drugset / Trial / NCT01764997
An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Primary Objective: To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and MTX in participants with rheumatoid arthritis (RA) and an inadequate response to adalimumab and MTX by evaluation of the Disease Activity Score for 28 joints (DAS28). Secondary Objectives: To assess the signs and symptoms of RA in participants taking sarilumab in combination with MTX. To assess the quality of life of participants with RA taking sarilumab in combination with MTX. To assess the safety and tolerability of sarilumab in combination with MTX in participants with RA.
Timeline
- Start
- 2013-04
- Primary completion
- 2015-01
- Completion
- 2015-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Etanercept | Protein / enzyme biologic | 50 mg | Subcutaneous |
| Subject | Sarilumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Sarilumab | Monoclonal antibody | 200 mg | Subcutaneous |
| Background | Adalimumab | Monoclonal antibody | 40 mg | Subcutaneous |
| Background | Methotrexate | Small molecule | — | — |