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NCT05040854 Clinical Trial

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

Inflammatory Bowel Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05040854
Other study ID # CHTV07/2021.1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2021
Est. completion date July 1, 2024

Study information
Verified date September 2021
Source Centro Hospitalar Tondela-Viseu
Contact Ana Catarina Carvalho, MD
Phone +351 232420500
Email 8031@hstviseu.min-saude.pt
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date July 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Genetic:
• HLA-DQA1*05 and DRB1
All patients will be asked to give blood samples to search for HLA-DQA1*05 and DRB1

Locations
Country Name City State
Portugal Centro Hospitalar Tondela Viseu Viseu

Sponsors (1)
Lead Sponsor Collaborator
Centro Hospitalar Tondela-Viseu

Country where clinical trial is conducted

Portugal, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 a4ß7 (Vedolizumab) or anti-interleukin 12-23 (Ustekinumab). 36 months
Secondary Prevalence of HLA-DQ1*05 and DRB1 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. 36 months
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