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

• Conditions: Inflammatory Bowel Diseases
• Interventions: Genetic: HLA-DQA1*05 and DRB1

• Registration Number: NCT05040854
• Lead Sponsor: Centro Hospitalar Tondela-Viseu

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Status Verified: 2021-09
• Study First Submitted: 2021-09-02
• Study First Submitted QC: 2021-09-09
• Last Update Submitted: 2021-09-09
• Study First Posted: 2021-09-10
• Last Update Posted: 2021-09-16
• Primary Completion: 2024-04-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IBD patients - naive	HLA-DQA1*05 and DRB1	Patients newly diagnosed with IBD and need for biological therapy with anti-TNF, anti-integrin α₄β₇ or anti-interleukin 12-23,
IBD patients - under biological therapy	HLA-DQA1*05 and DRB1	Patients with IBD followed up in consultation on biological therapy with anti-TNF, anti-integrin α₄β₇ or anti-interleukin 12-23.
Healthy Subjects	HLA-DQA1*05 and DRB1	Blood donors

Primary Outcome Measures

Name	Time	Method
Response to biological therapy	36 months	To assess whether the presence of the HLA-DQA1\*05 and HLA DRB1 alleles in patients with inflammatory bowel disease is associated with primary failure or loss of response to biological therapy with anti-TNF (Infliximab and Adalimumab), anti-integrin α₄β₇ (Vedolizumab) or anti-interleukin 12-23 (Ustekinumab).

Secondary Outcome Measures

Name	Time	Method
Prevalence of HLA-DQ1*05 and DRB1	36 months	To determine the prevalence of HLA-DQ1\*05 and DRB1 alleles in IBD population and to compare with a population of healthy blood donor patients.

Trial Locations

Locations (1)

Centro Hospitalar Tondela Viseu; 🇵🇹 Viseu, Portugal