Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732)

Phase 3 Terminated 9 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a double-blind, double-dummy, prednisolone-controlled, multi-center, randomized, parallel-group clinical study to evaluate the therapeutic efficacy of repeated infliximab infusions in order to maintain Crohn's disease remission at the end of the study.

Timeline

Start: 2003-11-01
Primary completion: 2005-01-01
Completion: 2005-01-01

Publications

Results Leombruno JP, Nguyen GC, Grootendorst P, Juurlink D, Einarson T. Hospitalization and surgical rates in patients with Crohn's disease treated with infliximab: a matched analysis. Pharmacoepidemiol Drug Saf. 2011 Aug;20(8):838-48. doi: 10.1002/pds.2132. Epub 2011 Jun 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Infliximab	Monoclonal antibody	5 mg/kg	Other
Comparator	Prednisolone	Other / unclassified	20 mg	Oral
Comparator	Azathioprine	Small molecule	2 mg/kg	Oral

Efficacy of Infliximab in the Treatment of Patients Affected by Corticodependent Crohn's Disease (P02732)

Summary

Timeline

Publications

Drugs

Indications