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

September 9, 2021 updated by: Ana Carvalho, Centro Hospitalar Tondela-Viseu
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Portugal
      • Viseu, Portugal, 3504-509
        • Recruiting
        • Centro Hospitalar Tondela Viseu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to biological therapy
Time Frame: 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).
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of HLA-DQ1*05 and DRB1
Time Frame: 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.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Hospitalar Tondela-Viseu

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

September 2, 2021

First Submitted That Met QC Criteria

September 9, 2021

First Posted (Actual)

September 10, 2021

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 9, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHTV07/2021.1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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