Clinical Trial

Top Down Versus Step up in Pediatric Ulcerative Colitis

Recruiting Phase 4
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Record status
This record was last updated February 28, 2024 (before its estimated June 1, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2021-08-05; most recent amendment 2024-02-26.
Status change: Not Yet Recruiting → Recruiting 2022-02-05
Trial Details
NCT Number NCT04999228
Lead Sponsor Children's Hospital of Fudan University
Conditions Ulcerative Colitis, Infliximab, Children
Enrollment 40 participants
Start Date 2021-11-01
Primary Completion 2025-06-01 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-02-28