drugset / Trial / NCT01217814
Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers
RandomizedParallel-groupTriple-blindTreatment
Summary
Primary Objective: \- To demonstrate that sarilumab (SAR153191/REGN88) on top of methotrexate (MTX) was superior in efficacy to placebo for the relief of signs and symptoms of rheumatoid arthritis (RA), in participants with active RA who had failed up to 2 tumor necrosis factor-alpha (TNF-α) antagonists. Secondary Objectives: * To assess the safety of sarilumab; * To document the pharmacokinetic profile of sarilumab.
Timeline
- Start
- 2010-11
- Primary completion
- 2011-09
- Completion
- 2011-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Golimumab | Monoclonal antibody | 50 mg | Subcutaneous |
| Subject | Sarilumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Background | Folic/folinic acid | Unknown | — | Oral |
| Background | Methotrexate | Small molecule | 15 mg | Oral |
| Background | Methotrexate | Small molecule | 25 mg | Oral |