Effect of azathioprine and allopurinol compared to azaothioprine monotherapy in ulcerative colitis
- Conditions
- lcerative ColitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2016-002433-30-DK
- Lead Sponsor
- Hvidovre Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 84
•Age 18 - 80 years at the time of inclusion
•Willing to comply with all trial procedures and 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-TNFa.
•A sigmoidoscopy showing active inflammation in the present disease flare
•Negative stool test for pathogen bacteria incl. C. difficile
•Willing to give informed consent;
•Normal TPMT genotype. TPMT can be measured as genotype or phenotype. A normal TPMT genotype is ‘wild type’. A normal TPMT phenotype is > 14 U/ml ery
• Oral 5-ASA dose stable for two weeks
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14
•Kidney disease with a GRF < 50.
•Persistent alanine aminotransferase (ALT) twice above upper limit of the normal range;
•Infectious diarrhoea.
•Participation in other interventional clinical trials.
•Pregnancy or breastfeeding
•Previous or current treatment with other biologics than anti-TNFa
•Not being able to comply with the study, assessed by investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the beneficial and harmful effects of low dose azathioprine and allopurinol versus standard azathioprine monotherapy for patients with ulcerative colitis;Secondary Objective: •Time to remission (defined as described above)<br>•Clinical response after 52 weeks (defined as a Mayo score between =1 to < 3)<br>•Endoscopic remission after 52 weeks (defined as a Mayo subscore of 0)<br>•Fecal calprotectin levels after 52 weeks.<br>•Quality of life after 26 and 52 weeks using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) and short health scale (SHS).<br>•Correlation between E-6TGN and clinical, laboratory, endoscopic and histological indices.<br>•Histological mucosal healing after 52 weeks.<br>•Adverse events <br>;Primary end point(s): Steroid and biologic treatment free remission defined as total Mayo score =1without rectal bleeding;Timepoint(s) of evaluation of this end point: at 52 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Time to remission (defined as described above)<br>•Clinical response after 52 weeks (defined as a Mayo score between =1 to < 3)<br>•Endoscopic remission after 52 weeks (defined as a Mayo subscore of 0)<br>•Fecal calprotectin levels after 52 weeks.<br>•Quality of life after 26 and 52 weeks. We will assess the quality of life using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) and short health scale (SHS)<br>•Histological mucosal healing after 52 weeks.<br>•Correlation between E-6TGN and clinical, laboratory, endoscopic and histological indices after 52 weeks<br>•Adverse events ;Timepoint(s) of evaluation of this end point: At week 52