Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease
NCT ID: NCT06954311
Last Updated: 2025-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2025-02-17
2030-02-17
Brief Summary
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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 frequently used off-label in cases of treatment failure with approved therapies, as efficacy has been demonstrated in adult IBD patients, and since 2015, increasing pediatric literature has emerged on their use.
To facilitate appropriate dose adjustment in pediatric clinical practice, biologic therapies can be monitored through measurement of drug trough levels. Current pediatric guidelines already recommend incorporating therapeutic drug monitoring (TDM) of infliximab and adalimumab in the management of CD and UC. Studies on TDM for vedolizumab and ustekinumab have so far been conducted almost exclusively in adult IBD patients, where improved treatment responses have also been demonstrated.
The presented research is a prospective, non-interventional observational study involving pediatric IBD patients at multiple Austrian pediatric gastroenterology centers. The study duration is five years. The aim is to include at least 40 patients receiving induction and maintenance therapy with infliximab or adalimumab, and 20 patients treated with vedolizumab or ustekinumab during both treatment phases. The primary objective is to gain a better understanding of the pharmacokinetic dynamics of these biologics and the associated treatment response in pediatric settings. Data will be collected exclusively from routine clinical assessments. No additional study-related visits or interventions are planned.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Infliximab Group
those who receive Infliximab
No interventions assigned to this group
Adalimumab Group
those who receive Adalimumab
No interventions assigned to this group
Vedolizumab Group
those who receive Vedolizumab
No interventions assigned to this group
Ustekinumab Group
those who receive Ustekinumab
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Treatment with Infliximab, Adalimumab, Vedolizumab, or Ustekinumab during induction or maintenance phase
Exclusion Criteria
0 Years
18 Years
ALL
No
Sponsors
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Medical University Innsbruck
OTHER
Responsible Party
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Locations
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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
Klinik Donaustadt
Vienna, , Austria
Landeskrankenhaus Villach
Villach, , Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TDMpIBD (1126/2024)
Identifier Type: -
Identifier Source: org_study_id
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