Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Imurel
Pharmaceutical Form: Tablet
INN or Proposed INN: Azathioprine
CAS Number: 446-86-6
Other descriptive name: AZATHIOPRINE
Concentration unit: mg milligram(s)
Concentration type: range
Sponsors
Hvidovre Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) • Clinical response after 52 weeks (defined as a Mayo score between =1 to < 3) • Endoscopic remission after 52 weeks (defined as a Mayo subscore of 0) • Fecal calprotectin levels after 52 weeks. • Quality of life after 26 and 52 weeks using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) and short health scale (SHS). • Correlation between E-6TGN and clinical, laboratory, endoscopic and histological indices. • Histological mucosal healing after 52 weeks. • Adverse events ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time to remission (defined as described above) • Clinical response after 52 weeks (defined as a Mayo score between =1 to < 3) • Endoscopic remission after 52 weeks (defined as a Mayo subscore of 0) • Fecal calprotectin levels after 52 weeks. • 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) • Histological mucosal healing after 52 weeks. • Correlation between E-6TGN and clinical, laboratory, endoscopic and histological indices after 52 weeks • Adverse events ;Timepoint(s) of evaluation of this end point: At week 52 | — |
Countries
Denmark
Contacts
Public ContactAnette Mertz Nielsen
Hvidovre Hospital
Outcome results
None listed