Colitis, UlcerativePhase 3NCT03101800
Beneficial and Harmful Effects of Azathioprine and Allopurinol Versus Standard Azathioprine Therapy for Patients With Ulcerative Colitis
A Phase 3 study testing Azathioprine and Allopurinol and Azathioprine in people with Colitis, Ulcerative and Colitis Ulcerative Exacerbation, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colitis, Ulcerative, Colitis Ulcerative Exacerbation
- What is being tested?
- Azathioprine and Allopurinol and Azathioprine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Dec 2016to 14 Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Hvidovre university hospital
Hvidovre, 2650
Sandra B Thomsen, +4538626540, sandra.bohn.thomsen@regionh.dk
About this study
Official title: 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.
Read the detailed description
Investigator initiated, multicentre, parallel arm, open, randomised controlled trial with blinded assessment
- Being tested
- Azathioprine and Allopurinol, Azathioprine
- Keywords
- Azathioprine, Allopurinol, Antimetabolites, Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azathioprine and AllopurinolDrug
Low dose Azathioprine in combination with allopurinol 100 mg for 1 year
AzathioprineDrug
Standard weight based azathioprine dosage
| Study group | Role | What they receive |
|---|---|---|
| Azathioprine and Allopurinol | Experimental | Not described Receives: Drug: Azathioprine and Allopurinol |
| Azathioprine | Active comparator | Not described Receives: Drug: Azathioprine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission
Steroid- and biologic treatment free remission defined as total Mayo score ≤1 without rectal bleeding.
Measured: 52 weeks
Secondary outcomes (13)
Time to remission
Measured: 52 weeks
Clinical response
defined as a Mayo score between ≤1 to < 3
Measured: 52 weeks
Endoscopic remission
defined as a Mayo subscore of 0
Measured: 52 weeks
Fecal calprotectin
Measured: 52 weeks
Histological mucosal healing
Measured: 52 weeks
Quality of life (SIBDQ)
Using Inflammatory Bowel Disease Questionnaire Quality of life (SIBDQ)
Measured: 52 weeks
Quality of life (SHS)
Using the Short health scale (SHS)
Measured: 52 weeks
Correlation between 6ThioGuanineNucleotiude (6TGN) and clinical mayo score
Measured: From week 6 to week 52
Correlation between 6TGN and standard blood tests
Measured: From week 6 to week 52
Correlation between 6TGN and fecal calprotectin
Measured: From week 6 to week 52
Correlation between 6TGN endoscopic mayo score
Measured: From week 6 to week 52
Correlation between 6TGN and histological mucosal healing
Measured: From week 6 to week 52
Adverse events
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start14 Dec 2016
- Primary completion14 Nov 2019 (estimated)
- Study completion14 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Sandra Bohn Thomsen, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101800
- Sponsor's protocol ID
- AAUC Study
- Status last verified
- Aug 2018
- First submitted
- 27 Jan 2017
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40013523Kiszka-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
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Azathioprine and Allopurinol- Versus Azathioprine Monotherapy in Patients With Ulcerative Colitis: An Investigator-initiated, Open, Multicentre, Parallel-arm, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03101800
- Acronym / sponsor ID
- AAUC Study
- Keywords
- Azathioprine, Allopurinol, Antimetabolites, Ulcerative Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University Hospital, Zealand University Hospital, University of Copenhagen, Odense University Hospital, Aarhus University Hospital, Viborg Regional Hospital, Vejle Hospital, Sydvestjysk Hospital Esbjerg
- Study start
- 14 Dec 2016 (actual)
- Primary completion
- 14 Nov 2019 (estimated)
- Study completion
- 14 Dec 2019 (estimated)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Investigator initiated, multicentre, parallel arm, open, randomised controlled trial with blinded assessment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azathioprine and Allopurinol | Experimental | Drug: Azathioprine and Allopurinol |
| Azathioprine | Active comparator | Drug: Azathioprine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azathioprine and AllopurinolLow dose Azathioprine in combination with allopurinol 100 mg for 1 year | Drug | Azathioprine and Allopurinol |
| AzathioprineStandard weight based azathioprine dosage | Drug | Azathioprine |
Primary outcome
Complete remission
Time frame: 52 weeks
Steroid- and biologic treatment free remission defined as total Mayo score ≤1 without rectal bleeding.
13 secondary outcomes
Time to remission
Time frame: 52 weeks
Clinical response
Time frame: 52 weeks
Endoscopic remission
Time frame: 52 weeks
Fecal calprotectin
Time frame: 52 weeks
Histological mucosal healing
Time frame: 52 weeks
Quality of life (SIBDQ)
Time frame: 52 weeks
Quality of life (SHS)
Time frame: 52 weeks
Correlation between 6ThioGuanineNucleotiude (6TGN) and clinical mayo score
Time frame: From week 6 to week 52
Correlation between 6TGN and standard blood tests
Time frame: From week 6 to week 52
Correlation between 6TGN and fecal calprotectin
Time frame: From week 6 to week 52
Correlation between 6TGN endoscopic mayo score
Time frame: From week 6 to week 52
Correlation between 6TGN and histological mucosal healing
Time frame: From week 6 to week 52
Adverse events
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Derived from this study: PubMed 40013523Hasskamp 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.
- Derived from this study: PubMed 35274092Kiszka-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azathioprine and Allopurinol and Azathioprine in people with Colitis, Ulcerative and Colitis Ulcerative Exacerbation, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03101800, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018; AzTrials last refreshed its copy on 8 Nov 2026.