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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
136
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
RECRUITINGFlevoziekenhuis
Almere Stad, Netherlands
RECRUITINGClinical and endoscopic remission
Defined as a SCCAI-score ≤ 4, a UCEIS-score ≤ 3 and a total Mayo score ≤ 2, with no individual subscore \>1.
Time frame: After 52 weeks of treatment
(Serious) Adverse Events
Occurrence of (serious) adverse events ((S)AE)
Time frame: Continue during 52 weeks of treatment
Leukocyte counts
Time frame: Every 6 weeks during 52 weeks of treatment
Liver function tests
Time frame: Every 6-12 weeks during 52 weeks of treatment
Occurrence of subjective thiopurine intolerance
Time frame: Every 6-12 weeks during 52 weeks of treatment
6-TGN levels
Time frame: Every 6-12 weeks during 52 weeks of treatment
6-MMP levels
Time frame: Every 6-12 weeks during 52 weeks of treatment
Occurrence of treatment failure
Time frame: Continue during 52 weeks of treatment
Occurrence of upscaling treatment
Occurrence of upscaling treatment to biologicals (anti-TNF agents or vedolizumab)
Time frame: Continue during 52 weeks of treatment
Treatment costs
Budget-impact analysis and cost-utility analysis
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Meander MC
Amersfoort, Netherlands
RECRUITINGAmsterdam UMC, location VUMC
Amsterdam, Netherlands
RECRUITINGOLVG Oost
Amsterdam, Netherlands
RECRUITINGAmsterdam UMC, location AMC
Amsterdam, Netherlands
RECRUITINGAmstelland Hospital
Amsterdam, Netherlands
RECRUITINGTergooi Hospital
Hilversum, Netherlands
RECRUITINGWestfriesgasthuis
Hoorn, Netherlands
RECRUITINGSt. Antonius Hospital
Nieuwegein, Netherlands
RECRUITING...and 2 more locations
Time frame: Every 3 months during 52 weeks of treatment