NCT03101800

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2016

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

December 14, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 27, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2019

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

2.9 years

First QC Date

January 27, 2017

Last Update Submit

August 14, 2018

Conditions

Colitis, UlcerativeColitis Ulcerative Exacerbation

Keywords

AzathioprineAllopurinolAntimetabolitesUlcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Complete remission

    Steroid- and biologic treatment free remission defined as total Mayo score ≤1 without rectal bleeding.

    52 weeks

Secondary Outcomes (13)

  • Time to remission

    52 weeks

  • Clinical response

    52 weeks

  • Endoscopic remission

    52 weeks

  • Fecal calprotectin

    52 weeks

  • Histological mucosal healing

    52 weeks

  • +8 more secondary outcomes

Study Arms (2)

Azathioprine and Allopurinol

EXPERIMENTAL
Drug: Azathioprine and Allopurinol

Azathioprine

ACTIVE COMPARATOR
Drug: Azathioprine

Interventions

Azathioprine and AllopurinolDRUG

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

Azathioprine and Allopurinol
AzathioprineDRUG

Standard weight based azathioprine dosage

Azathioprine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre university hospital

Hvidovre, 2650, Denmark

RECRUITING

Related Publications (2)

  • 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

  • Kiszka-Kanowitz M, Theede K, Thomsen SB, Bjerrum JT, Brynskov J, Gottschalck IB, Akimenko E, Hilsted KL, Neumann A, Wildt S, Larsen L, Munk JK, Ibsen PH, Janjua HGR, Gluud LL, Mertz-Nielsen A. Low-dose azathioprine and allopurinol versus azathioprine monotherapy in patients with ulcerative colitis (AAUC): An investigator-initiated, open, multicenter, parallel-arm, randomised controlled trial. EClinicalMedicine. 2022 Mar 5;45:101332. doi: 10.1016/j.eclinm.2022.101332. eCollection 2022 Mar.

    PMID: 35274092DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

AzathioprineAllopurinol

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

ThionucleosidesSulfur CompoundsOrganic ChemicalsMercaptopurinePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D. candidate

Study Record Dates

First Submitted

January 27, 2017

First Posted

April 5, 2017

Study Start

December 14, 2016

Primary Completion

November 14, 2019

Study Completion

December 14, 2019

Last Updated

August 15, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)