NCT01313520

A Study to Evaluate the Effectiveness of Infliximab and Changes in Hand and Wrist Magnetic Resonance Imaging (MRI) in Participants With Active Rheumatoid Arthritis (RA) (P08136)

A Randomized Clinical Trial to Study the Effects of Infliximab on Clinical Efficacy and Hand and Wrist Magnetic Resonance Imaging (MRI) in Patients With Active Rheumatoid Arthritis (RA)(Protocol No. P08136)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Infliximab	3 mg/kg of Infliximab at Weeks 0, 2, 6, 14 via intravenous infusion
DRUG	Placebo	250 mL of 0.9% sodium chloride at Weeks 0, 2, 6, 14 via intravenous infusion

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-03-11
• Last updated: 2017-05-10
• Results posted: 2013-07-08