Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553)

Phase 3 Terminated 28 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupOpen-labelTreatment

Summary

This study will be performed to compare the efficacy and safety of the classical "Step-Up" approach for treatment of moderate-to-severe active ulcerative colitis using oral prednisolone + oral 5-aminosalicylic acid (5-ASA) or oral prednisolone + oral azathioprine (AZA) with a more intensive and early "Top-Hold" approach with intravenous infliximab (5 mg/kg) administered at Weeks 0, 2, and 6 and 8 weeks thereafter.

Timeline

Start: 2009-11
Primary completion: 2012-03
Completion: 2012-03

Publications

Hasskamp J, Meinhardt C, Patton PH, Timmer A. Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD000478. doi: 10.1002/14651858.CD000478.pub5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azathioprine	Small molecule	2 mg/kg	Oral
Subject	Azathioprine	Small molecule	2.5 mg/kg	Oral
Subject	Infliximab	Monoclonal antibody	5 mg/kg	Intravenous
Comparator	Mesalamine	Small molecule	2 g	Oral
Subject	Prednisolone	Other / unclassified	1 mg/kg	Oral
Subject	Prednisolone	Other / unclassified	40 mg	Oral

Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553)

Summary

Timeline

Publications

Drugs

Indications