To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Exclusion Criteria

• •Participants \<18 years of age. Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening
• •Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, or a change in dosage within 4 weeks prior to screening
• •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 systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty's syndrome
• •Participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the Screening Visit, whichever was longer
• •Participants with active tuberculosis or latent tuberculosis infection. Prior or current history of interstitial lung disease. Prior treatment with anti-interleukin (IL) -6 or anti-IL-6R therapies, including but not limited to tocilizumab or sarilumab
• •Treatment with anti-TNF agents, as follows:
• •Etanercept: within 28 days prior to randomization
• •Infliximab, adalimumab, golimumab, certolizumab pegol: within 42 days prior to randomization
• •Treatment with RA-directed biologic agents with non- TNF-α antagonist mechanisms without adequate washout as follows:
• •Anakinra: within 28 days prior to randomization
• •Abatacept: within 42 days prior to randomization
• •Rituximab or other cell depleting agent: Within 6 months prior to randomization or until total lymphocyte count and CD 19+ lymphocyte count were normalized, or whichever was longer
• •Prior treatment with a janus kinase (JAK) inhibitor (eg, tofacitinib). Participants with a history of invasive opportunistic infection. Prior or current history of malignancy, including lymphoproliferative diseases, other than adequately-treated carcinoma in-situ of the cervix, nonmetastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the randomization (baseline) visit
• •Prior or current history of other significant concomitant illness(es) that, according to Investigator's judgement, was adversely affect the participant's participation in the study.
• •The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.