Overview

Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers

Status:
Terminated
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Treatments:
Antibodies, Monoclonal
Folic Acid
Golimumab
Leucovorin
Levoleucovorin
Methotrexate