Tailored Therapeutic Model According to the Expression of Genes in Inflammatory Bowel Disease Patients

Study Overview
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Brief Summary
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This study is a randomized controlled study conducted at five tertiary university hospitals. Patients who are 20-80 years old, diagnosed as having Inflammatory Bowel Disease(IBD) and who are planned to start thiopurines for the first time for the treatment of IBD are enrolled. Patients are assigned to the genotyping group or to the non-genotyping group. The patients who carry any heterozygotic variant among the three genes receive 50 mg azathioprine (AZA) or 25 mg of 6-mercaptopurine, while those who have any homozygotic variant are recommended to take other alternative drugs. The patients who do not carry any genetic variant or are assigned in non-genotyping group receive the standard dose of thiopurines based on the conventional approach. Patients in the non-genotyping group receive the standard dose of thiopurines based on the conventional approach.

Official Title
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Effectiveness of Tailored Therapeutic Model According to the Expression of Genes Related to Immunomodulator-induced Myelosuppression in Inflammatory Bowel Disease Patients

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Genetic: genotyping for three genes (TPMT, NUDT15 and FTO)
* Other: non-genotyping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20-80 years old Patients who were diagnosed as having IBD based on clinical, endoscopic, radiographic, and histological assessments, Patients who were planned to start thiopurines for the first time for the treatment of IBD. Exclusion Criteria: Patients who had previous use of thiopurine Those who had abnormal laboratory findings prior to screening, including white blood cell (WBC) count < 3,000/μL, platelet (PLT) count < 100/μL, or elevation of aminotransferase more than twice the upper normal limits Those who were diagnosed other infectious diseases at the time of screening or receiving antibiotics within the previous 7 days; Those who were pregnant or lactating.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genotyping group<br>The patients undergo pretreatment of genotyping for three genes (TPMT, NUDT15 and FTO) | Genetic: genotyping for three genes (TPMT, NUDT15 and FTO)<br>* Patients who carry any heterozygotic variants receive 50 mg AZA or 25 mg 6-mercaptopurine (6-MP), while those who have any homozygotic variants are recommended to take other alternative drugs instead of thiopurines<br>|
| Active Comparator: Non-genotyping group<br>Patients receive standard doses of thiopurines based on the conventional regimen without pretreatment genotyping. | Other: non-genotyping<br>* Patients receive standard doses of thiopurines based on the conventional regimen without pretreatment genotyping. Conventional regimen starts with 50 mg of AZA, then the dose is increased by 25 mg in every 1-2 weeks to 2.0-2.5 mg/kg along with regular monitoring of general blood tests including WBC counts.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of myelosuppression |  | 1 year |