Patients with inflammatory bowel diseae (Ulcerative colitis or Crohns disease) wh do not responding to first line therapy
Conditions
Interventions
Trade Name: Imurel
Product Name: Azathioprine
Product Code: NA
Pharmaceutical Form: Tablet
Trade Name: Allopurinol
Product Name: Allopurinol
Product Code: NA
Pharmaceutical Form: Tablet
Sponsors
SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years at the time of inclusion, weight between 50 and 100 kg. 2. Willingness to comply with all trial procedures and being available for the duration of the trial. 3. Clinical and histological verified IBD eligible for treatment with thiopurines due to steroid dependence (failure to taper steroid or starting a second course of systemic steroids within one year) or due to the need for thiopurines for other reasons (disease phenotype, i.e post-surgery decision). 4. A written informed consent to participate in the study is signed before any study-related procedures are performed. 5. A normal TPMT activity measurement (>8.9 U/ml RBC) or normal TPMT genotype (*1/*1). 6. Naïve to thiopurine treatment 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Biologic treatment (anti-TNF, vedoluzimab etc) within the last three months prior the study 2. Concurrent participation in another interventional therapy study. 3. Females who are pregnant or breastfeeding 4. Females of childbearing age and potential who are not willing or capable to use acceptable methods of contraception (oral contraceptives, condoms, diaphragms, intrauterine devices) during the entire study and for up to 3 months after the end-of-study evaluation. 5. Male patients who do not use acceptable barrier methods of contraception (condoms) during the entire course of the study and up to 3 months after the end-of-study evaluation. 6. Inability to follow the treatment protocol (as judged by the investigator) 7. Current treatment with Allopurinol. 8. Patients with gout that needs medical treatment. 9. Estimated GFR < 50 ml/ml 10. Persistent alanine aminotransferase U/L (ALT) above upper limit of the normal range.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of low dose azathioprine and allopurinol versus standard azathioprine monotherapy in patients with inflammatory bowel disease. ;Secondary Objective: To compare: Time to remission Steroid and biologic treatment free remission defined as Clinical remission (HBI =4 or SCCAI =2 ) at week 52 and no need for escalation of IBD therapy. Clinical response after week 26 and week 52 (defined as ?3 in HBI or ?3 in SCCAI) The proportion of patients with Fecal calprotectin <200 µg/g (<350 µg/g if Buhlman method is used) at week 26 and 52 . Quality of life after 52 weeks using Short Inflammatory Bowel Disease Questionnaire (SIBDQ) and short health scale (SHS). The proportion of patients who reach therapeutics levels of E-6TGN levels (230-450 pmol/L) at week 6 and week 26. Adverse events defined as any untoward or unfavourable medical occurrence in a human subject Effects on intestinal permeability and microbiota ;Primary end point(s): Steroid and biologic treatment free remission defined as Clinical remission (HBI =4 or SCCAI =2 ) at week 26 and no need for escalation of IBD therapy. ;Timepoint(s) of evaluation of this end point: 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To compare: Time to remission Steroid and biologic treatment free remission defined as Clinical remission (HBI =4 or SCCAI =2 ) at week 52 and no need for escalation of IBD therapy. Clinical response after week 26 and week 52 (defined as ?3 in HBI or ?3 in SCCAI) The proportion of patients with Fecal calprotectin <200 µg/g (<350 µg/g if Buhlman method is used) at week 26 and 52 . Quality of life after 52 weeks using Short Inflammatory Bowel Disease Questionnaire (SIBDQ) and short health scale (SHS). The proportion of patients who reach therapeutics levels of E-6TGN levels (230-450 pmol/L) at week 6 and week 26. Adverse events defined as any untoward or unfavourable medical occurrence in a human subject Effects on intestinal permeability and microbiota ;Timepoint(s) of evaluation of this end point: 6 weeks, 26 weeks, 52 weeks | — |
Countries
Sweden
Contacts
Public ContactPontus Karling
SOIBD
Outcome results
None listed