Colitis, Ulcerative Clinical Trial
Official title:
Efficacy of Optimized Thiopurine Therapy in Ulcerative Colitis (OPTIC)
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.
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.
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