Two Therapeutic Strategies for the Maintenance of Remission in Patients With Ulcerative Colitis

Phase 4 Unknown 100 enrolled Istituto Clinico Humanitas Agenzia Italiana del Farmaco · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Ulcerative colitis patients treated with Infliximab (IFX) in deep remission after at least 12 months of treatment will be randomized to continue IFX or to stop IFX and start Azathioprine (AZA). Each patient will be followed for 12 months.

Timeline

Start: 2017-05-08
Primary completion: 2019-10-03
Completion: 2020-04-03

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	—
Subject	Azathioprine	Small molecule	2.5 mg/kg	—
Comparator	Infliximab	Monoclonal antibody	5 mg/kg	—

Two Therapeutic Strategies for the Maintenance of Remission in Patients With Ulcerative Colitis

Summary

Timeline

Publications

Drugs

Indications