ow-dose azathioprine and allopurinol versus azathioprine monotherapy for patients with ulcerative colitis: protocol for an investigator initiated, open, multicentre, parallel arm, randomised controlled trial - AAUC

Hvidovre Hospital0 个研究点目标入组 84 人开始时间: 2016年6月21日最近更新: 2021年10月12日

试验速览

暂无简介。

•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

发起方