Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease
Observational · No treatment assigned · 10 sites · Medical University Innsbruck
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis (UC) and IBD-unclassified (IBD-U). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 0 to 18
- Any sex
Some of the main requirements, copied from the record:
- 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
There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 120 participants are expected to take part.
- Start date: 2025-02-17.
- Main results expected around 2030-02-17 (estimate from the record).
- 10 study sites listed (7 marked recruiting) in Austria.
Main thing being measured
- Pharmacokinetic Evaluation of Plasma Level of Biological Therapy (Plasma Levels will be assessed at Baseline and approximately at Weeks 2, 6, 14, 22, 30, 38, 46, and 54 during routine…)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis (UC); IBD-unclassified (IBD-U) |
| Lead sponsor | Medical University Innsbruck |
| Enrollment | 120 (estimated) |
| Start date | 2025-02-17 |
| Primary completion (est.) | 2030-02-17 |
| First posted | 2025-05-01 |
| Last updated | 2025-05-01 |
| Official title | Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease: a Prospective Non-interventional Multicentric Study |
| ClinicalTrials.gov ID | NCT06954311 |
Interventions
- None listed
Full eligibility criteria (from the record)
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
Locations (10)
| Site | City | Country | Site status |
|---|---|---|---|
| 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 |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.