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

August 14, 2018 updated by: Sandra Bohn Thomsen, Hvidovre University Hospital

Low-dose Azathioprine and Allopurinol- Versus Azathioprine Monotherapy in Patients With Ulcerative Colitis: An Investigator-initiated, Open, Multicentre, Parallel-arm, Randomised Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Azathioprine and Allopurinol
Drug: Azathioprine and Allopurinol
Low dose Azathioprine in combination with allopurinol 100 mg for 1 year
Active Comparator: Azathioprine
Drug: Azathioprine
Standard weight based azathioprine dosage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete remission
Time Frame: 52 weeks
Steroid- and biologic treatment free remission defined as total Mayo score ≤1 without rectal bleeding.
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 52 weeks
52 weeks
Time to remission
Time Frame: 52 weeks
52 weeks
Clinical response
Time Frame: 52 weeks
defined as a Mayo score between ≤1 to < 3
52 weeks
Endoscopic remission
Time Frame: 52 weeks
defined as a Mayo subscore of 0
52 weeks
Fecal calprotectin
Time Frame: 52 weeks
52 weeks
Histological mucosal healing
Time Frame: 52 weeks
52 weeks
Quality of life (SIBDQ)
Time Frame: 52 weeks
Using Inflammatory Bowel Disease Questionnaire Quality of life (SIBDQ)
52 weeks
Quality of life (SHS)
Time Frame: 52 weeks
Using the Short health scale (SHS)
52 weeks
Correlation between 6ThioGuanineNucleotiude (6TGN) and clinical mayo score
Time Frame: From week 6 to week 52
From week 6 to week 52
Correlation between 6TGN and standard blood tests
Time Frame: From week 6 to week 52
From week 6 to week 52
Correlation between 6TGN and fecal calprotectin
Time Frame: From week 6 to week 52
From week 6 to week 52
Correlation between 6TGN endoscopic mayo score
Time Frame: From week 6 to week 52
From week 6 to week 52
Correlation between 6TGN and histological mucosal healing
Time Frame: From week 6 to week 52
From week 6 to week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Collaborators

Odense University Hospital
Zealand University Hospital
Aarhus University Hospital
University of Copenhagen
Vejle Hospital
Aalborg University Hospital
Viborg Regional Hospital
Sydvestjysk Hospital Esbjerg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2016

Primary Completion (Anticipated)

November 14, 2019

Study Completion (Anticipated)

December 14, 2019

Study Registration Dates

First Submitted

January 27, 2017

First Submitted That Met QC Criteria

March 29, 2017

First Posted (Actual)

April 5, 2017

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAUC Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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