Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis

Inclusion criteria: 1. Male or female Japanese who are 20 to 65 years of age 2. Diagnosis of rheumatoid arthritis (RA) ≥ 3 months duration 3. Treated for a minimum of 8 weeks with Methotrexate (MTX) and with a stable dose of MTX (6-16 mg/week) for a minimum of 4 weeks prior to the screening visit Exclusion criteria: 1. Autoimmune or inflammatory systemic or localized joint disease other than RA 2. Women of a positive pregnancy test 3. Latent or active tuberculosis 4. Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist 5. Treatment with anti-TNF agents, as follows: 1. Etanercept: within 28 days prior to randomization 2. Infliximab, adalimumab, golimumab, certolizumab pegol: within 42 days prior to randomization 6. Received any live, attenuated vaccine within 3 months prior to the randomization visit (eg, varicella-zoster, oral polio, rubella vaccines) 7. Significant concomitant illness such as, but not limited to, cardiovascular, renal, neurological, endocrinological, gastrointestinal, hepato-biliary, metabolic, pulmonary or lymphatic disease that would adversely affect the patient's participation in the study. 8. Received surgery within 4 weeks prior to the screening visit or planned surgery during the study 9. History of a systemic hypersensitivity reaction The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.