Can we Rely on HLA to Predict Resistance to Biological Therapy in IBD Patients

Centro Hospitalar Tondela-Viseu

Status: Enrolling

Conditions: Inflammatory Bowel Diseases

Treatments: Genetic: HLA-DQA1*05 and DRB1

Study type: Observational

Funder types: Other

Identifiers

NCT05040854

CHTV07/2021.1

Details and patient eligibility

About

The investigators propose an observational study including patients with inflammatory bowel disease under biological therapy with anti-TNF, anti-integrin α₄β₇ or anti-interleukin 12-23 (Ustekinumab), followed by an external Gastroenterology consultation at Centro Hospitalar Tondela-Viseu.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with the diagnosis of IBD (according to ECCO diagnosis criteria);
• Adult patients (over 18 years);
• Full capability of signing informed consent.

Exclusion criteria

• Patients who refuse to participate in the study;
• Patients submitted to prior biological therapy (only for the IBD-naive group)

Trial design

600 participants in 3 patient groups

Healthy Subjects

Description:

Blood donors

Treatment:

Genetic: HLA-DQA1*05 and DRB1

IBD patients - under biological therapy

Description:

Patients with IBD followed up in consultation on biological therapy with anti-TNF, anti-integrin α₄β₇ or anti-interleukin 12-23.

Treatment:

Genetic: HLA-DQA1*05 and DRB1

IBD patients - naive

Description:

Patients newly diagnosed with IBD and need for biological therapy with anti-TNF, anti-integrin α₄β₇ or anti-interleukin 12-23,

Treatment:

Genetic: HLA-DQA1*05 and DRB1