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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03101800
• Date of registration: 27/01/2017
• Prospective Registration: No
• Primary sponsor: Hvidovre University Hospital
• Public title: Beneficial and Harmful Effects of Azathioprine and Allopurinol Versus Standard Azathioprine Therapy for Patients With Ulcerative Colitis
• Scientific title: Low-dose Azathioprine and Allopurinol- Versus Azathioprine Monotherapy in Patients With Ulcerative Colitis: An Investigator-initiated, Open, Multicentre, Parallel-arm, Randomised Controlled Trial
• Date of first enrolment: December 14, 2016
• Target sample size: 84
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03101800
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Denmark

Contacts

• Name: Sandra B Thomsen

Key inclusion & exclusion criteria

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-TumorNecrosisFactora (anti-TNFa)

- 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-TNFa

- Not being able to comply with the study, assessed by investigator



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Colitis Ulcerative Exacerbation

Colitis, Ulcerative

Intervention(s)

Drug: Azathioprine and Allopurinol

Drug: Azathioprine

Primary Outcome(s)

Complete remission [Time Frame: 52 weeks]

Secondary Outcome(s)

Clinical response [Time Frame: 52 weeks]

Fecal calprotectin [Time Frame: 52 weeks]

Correlation between 6TGN and standard blood tests [Time Frame: From week 6 to week 52]

Correlation between 6TGN endoscopic mayo score [Time Frame: From week 6 to week 52]

Quality of life (SHS) [Time Frame: 52 weeks]

Adverse events [Time Frame: 52 weeks]

Correlation between 6TGN and fecal calprotectin [Time Frame: From week 6 to week 52]

Correlation between 6ThioGuanineNucleotiude (6TGN) and clinical mayo score [Time Frame: From week 6 to week 52]

Endoscopic remission [Time Frame: 52 weeks]

Correlation between 6TGN and histological mucosal healing [Time Frame: From week 6 to week 52]

Histological mucosal healing [Time Frame: 52 weeks]

Quality of life (SIBDQ) [Time Frame: 52 weeks]

Time to remission [Time Frame: 52 weeks]

Secondary ID(s)

AAUC Study

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Zealand University Hospital

Vejle Hospital

Aalborg University Hospital

Aarhus University Hospital

Regional Hospital Viborg

University of Copenhagen

Odense University Hospital

Sydvestjysk Hospital Esbjerg