Vedolizumab in Pediatric Ulcerative Colitis- Comparison With Infliximab
Status:
NOT_YET_RECRUITING
Trial end date:
2028-11-30
Target enrollment:
Participant gender:
Summary
This is a multicenter, double-blind, randomized study to compare the safety, effectiveness and immunogenicity (antibodies against drug) of two biological drugs administered intravenously - vedolizumab (a drug not registered in pediatric patients) and infliximab (used as standard therapy), in pediatric patients with UC aged 6-18 years.
Before enrollment to the study, informed consent must be obtained from the participant's legal guardian and, additionally, from the participant aged \>16 years before any procedures are performed.