drugset / Trial / NCT01850680
Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Primary Objective: To assess the safety and tolerability of a single dose of subcutaneously administered sarilumab in Japanese patients with rheumatoid arthritis (RA) who are receiving concomitant treatment with methotrexate. Secondary Objective: To assess the pharmacokinetic profile of a single subcutaneous (SC) dose of sarilumab in Japanese RA patients.
Timeline
- Start
- 2013-04
- Primary completion
- 2013-12
- Completion
- 2013-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sarilumab | Monoclonal antibody | — | Subcutaneous |
| Background | Methotrexate | Small molecule | — | Oral |
| Background | folic acid | Other / unclassified | — | Oral |