NCT04999228 Top Down Versus Step up in Pediatric Ulcerative Colitis
| NCT ID | NCT04999228 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Children's Hospital of Fudan University |
| Condition | Ulcerative Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-11-01 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2021-11-01 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Ying Huang
STUDY DIRECTOR
Children's Hospital of Fudan University
Frequently Asked Questions
Who can join the NCT04999228 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04999228 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04999228 currently recruiting?
Yes, NCT04999228 is actively recruiting participants. Contact the research team at zhengcuifang2@126.com for enrollment information.
Where is the NCT04999228 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT04999228 clinical trial?
NCT04999228 is sponsored by Children's Hospital of Fudan University. The principal investigator is Ying Huang at Children's Hospital of Fudan University. The trial plans to enroll 40 participants.
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