Top Down Versus Step up in Pediatric Ulcerative Colitis

Recruiting now · Phase 4

Conditions studied: Ulcerative Colitis, Infliximab, Children

In brief

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.

Key facts

Study ID

NCT04999228

Run by

Children's Hospital of Fudan University

People needed

40

Starts

2021-11-01

Expected to finish

2026-12-31

Last updated by the study team

2024-02-28

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• newly diagnosed UC;
• moderate to severe disease activity
• Age: 6 to 18 years old

You may not qualify if…

• with mild disease activity
• Have been treated with Corticosteroid or biological agents for UC

Where it is running

• Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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