Beneficial and Harmful Effects of Azathioprine and Allopurinol Versus Standard Azathioprine Therapy for Patients With Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-14

Study Completion Date

2019-12-14

Brief Summary

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Azathioprine is considered first line immunomodulatory therapy for patients with ulcerative colitis. Up to 50% are treatment failures or experience adverse events leading to treatment withdrawal. Recent evidence suggests that the combination of allopurinol and low dose azathioprine increases the proportion of treatment responders and reduce the risk of adverse events.

Objectives: To evaluate the beneficial and harmful effects of low dose azathioprine and allopurinol versus standard azathioprine monotherapy in patients with ulcerative colitis.

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Detailed Description

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Investigator initiated, multicentre, parallel arm, open, randomised controlled trial with blinded assessment

Conditions

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Colitis, Ulcerative Colitis Ulcerative Exacerbation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Azathioprine and Allopurinol

Group Type EXPERIMENTAL

Azathioprine and Allopurinol

Intervention Type DRUG

Low dose Azathioprine in combination with allopurinol 100 mg for 1 year

Azathioprine

Group Type ACTIVE_COMPARATOR

Azathioprine

Intervention Type DRUG

Standard weight based azathioprine dosage

Interventions

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Azathioprine and Allopurinol

Low dose Azathioprine in combination with allopurinol 100 mg for 1 year

Intervention Type DRUG

Azathioprine

Standard weight based azathioprine dosage

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Willingness to comply with all trial procedures and being available for the duration of the trial.
* Clinically and histologically verified ulcerative colitis eligible for treatment with thiopurines due to steroid dependence (failure to taper steroid or starting a second course of systemic steroids within 1 year) or patients with the need for rescue therapy with anti-TumorNecrosisFactorα (anti-TNFα)
* A sigmoidoscopy or colonoscopy showing active inflammation during the present disease flare
* Negative stool test for pathogen bacteria incl. Clostridium difficile
* Informed consent.
* Normal TPMT genotype (homozygous wild-type).
* Oral 5-Asa dose stable for 2 weeks

Exclusion Criteria

* Kidney disease with a GlomerularFiltration Rate (GFR) \< 50 ml/min.
* Persistent alanine aminotransferase U/L (ALT) twice above upper limit of the normal range.
* Participation in other interventional clinical trials.
* Pregnancy or breastfeeding.
* Previous thiopurin treatment.
* Previous or current treatment with other biologics than anti-TNFα
* Not being able to comply with the study, assessed by investigator

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No