Assessment of Safety and Efficacy of Vedolizumab in Pediatric Uclerative Colitis in Comparison With Standard Biological Therapy With Infliximab
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- JAROSLAW KIERKUS
- Enrollment
- 60
- Primary Endpoint
- Safety of biological treatment with vedolizumab and infliximab assessed/defined by the number of drug-related adverse events (AEs).
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
Allocation to therapeutic subgroups will be in a 1:1 ratio.
Eligibility Criteria
- Ages
- 6 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Infliximab arm
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).
Intervention: Infliximab (Drug)
Vedolizumab arm
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).
Intervention: Infliximab (Drug)
Outcomes
Primary Outcomes
Safety of biological treatment with vedolizumab and infliximab assessed/defined by the number of drug-related adverse events (AEs).
Time Frame: screening - Week 20
Information on AEs will be collected on each check-up visit, physical examination, vital signs and lab test will be performed
Secondary Outcomes
No secondary outcomes reported
Investigators
JAROSLAW KIERKUS
Children's Memorial Health Institute
Children's Memorial Health Institute, Poland