drugset / Trial / NCT01851070

A Multi-center Study a Single IV Infusion of Allogeneic MPCs in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNFα Inhibitor

NCT01851070

Phase 2 Completed 48 enrolled Mesoblast, Inc. PPD Development, LP · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

Study is a double-blind, randomized, placebo controlled, dose escalating study. The primary objective of this study is to evaluate the safety, tolerability and feasibility of a single intravenous infusion of allogeneic mesenchymal precursor cells (MPCs) compared to placebo at 12 weeks post-infusion in the treatment of patients with active rheumatoid arthritis (RA) who have received methotrexate +/- other DMARDs for at least 6 months prior to screening and who have had an incomplete response to at least one TNF-alpha inhibitor.

Timeline

Start
2013-07
Primary completion
2016-05
Completion
2017-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rexlemestrocel-L Cell therapy 1 cells/kg Intravenous
Comparator Rexlemestrocel-L Cell therapy 2 cells/kg Intravenous

Indications