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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05040854
Enrollment
600
Registered
2021-09-10
Start date
2021-07-01
Completion date
2024-07-01
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases

Keywords

Inflammatory Bowel Diseases, HLA, Biological therapy

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.

Interventions

GENETICHLA-DQA1*05 and DRB1

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

Sponsors

Centro Hospitalar Tondela-Viseu
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Response to biological therapy36 monthsTo 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

MeasureTime frameDescription
Prevalence of HLA-DQ1*05 and DRB136 monthsTo determine the prevalence of HLA-DQ1\*05 and DRB1 alleles in IBD population and to compare with a population of healthy blood donor patients.

Countries

Portugal

Contacts

Primary ContactAna Catarina Carvalho, MD
8031@hstviseu.min-saude.pt+351 232420500
Backup ContactPaula Ministro, MD
paulaministro@gmail.com+351 2324200500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026