Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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.
Sites / Locations
- Investigational Site Number 392001
- Investigational Site Number 392002
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Sarilumab (SAR153191, REGN88) Dose 1
Sarilumab (SAR153191, REGN88) Dose 2
Sarilumab (SAR153191, REGN88) Dose 3
Sarilumab (SAR153191, REGN88) Dose 4
Placebo Dose 5
First dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Second dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Third dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Fourth dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
Placebo to match Sarilumab (SAR153191, REGN88) in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy