Mercaptopurine Therapy in Ulcerative Colitis
OPTIC
Efficacy of Optimized Thiopurine Therapy in Ulcerative Colitis (OPTIC)
1 other identifier
interventional
136
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2016
Longer than P75 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2016
CompletedFirst Posted
Study publicly available on registry
September 22, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedJanuary 7, 2020
January 1, 2020
5.5 years
September 9, 2016
January 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical and endoscopic remission
Defined as a SCCAI-score ≤ 4, a UCEIS-score ≤ 3 and a total Mayo score ≤ 2, with no individual subscore \>1.
After 52 weeks of treatment
Secondary Outcomes (9)
(Serious) Adverse Events
Continue during 52 weeks of treatment
Leukocyte counts
Every 6 weeks during 52 weeks of treatment
Liver function tests
Every 6-12 weeks during 52 weeks of treatment
Occurrence of subjective thiopurine intolerance
Every 6-12 weeks during 52 weeks of treatment
6-TGN levels
Every 6-12 weeks during 52 weeks of treatment
- +4 more secondary outcomes
Other Outcomes (1)
Disease specific quality of life
Every 3 months during 52 weeks of treatment
Study Arms (2)
Mercaptopurine (Purinethol)
ACTIVE COMPARATORMercaptopurine (Purinethol),1-1.5 mg/kg/day oral, 52 weeks \& Prednisone, 40 mg/day oral, 2 weeks, followed by fixed tapering over 6 weeks OR budesonide (cortiment) 9 mg/day during 8 weeks \& Mesalamine, 2 g/day oral, 52 weeks.
Placebo
PLACEBO COMPARATORPlacebo, 1-1.5 mg/kg/day, 52 weeks \& Prednisone, 40 mg/day oral, 2 weeks, followed by fixed tapering over 6 weeks OR budesonide (cortiment) 9 mg/day during 8 weeks \& Mesalamine, 2 g/day oral, 52 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of UC by endoscopy and histopathology
- Patients between 18 and 80 years of age
- Active disease, despite oral treatment with at least 2g/day 5-ASA
- Treatment with oral corticosteroids is required
You may not qualify if:
- Prior treatment with thiopurines
- Prior treatment with biologics (e.g. anti-TNF agents and vedolizumab)
- Current pregnancy (a pregnancy test will be performed if necessary according to the treating physician)
- Chronic Obstructive Pulmonary Disease (COPD)
- Acute coronary heart disease
- (Bacterial) gastroenteritis has to be treated first
- Coagulation disorders
- Active malignancy
- History of colonic dysplasia/cancer
- Extensive colonic resection, i.e. subtotal colectomy with \<15 cm colon in situ
- Concomitant therapy with drugs interfering with MP metabolism, like allopurinol, ribavirin or anti-epileptics.
- Known systemic fungal infections or parasitic infections have to be treated first
- Known duodenal or ventricular ulcus
- Positive tuberculosis screen (when a screening is performed at the discretion of the treating physician)
- Active hepatitis B virus or hepatitis C virus infection defined as a positive anti-HCV, HBsAg and/or anti-HBcore screening.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Flevoziekenhuis
Almere Stad, Netherlands
Meander MC
Amersfoort, 3813 TZ, Netherlands
Amsterdam UMC, location VUMC
Amsterdam, 1081 HZ, Netherlands
OLVG Oost
Amsterdam, 1090 HM, Netherlands
Amsterdam UMC, location AMC
Amsterdam, 1105AZ, Netherlands
Amstelland Hospital
Amsterdam, Netherlands
Tergooi Hospital
Hilversum, 1213 XZ, Netherlands
Westfriesgasthuis
Hoorn, Netherlands
St. Antonius Hospital
Nieuwegein, 3435 CM, Netherlands
Sint Franciscus Gasthuis
Rotterdam, Netherlands
MC Haaglanden
The Hague, 2512 VA, Netherlands
Related Publications (1)
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.
PMID: 40013523DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Löwenberg, MD, PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Gastroenterologist
Study Record Dates
First Submitted
September 9, 2016
First Posted
September 22, 2016
Study Start
November 1, 2016
Primary Completion
April 30, 2022
Study Completion
April 30, 2022
Last Updated
January 7, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share