Inflammatory Bowel DiseasesNCT05040854
Can we Rely on HLA to Predict Resistance to Biological Therapy in IBD Patients
An observational study of Inflammatory Bowel Diseases, run by Centro Hospitalar Tondela-Viseu at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- HLA-DQA1*05 and DRB1
- How many people
- 600 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jul 2021to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients with the diagnosis of IBD (according to ECCO diagnosis criteria);
- Adult patients (over 18 years);
- Full capability of signing informed consent.
Who cannot join
- Patients who refuse to participate in the study;
- Patients submitted to prior biological therapy (only for the IBD-naive group)
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Centro Hospitalar Tondela Viseu
Viseu, 3504-509
Paula Ministro, MD, +351 232420500, paulaministro@gmail.com
About this study
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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- HLA-DQA1*05 and DRB1
- Keywords
- Inflammatory Bowel Diseases, HLA, Biological therapy
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLA-DQA1*05 and DRB1Genetic
All patients will be asked to give blood samples to search for HLA-DQA1*05 and DRB1
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Blood donors Receives: Genetic: 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. Receives: Genetic: 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, Receives: Genetic: HLA-DQA1*05 and DRB1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 36 months
Secondary outcomes (1)
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start1 Jul 2021
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Tondela-Viseu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Carvalho, Centro Hospitalar Tondela-Viseu
- Investigators
- Paula Ministro, MD, Study director, Centro Hospitalar Tondela-Viseu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040854
- Sponsor's protocol ID
- CHTV07/2021.1
- Status last verified
- Sep 2021
- First submitted
- 2 Sep 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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. Ther Adv Gastroenterol. 2025 Jul 11;18:17562848251353293. doi: 10.1177/17562848251353293. eCollection 2025.
PubMed 40655132
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can we Rely on HLA to Predict Resistance to Biological Therapy in IBD Patients
- ClinicalTrials.gov ID
- NCT05040854
- Acronym / sponsor ID
- CHTV07/2021.1
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Inflammatory Bowel Diseases, HLA, Biological therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Centro Hospitalar Tondela-ViseuUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | – | Genetic: HLA-DQA1*05 and DRB1Blood donors |
| IBD patients - under biological therapy | – | Genetic: HLA-DQA1*05 and DRB1Patients with IBD followed up in consultation on biological therapy with anti-TNF, anti-integrin α₄β₇ or anti-interleukin 12-23. |
| IBD patients - naive | – | Genetic: HLA-DQA1*05 and DRB1Patients newly diagnosed with IBD and need for biological therapy with anti-TNF, anti-integrin α₄β₇ or anti-interleukin 12-23, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients with the diagnosis of IBD (according to ECCO diagnosis criteria);
- Adult patients (over 18 years);
- Full capability of signing informed consent.
Key exclusion criteria (2 listed)
- Patients who refuse to participate in the study;
- Patients submitted to prior biological therapy (only for the IBD-naive group)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLA-DQA1*05 and DRB1All patients will be asked to give blood samples to search for HLA-DQA1*05 and DRB1 | Genetic | Healthy Subjects, IBD patients - naive, IBD patients - under biological therapy |
Primary outcome
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).
1 secondary outcome
Prevalence of HLA-DQ1*05 and DRB1
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Derived from this study: PubMed 40655132Domingues 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. Ther Adv Gastroenterol. 2025 Jul 11;18:17562848251353293. doi: 10.1177/17562848251353293. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Ministro, MD study director
Centro Hospitalar Tondela-Viseu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Centro Hospitalar Tondela-Viseu at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Catarina Carvalho, MD (+351 232420500, 8031@hstviseu.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to biological therapy (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05040854, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.