Vedolizumab in Pediatric Ulcerative Colitis- Comparison With Infliximab

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.

Timeline

Start

2024-10-01

Primary completion

2028-04-30

Completion

2028-11-30

Drugs

Indications