Monitoring drug levels in children with inflammatory bowel disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Landeskrankenhaus Feldkirch
  Feldkirch, Austria Recruiting
• Universitätsklinikum Graz / Medizinische Universität Graz
  Graz, Austria Recruiting
• Medical University of Innsbruck
  Innsbruck, Austria Recruiting
• Kepler Universitätsklinikum Linz
  Linz, Austria Recruiting
• Paracelsus Medizinische Privatuniversität
  Salzburg, Austria Recruiting
• St. Anna Kinderspital
  Vienna, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.