Mercaptopurine Therapy in Ulcerative Colitis

Phase 3 Unknown 136 enrolled Academic Medical Center - University of Amsterdam ZonMw: The Netherlands Organisation for Health Research and Development · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This project is a double-blind, randomized, placebo-controlled, multicenter trial in the Netherlands. The aim of this study is to investigate the therapeutic efficacy of optimized 6-mercaptopurine (6-MP) in ulcerative colitis patients. Therapeutic drug monitoring (TDM) will be performed in order to optimize treatment outcomes and objective endoscopic endpoints will be used.

Timeline

Start: 2016-11
Primary completion: 2022-04-30
Completion: 2022-04-30

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
Comparator	MERCAPTOPURINE ANHYDROUS	Small molecule	1 mg/kg	Oral
Comparator	MERCAPTOPURINE ANHYDROUS	Small molecule	1.5 mg/kg	Oral
Comparator	Mesalamine	Small molecule	2 g	Oral
Comparator	Prednisone	Other / unclassified	40 mg	Oral

Mercaptopurine Therapy in Ulcerative Colitis

Summary

Timeline

Publications

Drugs

Indications