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Status unknownNCT03101800Updated Aug 15, 2018

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

A Phase 3 interventional study of Azathioprine and Allopurinol and Azathioprine in Colitis, Ulcerative and Colitis Ulcerative Exacerbation, sponsored by Hvidovre University Hospital. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-08-15.

Sponsored by Hvidovre University Hospital · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the detailed description

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

02

Conditions studied

  • Colitis, Ulcerative
  • Colitis Ulcerative Exacerbation

Keywords

  • Azathioprine
  • Allopurinol
  • Antimetabolites
  • Ulcerative Colitis
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In context

Colitis

1,073 studies on the registry are indexed under Colitis; 133 are open to participants now.

This study's planned enrollment of 84 is above the median of 60 across 771 interventional studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Hvidovre University Hospital is the lead sponsor of 295 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    Azathioprine and Allopurinol

    Drug: Azathioprine and Allopurinol

  • Active comparator
    Azathioprine

    Drug: Azathioprine

Interventions

  • DrugAzathioprine and Allopurinol

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

  • DrugAzathioprine

    Standard weight based azathioprine dosage

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What researchers measure

Primary outcomes

  1. Complete remission

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

    Time frame: 52 weeks

Secondary outcomes

  1. Time to remission

    Time frame: 52 weeks

  2. Clinical response

    defined as a Mayo score between ≤1 to \< 3

    Time frame: 52 weeks

  3. Endoscopic remission

    defined as a Mayo subscore of 0

    Time frame: 52 weeks

  4. Fecal calprotectin

    Time frame: 52 weeks

  5. Histological mucosal healing

    Time frame: 52 weeks

  6. Quality of life (SIBDQ)

    Using Inflammatory Bowel Disease Questionnaire Quality of life (SIBDQ)

    Time frame: 52 weeks

  7. Quality of life (SHS)

    Using the Short health scale (SHS)

    Time frame: 52 weeks

  8. Correlation between 6ThioGuanineNucleotiude (6TGN) and clinical mayo score

    Time frame: From week 6 to week 52

  9. Correlation between 6TGN and standard blood tests

    Time frame: From week 6 to week 52

  10. Correlation between 6TGN and fecal calprotectin

    Time frame: From week 6 to week 52

  11. Correlation between 6TGN endoscopic mayo score

    Time frame: From week 6 to week 52

  12. Correlation between 6TGN and histological mucosal healing

    Time frame: From week 6 to week 52

  13. Adverse events

    Time frame: 52 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 35274092 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03101800
Lead sponsor
Hvidovre University Hospital
Collaborators
Aalborg University Hospital, Zealand University Hospital, University of Copenhagen, Odense University Hospital, Aarhus University Hospital, Viborg Regional Hospital, Vejle Hospital, Sydvestjysk Hospital Esbjerg
Responsible party
Sandra Bohn Thomsen (MD, Ph.D. candidate, Hvidovre University Hospital) — Principal investigator
First posted
Apr 5, 2017
Start date
Dec 14, 2016
Primary completion
Nov 14, 2019 (estimated)
Completion
Dec 14, 2019 (estimated)
Last update
Aug 15, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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