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

Sponsor
Centro Hospitalar Tondela-Viseu (Other)
Overall Status
Recruiting
CT.gov ID
NCT05040854
Collaborator
(none)
600
Enrollment
1
Location
36
Anticipated Duration (Months)
16.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: HLA-DQA1*05 and DRB1

Study Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Can we Rely on HLA to Predict Resistance to Biological Therapy in IBD Patients
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Healthy Subjects

Blood donors

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

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

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centro Hospitalar Tondela Viseu Viseu Portugal 3504-509

Sponsors and Collaborators

  • Centro Hospitalar Tondela-Viseu

Investigators

  • Study Director: Paula Ministro, MD, Centro Hospitalar Tondela-Viseu

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ana Carvalho, Principal Investigator, Centro Hospitalar Tondela-Viseu
ClinicalTrials.gov Identifier:
NCT05040854
Other Study ID Numbers:
  • CHTV07/2021.1
First Posted:
Sep 10, 2021
Last Update Posted:
Sep 16, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ana Carvalho, Principal Investigator, Centro Hospitalar Tondela-Viseu
Inflammatory Bowel Diseases
HLA
Biological therapy
Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases

Study Results

No Results Posted as of Sep 16, 2021