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.
Investigator initiated, multicentre, parallel arm, open, randomised controlled trial with blinded assessment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
84
Low dose Azathioprine in combination with allopurinol 100 mg for 1 year
Standard weight based azathioprine dosage
Hvidovre university hospital
Hvidovre, Denmark
RECRUITINGComplete remission
Steroid- and biologic treatment free remission defined as total Mayo score ≤1 without rectal bleeding.
Time frame: 52 weeks
Time to remission
Time frame: 52 weeks
Clinical response
defined as a Mayo score between ≤1 to \< 3
Time frame: 52 weeks
Endoscopic remission
defined as a Mayo subscore of 0
Time frame: 52 weeks
Fecal calprotectin
Time frame: 52 weeks
Histological mucosal healing
Time frame: 52 weeks
Quality of life (SIBDQ)
Using Inflammatory Bowel Disease Questionnaire Quality of life (SIBDQ)
Time frame: 52 weeks
Quality of life (SHS)
Using the Short health scale (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
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