Top Down Versus Step up in Pediatric Ulcerative Colitis
Status:
Not yet recruiting
Trial end date:
2026-12-31
Target enrollment:
Participant gender:
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.