To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: sarilumab SAR153191 (REGN88)
Intervention description: Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To evaluate the immunogenicity of sarilumab administered as monotherapy.

      Secondary Objectives:

        -  To evaluate the other safety aspects of sarilumab administered as monotherapy.

        -  To assess the exposure of sarilumab administered as monotherapy.
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis of rheumatoid arthritis (RA) ≥ 3 months.

          -  Moderately to severely active rheumatoid arthritis.

          -  Participants who per investigator judgment were incomplete responders to at least 12
             weeks of an adequate dose of continuous treatment with or who were intolerant of one
             or a combination of non-biologic disease modifying anti-rheumatic drugs (DMARDs).

        Exclusion criteria:

          -  Participants < 18 years of age.

          -  Past history of, or current, autoimmune or inflammatory systemic or localized joint
             disease(s) other than RA.

          -  History of juvenile idiopathic arthritis or arthritis onset prior to age 16.

          -  Severe active systemic RA, including but not limited to vasculitis, pulmonary
             fibrosis, and/or Felty's syndrome.

          -  Prior treatment with any biologic anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R)
             antagonist therapies.

          -  Treatment with prednisone > 10 mg or equivalent per day, or change in dosage within 4
             weeks prior to randomization.

          -  New treatment with or dose-adjustment of on-going nonsteroidal anti-inflammatory drug
             (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors within 4 weeks prior to randomization,
             except for the use of low-dose acetylsalicylic acid for cardiovascular diseases.

          -  Use of parenteral glucocorticoids or intra-articular glucocorticoids injection within
             4 weeks prior to randomization.

          -  Prior treatment with a Janus kinase (JAK) inhibitor (tofacitinib).

          -  New treatment or dose-adjustment to on-going medication for dyslipidemia, such as
             statin, within 6 weeks prior to randomization.

          -  Participation in any clinical research study evaluating another investigational drug
             or therapy within 5 half-lives or 60 days of first dose of study drug administration,
             whichever is longer.

          -  Participants with a history of malignancy other than adequately-treated carcinoma
             in-situ of the cervix, non-metastatic squamous cell or basal cell carcinoma of the
             skin, within 5 years prior to the randomization visit. Non-malignant
             lymphoproliferative disorders are also excluded.

          -  Participants with active tuberculosis or untreated latent tuberculosis infection.

          -  Pregnant or breast feeding women.

        The above information is not intended to contain all considerations relevant to a
        Participant's potential participation in a clinical trial.