Conditions: Arthritis, Rheumatoid
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 61
Healthy volunteers: no

Brief summary:
This is a study to compare the effect of infliximab versus placebo on synovial inflammation as measured by dynamic contrast enhanced (DCE)-MRI of one wrist. The primary hypothesis is that over 14 weeks of therapy, the change from baseline in the volume transfer rate in enhancing synovium is larger due to treatment with infliximab than with placebo.

Detailed description:

Arms:
arm 1: 3 mg/kg of Infliximab intravenous infusion arm 2: saline via intravenous infusion

Interventions: intervention 1: Infliximab intervention 2: Placebo
Intervention descriptions: intervention 1: 3 mg/kg of Infliximab at Weeks 0, 2, 6, 14 via intravenous infusion intervention 2: 250 mL of 0.9% sodium chloride at Weeks 0, 2, 6, 14 via intravenous infusion

Protocol document: