Monitoring Biological Treatments in Children With Inflammatory Bowel Disease A Study of Medications Infliximab, Adalimumab, Vedolizumab, and Ustekinumab

What this Trial Is About

Inflammatory Bowel Diseases IBD, including Crohns disease, ulcerative colitis, and indeterminate colitis, are often diagnosed in children and young adults, with a rising number of cases in this age group. Various immunomodulatory treatments, especially biologic antibodies targeting specific immune pathways, are used to manage IBD. This research focuses on monitoring these biologic therapies in pediatric patients to better understand their behavior and how they relate to treatment responses. This observational study involves children under 18 with IBD who are treated with one of four biologic therapies infliximab, adalimumab, vedolizumab, or ustekinumab. Patients are grouped based on the biologic they receive during induction or maintenance treatment phases. The study collects data from routine clinical visits over five years without any extra interventions or visits required. Participants will be monitored at baseline and approximately at weeks 2, 6, 14, 22, 30, 38, 46, and 54 during their regular follow-up appointments. Researchers will measure drug levels in the blood, clinical disease activity scores, laboratory markers like calprotectin, and the development of antibodies against the biologics. The study aims to understand how these factors change over time and relate to treatment outcomes, using information gathered solely from standard care visits.

Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease