Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Subjects | Blood donors |
| |
| 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. |
| |
| IBD patients - naive | Patients newly diagnosed with IBD and need for biological therapy with anti-TNF, anti-integrin α₄β₇ or anti-interleukin 12-23, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLA-DQA1*05 and DRB1 | Genetic | All patients will be asked to give blood samples to search for HLA-DQA1*05 and DRB1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana Catarina Carvalho, MD | Contact | +351 232420500 | 8031@hstviseu.min-saude.pt | |
| Paula Ministro, MD | Contact | +351 2324200500 | paulaministro@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Paula Ministro, MD | Centro Hospitalar Tondela-Viseu | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar Tondela Viseu | Recruiting | Viseu | 3504-509 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40655132 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood samples regarding inflammatory biomarkers and MHC class II