Vedolizumab in Pediatric Ulcerative Colitis- Comparison With Infliximab

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

October 1, 2024

Primary Completion Date

April 30, 2028

Study Completion Date

November 30, 2028

Conditions
Ulcerative Colitis
Interventions
DRUG

Infliximab

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).

All Listed Sponsors
lead

JAROSLAW KIERKUS

OTHER