumab (SAR153191/REGN88) on top of methotrexate (MTX) was superior
      in efficacy to placebo for the relief of signs and symptoms of rheumatoid arthritis (RA), in
      participants with active RA who had failed up to 2 tumor necrosis factor-alpha (TNF-α)
      antagonists.

      Secondary Objectives:

        -  To assess the safety of sarilumab;

        -  To document the pharmacokinetic profile of sarilumab.
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis of rheumatoid arthritis ≥6 months duration and American College of
             Rheumatology (ACR) Class I-III functional status at screening and baseline visits;

          -  Active disease defined as:

               -  At least 6 of 68 tender joints and 6 of 66 swollen joints at screening and
                  baseline visits, and

               -  hs-C-Reactive Protein (hs-CRP) >10 g/L or Erythrocyte Sedimentation Rate (ESR)
                  >28 mm/hr at screening visit;

          -  Continuous treatment with Methotrexate for at least 12 weeks and on stable dose
             (minimum 10 mg/week) for at least 6 weeks prior to the screening visit;

          -  Participant considered as Primary TNF-α blocker nonresponder. i.e.:

               -  Appropriate for previous TNF-α blocker therapy

               -  Lack of adequate clinical response after at least 3 months TNF-α blocker therapy
                  with MTX or other synthetic disease modifying anti-rheumatic drug (DMARD)
                  co-therapy.

        Exclusion criteria:

          -  Age <18 years or >75 years;

          -  Pregnant or breastfeeding woman or woman of childbearing potential, unwilling to
             utilize adequate contraception or not to become pregnant during the entire study;

          -  Fever (>38°C), or chronic, persistent, or recurring infection(s);

          -  History of demyelinating disease;

          -  Current underlying hepatobiliary disease.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.