Crohn's Disease and Ulcerative Colitis Inflammatory Bowel Disease
Conditions
Interventions
Following randomization, 500 patients will be genotyped prior to treatment with
the clinician receiving advice on thiopurine dosing
an equal number will
receive standard treatment.
Sponsors
Zorgonderzoek Nederland (ZON)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: · Age 18 or older · Diagnosis of a form of IBD · Patient is started on azathioprine treatment · Patient giving informed consent
Exclusion criteria
Exclusion criteria: · Previous treatment with azathioprine · Co-prescription of allopurinol (this treatment blocks xanthine oxidase, an enzyme important for azathioprine metabolism) · Baseline leukocyte count less then 3x10^9 per litre · Reduced baseline liver function · Reduced renal function at baseline · Use of TPMT phenotype test to guide prescription · Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome measures are occurrence of ADRs, clinical outcome after 5 months of treatment, quality of life and treatment costs. | — |
Secondary
| Measure | Time frame |
|---|---|
| In a second phase, after inclusion of all patients and completion of the cost-effectiveness study the DNA and phenotype data will be used for exploratory analyses of other genes influencing treatment response. | — |
Countries
Netherlands
Outcome results
None listed