Actively Recruiting
Top Down Versus Step up in Pediatric Ulcerative Colitis
Led by Children's Hospital of Fudan University · Updated on 2024-02-28
40
Participants Needed
1
Research Sites
269 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Top Down Versus Step up in Pediatric Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed ulcerative colitis
- Moderate to severe disease activity
- Age between 6 and 18 years old
You will not qualify if you...
- Mild disease activity
- Previous treatment with corticosteroids or biological agents for ulcerative colitis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102
Actively Recruiting
Research Team
C
Cui fang Zheng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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