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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Patients meeting the inclusion criteria and not having any of the exclusion criteria will be randomized 1:1 to one of two study arms - intravenous administration of blinded active drug, infliximab or vedolizumab at weeks 0, 2, 6 and 14. Infliximab will be administered at a dose 5mg/kg body weight, and vedolizumab at a dose of 300 mg (body mass \> 40 kg) and 10 mg/kg (body mass \< 40kg).
Safety of biological treatment with vedolizumab and infliximab assessed/defined by the number of drug-related adverse events (AEs).
Information on AEs will be collected on each check-up visit, physical examination, vital signs and lab test will be performed
Time frame: screening - Week 20
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