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MPC-300-IV in Biologic Refractory Rheumatoid Arthritis
NCT01851070Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2013
- Primary completion
- May 2016
- Countries
- 2
- Sponsor
- Mesoblast Ltd
- Drugs
- rexlemestrocel-l
- Conditions
- rheumatoid arthritis (RA)
01
Overview
Phase 2, randomised, double-blind trial of rexlemestrocel-l in rheumatoid arthritis (RA) (3 arms), sponsored by Mesoblast Ltd. Primary endpoint: Safety and Tolerability at 12 weeks. Started Jul 2013; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Placebo + MTX
Normal Saline infusion + stable Methotrexate
1M MPCs/kg + MTX
1.0 million cells/kg rexlemestrocel-L + stable Methotrexate
2M MPCs/kg + MTX
2.0 million cells/kg rexlemestrocel-L + stable Methotrexate
03
Who it enrols
Adults with active rheumatoid arthritis (positive for RF or anti-CCP) who have failed at least one TNF-alpha inhibitor and are on a stable dose of methotrexate.
04
Endpoints
Primary
Safety and Tolerability
Secondary
American College of Rheumatology 20% Improvement
American College of Rheumatology 50% Improvement
American College of Rheumatology 70% Improvement
Disease Activity Score 28
Health Assessment Questionnaire Disability Index
Long-term Safety and Efficacy
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