drugset / Trial / NCT01017367

Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (RA)

NCT01017367 ↗

Phase 2 Completed 70 enrolled Bristol-Myers Squibb
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to: 1. determine the American College of Rheumatology (ACR) 20 response rate at Day 85 in subjects with active rheumatoid arthritis(RA) administered MDX 1100 with methotrexate (MTX); and 2. determine the tolerability and safety of multiple doses of MDX-1100 in combination with MTX in subjects with active RA.

Timeline

Start
2008-02
Primary completion
2009-01
Completion
2009-05

Outcome

Met primary endpoint

paper The ACR20 response rate was significantly higher among MDX-1100-treated patients than among placebo-treated patients (54% versus 17%; P = 0.0024). PMID 22147649 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Eldelumab Monoclonal antibody 10 mg/kg Intravenous

Indications