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

Total study duration per patient is up to 88 days

• Screening: 3 to 28 days
• Treatment: 1 day
• Follow-up: 57± 3 days after dosing

Inclusion criteria

• Male or female Japanese who are 20 to 65 years of age
• Diagnosis of rheumatoid arthritis (RA) ≥ 3 months duration
• 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

• Autoimmune or inflammatory systemic or localized joint disease other than RA
• Women of a positive pregnancy test
• Latent or active tuberculosis
• Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist
• 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
• Received any live, attenuated vaccine within 3 months prior to the randomization visit (eg, varicella-zoster, oral polio, rubella vaccines)
• 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.
• Received surgery within 4 weeks prior to the screening visit or planned surgery during the study
• 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.