A Multicenter Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease (CD) Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence

NCT01190839 ↗

Phase 3 Terminated 297 enrolled Janssen Biotech, Inc.

RandomizedParallel-groupQuadruple-blindPrevention

Summary

REMICADE (infliximab) is a drug used to treat active Crohn's disease and is being tested in an experiment to see if it may be useful in preventing relapse of Crohn's disease after surgical resection. This study will compare the effects (both good and bad) of REMICADE (infliximab) to those of placebo. Placebo looks like the drug being studied but has no active ingredients.

Timeline

Start: 2010-11
Primary completion: 2014-12
Completion: 2014-12

Outcome

Missed primary endpoint

Stopped: “Study is terminated as per Sponsor's Decision.”

paper Infliximab is not superior to placebo in preventing clinical recurrence after CD-related resection. PMID 26946343 ↗

Publications

Regueiro M, Feagan BG, Zou B, Johanns J, Blank MA, Chevrier M, Plevy S, Popp J, Cornillie FJ, Lukas M, Danese S, Gionchetti P, Hanauer SB, Reinisch W, Sandborn WJ, Sorrentino D, Rutgeerts P; PREVENT Study Group. Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn's Disease After Ileocolonic Resection. Gastroenterology. 2016 Jun;150(7):1568-1578. doi: 10.1053/j.gastro.2016.02.072. Epub 2016 Mar 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Infliximab	Monoclonal antibody	5 mg/kg	Intravenous
Subject	Infliximab	Monoclonal antibody	10 mg/kg	Intravenous