Top Down Versus Step up in Pediatric Ulcerative Colitis
First-line Treatment With Infliximab Versus Corticosteroids in Children With Newly Diagnosed Moderate to Severe Ulcerative Colitis
Children's Hospital of Fudan University
40 participants
Nov 1, 2021
INTERVENTIONAL
Conditions
Summary
Pediatric Ulcerative Colitis (UC) patients with moderate to severe disease activity at high risk of colectomy. Early use of biologic agents will likely be more effective. But there were no studies identified that compared a strategy of upfront biologic-based therapy versus gradual step-up therapy. In our study, newly diagnosed moderate to severe pediatric UC patients (6-18 years old) will be randomly divided into infliximab (IFX) treatment group (Top down group, TD) and corticosteroids (CS) treatment group (Step-up group, SU). Mucosal healing rate at week 12 will be compared between the two groups. The relapse rates and sustained durations of remission within one year will also be evaluated.
Eligibility
Inclusion Criteria3
- newly diagnosed UC;
- moderate to severe disease activity
- Age: 6 to 18 years old
Exclusion Criteria2
- with mild disease activity
- Have been treated with Corticosteroid or biological agents for UC
Interventions
Infliximab will be administered intravenously at a dose of 5 mg/kg for 0, 2, and 6 weeks, then every 8 weeks for 1 year.
Corticosteroid will be given at a dose of 1-2mg/kg/day (maximum 60 mg/kg/day),oral or intravenously for 12 to 14 weeks.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04999228