Pharmacogenetic testing in the clinical setting: is screening for TPMT genotype a cost-effective treatment strategy? The first prospective randomized controlled trial within the Dutch health care system.
- Conditions
- Crohn's Disease and Ulcerative ColitisInflammatory Bowel Disease10017969
- Registration Number
- NL-OMON30092
- Lead Sponsor
- Zorgonderzoek Nederland (ZON)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 1000
Inclusion Criteria
· Age 18 or older
· Diagnosis of a form of IBD
· Patient is started on azathioprine treatment
· Patient giving informed consent
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Outcome measures are occurrence of ADRs, clinical outcome after 5 months of<br /><br>treatment, quality of life and treatment costs.</p><br>
- Secondary Outcome Measures
Name Time Method <p>In a second phase, after inclusion of all patients and completion of the<br /><br>cost-effectiveness study the DNA and phenotype data will be used for<br /><br>exploratory analyses of other genes influencing treatment response.</p><br>