An observational study in Inflammatory Bowel Diseases, sponsored by Centro Hospitalar Tondela-Viseu. Status unknown at 1 site in Portugal. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-16.
Sponsored by Centro Hospitalar Tondela-Viseu · Observational
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.
963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.
This study's planned enrollment of 600 is above the median of 140 across 377 observational studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →Centro Hospitalar Tondela-Viseu is the lead sponsor of 5 studies on the registry; none are open to participants now.
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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.
Exclusion Criteria:
Blood donors
Genetic: HLA-DQA1*05 and DRB1
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
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
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).
Time frame: 36 months
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.
Time frame: 36 months
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Centro Hospitalar Tondela-Viseu