Can we Rely on HLA to Predict Resistance to Biological Therapy in IBD Patients
1 other identifier
observational
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2021
CompletedFirst Submitted
Initial submission to the registry
September 2, 2021
CompletedFirst Posted
Study publicly available on registry
September 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedSeptember 16, 2021
September 1, 2021
2.8 years
September 2, 2021
September 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response to biological therapy
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).
36 months
Secondary Outcomes (1)
Prevalence of HLA-DQ1*05 and DRB1
36 months
Study Arms (3)
Healthy Subjects
Blood donors
IBD patients - under biological therapy
Patients with IBD followed up in consultation on biological therapy with anti-TNF, anti-integrin α₄β₇ or anti-interleukin 12-23.
IBD patients - naive
Patients newly diagnosed with IBD and need for biological therapy with anti-TNF, anti-integrin α₄β₇ or anti-interleukin 12-23,
Interventions
All patients will be asked to give blood samples to search for HLA-DQA1\*05 and DRB1
Eligibility Criteria
Patients with Inflammatory Bowel Disease under biological therapy with anti-TNF, anti-integrin α₄β₇ or and anti-interleukin 12-23, followed in a gastroenterology outpatient consultation at the Centro Hospitalar Tondela-Viseu.
You may qualify if:
- Patients with the diagnosis of IBD (according to ECCO diagnosis criteria);
- Adult patients (over 18 years);
- Full capability of signing informed consent.
You may not qualify if:
- Patients who refuse to participate in the study;
- Patients submitted to prior biological therapy (only for the IBD-naive group)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro Hospitalar Tondela Viseu
Viseu, 3504-509, Portugal
Related Publications (1)
Domingues A, Carvalho A, Martinho A, Soares C, Martins D, Sousa P, Araujo R, Cancela E, Silva A, Ministro P. Predicting resistance to biological therapy using human leukocyte antigen genes in patients with inflammatory bowel disease. Therap Adv Gastroenterol. 2025 Jul 11;18:17562848251353293. doi: 10.1177/17562848251353293. eCollection 2025.
PMID: 40655132DERIVED
Biospecimen
Blood samples regarding inflammatory biomarkers and MHC class II
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paula Ministro, MD
Centro Hospitalar Tondela-Viseu
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 2, 2021
First Posted
September 10, 2021
Study Start
July 1, 2021
Primary Completion
April 1, 2024
Study Completion
July 1, 2024
Last Updated
September 16, 2021
Record last verified: 2021-09