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
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

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