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Infliximab Effects on MRI in RA
NCT01313520Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2011
- Primary completion
- Mar 2012
- Sponsor
- Merck & Co.
- Modality
- Monoclonal Antibodies
- Drugs
- infliximab
- Conditions
- rheumatoid arthritis (RA)
01
Overview
Phase 2, randomised, double-blind trial in rheumatoid arthritis (RA) comparing Infliximab Arm with Placebo Arm (2 arms). Primary endpoint: Volume Transfer Rate From Blood Plasma to Enhancing Synovium at 14 weeks. Started Mar 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Infliximab Arm
Infliximab 3 mg/kg IV + Methotrexate
Placebo Arm
Placebo IV + Methotrexate
03
Who it enrols
Adult patients with active rheumatoid arthritis for at least 6 months, on stable methotrexate, with evidence of synovitis on MRI.
04
Endpoints
Primary
Volume Transfer Rate From Blood Plasma to Enhancing Synovium
Secondary
American College of Rheumatology 20% Improvement
American College of Rheumatology 50% Improvement
Composite of DAS28-CRP and Ktrans
Composite of DAS28-CRP and RAMRIS Synovitis + Osteitis
05
Results
Primary endpoints met
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