Crohn's disease Digestive System Crohn's disease
Conditions
Interventions
Patients randomised to treatment with 6MP or matching placebo. 6MP will be given at a dose of 1 mg per kg body weight per day, rounded to the nearest 25 mg, for 3 years or until study drug is permanen
Sponsors
University of Edinburgh, Lothian Health Board, University Hospitals Division (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 15/03/2011: 1. At least 16 years of age in Scotland and 18 years of age in England and Wales 2. Established diagnosis of Crohn's disease confirmed at recent resection 3. Ileocolonic or small bowel resection within 3 months before screening 4. No more than 100 cm of fixed small bowel resected in total. Previous ileocolonic resection is acceptable 5. Able to start oral nutrition within the first 2 postoperative weeks 6. Normal or heterozygous TPMT (activity present or reduced consistent with carrier status) 7. Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol 8. Off antibiotics 2 weeks prior to randomisation Previous inclusion criteria: 1. Male or female, at least 16 years of age in Scotland and 18 years of age in England and Wales 2. Established diagnosis of Crohn?s disease 3. Ileocolonic resection within 3 months 4. Able to start oral nutrition and medication within the first 2 postoperative weeks 5. Normal or heterozygous Thio Purine Methyl-Transferase (TPMT) genotype 6. No more than 100 cm of fixed small bowel resected in total. Previous ileocolonic resection is acceptable 7. Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 15/03/2011: 1. Pregnancy at baseline or breastfeeding 2. A known hypersensitivity or intolerance to 6MP 3. Pancreatitis associated with azathioprine 4. Receiving an experimental treatment for Crohn's disease in the 4 weeks prior to study entry 5. Known to require further surgery at study entry i.e. for the removal of an abscess developing from the primary surgery 6. Strictureplasty procedure alone (Please note that strictureplasty and resection procedure together will not be considered an exclusion) 7. Presence of stoma 8. Significant haematological, renal or hepatic dysfunction or clinically important lung disease (i.e. liver function tests [except GGT] >x2 upper limit of normal, haemoglobin ¡Ü10, total white blood cell count 10 days), non-steroidal anti-inflammatory drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-operative recurrence of Crohn?s disease requiring anti-inflammatory rescue therapy and time of recurrence | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The need for a second operation to remove recurrent Crohn?s disease from the anastomotic site 2. Changes in quality of life scores (assessed at 4 weeks [baseline/randomisation], 17 weeks, 1 year, 2 and 3 years using Inflammatory Bowel Disease Questionnaire [IBDQ], Medical Outcome Survey Short Form 36 [SF-36] and EQ-5D) 3. Endoscopic recurrence of Crohn?s disease (assessed at 1 year and 3 years) 4. Relation of faecal calprotectin to time of disease recurrence 5. Relation of drug metabolite levels to time of disease recurrence 6. Exploratory analyses of clinical, genetic and serological markers for predicting disease recurrence | — |
Countries
United Kingdom
Outcome results
None listed