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

Yonsei University

Status: Completed

Conditions: Inflammatory Bowel Diseases

Treatments: Genetic: genotyping for three genes (TPMT, NUDT15 and FTO); Other: non-genotyping

Study type: Interventional

Funder types: Other

Identifiers

NCT03719118

4-2015-0812

Details and patient eligibility

About

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.

Enrollment: 215 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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215 participants in 2 patient groups

Genotyping group

Experimental group

Description:

The patients undergo pretreatment of genotyping for three genes (TPMT, NUDT15 and FTO)

Treatment:

Genetic: genotyping for three genes (TPMT, NUDT15 and FTO)

Non-genotyping group

Active Comparator group

Description:

Patients receive standard doses of thiopurines based on the conventional regimen without pretreatment genotyping.

Treatment:

Other: non-genotyping