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

N/ACompletedNCT03719118

Yonsei University215 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

215

Conditions

Inflammatory Bowel Diseases

Interventions

non-genotypingOTHER

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (5)

Severance Hospital

Seoul, South Korea

Ewha Medical Research Institute

Seoul, South Korea

Gangnam Severance Hospital

Seoul, South Korea

Korea University Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

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

Overview

Conditions

Interventions

Eligibility

Locations (5)

Outcomes

Primary Outcomes