drugset / Trial / NCT02373202
A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Primary Objective: To document the long-term safety of sarilumab added to non-methotrexate (non-MTX) disease-modifying antirheumatic drugs (DMARDs) or as monotherapy. Secondary Objective: To document the long term efficacy of sarilumab added to non-MTX DMARDs or as monotherapy.
Timeline
- Start
- 2015-02
- Primary completion
- 2016-11
- Completion
- 2016-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sarilumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Sarilumab | Monoclonal antibody | 200 mg | Subcutaneous |
| Background | Bucillamine | Small molecule | — | Oral |
| Background | Leflunomide | Small molecule | — | Oral |
| Background | Mizoribine | Small molecule | — | Oral |
| Background | Sulfasalazine | Small molecule | — | Oral |
| Background | Tacrolimus | Small molecule | — | Oral |