Long-term Safety Study of Vedolizumab IV in Children with Ulcerative Colitis or Crohns Disease Following Previous Vedolizumab Treatment in Parent Studies

What this Trial Is About

This research aims to collect long-term safety data on vedolizumab in children with ulcerative colitis UC or Crohns disease CD who have previously participated in related parent studies. It involves up to 240 participants worldwide, including those from treatment or observational cohorts, to better understand the effects of vedolizumab in pediatric patients with these conditions. In the treatment cohort, participants receive intravenous vedolizumab at doses based on their weight, continuing the same blinded dose they received in the parent study at Week 46. Doses are given every 8 weeks, with options ranging from 100 mg to 300 mg depending on participant weight. The study duration in this cohort is up to approximately 5 years or until treatment becomes commercially available or the study closes. The observational cohort includes participants who received at least one dose in the parent study but are not continuing treatment they are followed for safety events for up to about 2 years without receiving vedolizumab. Participants attend assessment visits at several time points after their last dose in the parent study to monitor safety, growth, and development. Researchers track adverse events, inflammatory bowel disease-related events, and changes in quality of life scores using IMPACT-III questionnaires every 24 weeks. The study also includes a final safety visit 18 weeks after the last dose in the treatment cohort. Overall participation lasts up to 5 years for treated children and up to 2 years for those in the observational group.

A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)