CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 61 enrolled
Drug / intervention
Infliximab +1 moredrug
Likely dose
Infliximab 3 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01313520
NCT01313520Phase 2Completed
CompareCT.gov

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)

Merck Sharp & Dohme LLC·interventional·Posted Mar 11, 2011·Updated May 10, 2017

In Brief

A Phase 2 clinical trial evaluating Infliximab and Placebo for Arthritis, Rheumatoid. Completed, enrolled 61 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2011
Enrollment StartMar 1, 2011
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 15.3 years ago

Interventions

Infliximabdrug

3 mg/kg of Infliximab at Weeks 0, 2, 6, 14 via intravenous infusion

Placebodrug

250 mL of 0.9% sodium chloride at Weeks 0, 2, 6, 14 via intravenous infusion