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Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease

Recruitingn/aAges 0 Years - 18 YearsAllMedical University Innsbruck
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In plain words

What the trial is, and whether it could suit you

Inflammatory Bowel Diseases (IBD), which include Crohn's disease (CD), ulcerative colitis (UC), and the unclassified form referred to as indeterminate colitis, are most commonly diagnosed during adolescence and early adulthood. In recent decades, an increasing incidence of IBD has been observed in this age group. A wide range of immunomodulatory agents, from corticosteroids to monoclonal antibodies, are now available for the treatment of IBD. These antibodies, known as biologics, target, for example, tumor necrosis factor-alpha (TNF-α; e.g., infliximab and adalimumab), integrin α4β7 (vedolizumab), or interleukin-12/23 (ustekinumab). While infliximab and adalimumab are approved for pediatric use in CD and UC, vedolizumab is only approved for moderate-to-severe UC from the age of 16, and ustekinumab is not approved for pediatric use at all. Nevertheless, vedolizumab and ustekinumab are fr

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Pediatric patients with an Inflammatory Bowel Disease (Crohn's disease, ulcerative colitis, and IBD-unclassified) being under 18 years of age * Treatment with Infliximab, Adalimumab, Vedolizumab, or Ustekinumab during induction or maintenance phase Exclusion Criteria: \-- Patients with primary (congenital) immunodeficiency
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What it tests

  • Not listed
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Where

10 sites
Landeskrankenhaus Feldkirch
Feldkirch, Austria
Universitätsklinikum Graz / Medizinische Universität Graz
Graz, Austria
Medical University of Innsbruck
Innsbruck, Austria
Klinikum Klagenfurt
Klagenfurt, Austria
Kepler Universitätsklinikum Linz
Linz, Austria
Paracelsus Medizinische Privatuniversität
Salzburg, Austria
St. Anna Kinderspital
Vienna, Austria
Universitätsklinik für Kinder- und Jugendheilkunde
Vienna, Austria

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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