Top Down Versus Step up in Pediatric Ulcerative Colitis
Recruiting
Phase 4
Interventional Study
Ulcerative Colitis
Infliximab
Children
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 – 18
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 40 (estimated)
- Sponsor
- Children's Hospital of Fudan University · Other
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About This Trial
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 rando…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. newly diagnosed UC;
2. moderate to severe disease activity
3. Age: 6 to 18 years old
Exclusion Criteria:
1. with mild disease activity
2. Have been treated with Corticosteroid or biological agents for UC
Contacts