Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease

Launched by MEDICAL UNIVERSITY INNSBRUCK · Apr 24, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating how certain medications, known as biologics, work in children with Inflammatory Bowel Disease (IBD), specifically those diagnosed with ulcerative colitis or IBD-unclassified. The goal is to better understand how these drugs, like infliximab and adalimumab, are absorbed and how well they help manage the disease in young patients. The study will include at least 40 children under 18 years old who are receiving these treatments, along with 20 children using other biologics like vedolizumab or ustekinumab.

Participants in the trial will not need to attend extra visits—data will be collected during their regular check-ups at their clinic. To be eligible, children must be under 18 years old and have a diagnosis of IBD, and they must be currently receiving one of the specified biologic treatments. However, children with certain immune system issues will not be included. This study is important because it aims to improve how doctors can monitor and adjust these medications for better treatment outcomes in pediatric patients.

Gender

ALL

Eligibility 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