Monitoring drug levels in children with inflammatory bowel disease
Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease: a Prospective Non-interventional Multicentric Study
Medical University Innsbruck · NCT06954311
This study is testing how well certain medications work for children with inflammatory bowel disease by checking their drug levels during treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 0 Years to 18 Years |
| Sex | All |
| Sponsor | Medical University Innsbruck (other) |
| Drugs / interventions | Infliximab, Adalimumab, Vedolizumab, Ustekinumab |
| Locations | 10 sites (Feldkirch and 9 other locations) |
| Trial ID | NCT06954311 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on pediatric patients diagnosed with inflammatory bowel diseases, specifically ulcerative colitis and IBD-unclassified. It aims to monitor the therapeutic drug levels of biologics such as infliximab and adalimumab in children under 18 years of age who are undergoing treatment. The study will assess the effectiveness and safety of these biologics during both the induction and maintenance phases of therapy. By tracking drug levels, the study seeks to optimize treatment outcomes for young patients suffering from these chronic conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients under 18 years old diagnosed with inflammatory bowel disease and receiving treatment with infliximab, adalimumab, vedolizumab, or ustekinumab.
Not a fit: Patients with primary immunodeficiency will not benefit from this study as they are excluded from participation.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for children with inflammatory bowel disease.
How similar studies have performed: Other studies have shown success in monitoring drug levels in adult populations with similar conditions, suggesting potential for positive outcomes in pediatric cases as well.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Feldkirch and 9 other locations
- Landeskrankenhaus Feldkirch — Feldkirch, Austria (RECRUITING)
- Universitätsklinikum Graz / Medizinische Universität Graz — Graz, Austria (RECRUITING)
- Medical University of Innsbruck — Innsbruck, Austria (RECRUITING)
- Klinikum Klagenfurt — Klagenfurt, Austria (NOT_YET_RECRUITING)
- Kepler Universitätsklinikum Linz — Linz, Austria (RECRUITING)
- Paracelsus Medizinische Privatuniversität — Salzburg, Austria (RECRUITING)
- St. Anna Kinderspital — Vienna, Austria (RECRUITING)
- Universitätsklinik für Kinder- und Jugendheilkunde — Vienna, Austria (NOT_YET_RECRUITING)
- Klinik Donaustadt — Vienna, Austria (NOT_YET_RECRUITING)
- Landeskrankenhaus Villach — Villach, Austria (RECRUITING)
Study contacts
- Study coordinator: Georg-Friedrich Vogel, Assoz. Prof. Dr. PhD
- Email: georg.vogel@i-med.ac.at
- Phone: +43 (0)512/504-82184
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ulcerative Colitis, IBD-unclassified, IBD, Pediatric, Biologicals, Infliximab, Adalimumab, Vedolizumab