NCT02910245

Mercaptopurine Therapy in Ulcerative Colitis

Efficacy of Optimized Thiopurine Therapy in Ulcerative Colitis (OPTIC)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subjects will receive treatment with oral prednisone 40 mg/day for 2 weeks, followed by fixed tapering over 6 weeks. Half of the subjects will be randomized to concomitant 6-MP 1-1.5 mg/kg/day and half will receive concomitant placebo treatment. During the entire course of the trial all subjects will receive maintenance treatment with 5-ASA in an oral dose of at least 2 gram per day. Subjects will be subjected to one colonoscopy at baseline and one sigmoidoscopy in week 52 in order to assess endoscopic disease activity. Data will be collected using electronic case report forms (eCRF) with Castor EDC. Quality and data validation procedures will be applied to ensure the validity and accuracy of the clinical database. Monitoring of the study will be done according to the GCP guidelines and following a monitoring plan. The financier of the study, ZonMw Goed Gebruik Geneesmiddelen, has the right to perform an audit if seen necessary.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	Mercaptopurine (Purinethol)
DRUG	Placebo
DRUG	Mesalamine
DRUG	Prednisone

Timeline

• Start date: 2016-11-01
• Primary completion: 2022-04-30
• Completion: 2022-04-30
• First posted: 2016-09-22
• Last updated: 2020-01-07

Locations

12 sites across 1 country: Netherlands