Top Down Versus Step up in Pediatric Ulcerative Colitis
First-line Treatment With Infliximab Versus Corticosteroids in Children With Newly Diagnosed Moderate to Severe Ulcerative Colitis
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2021
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2021
CompletedFirst Posted
Study publicly available on registry
August 10, 2021
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedFebruary 28, 2024
February 1, 2024
3.6 years
August 5, 2021
February 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Mucosal healing rate
The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) ≦1 points is defined as mucosal healing. This will be evaluated by inflammatory bowel disease endoscopist.
12 week after intervention
Secondary Outcomes (2)
The relapse rates
1 year after intervention
Sustained durations of remission
1 year after intervention
Study Arms (2)
Infliximab treatment group
EXPERIMENTALFor newly diagnosed moderate to severe Pediatric ulcerative colitis, infliximab will be used as first-line treatment
Corticosteroid treatment group
ACTIVE COMPARATORFor newly diagnosed moderate to severe Pediatric ulcerative colitis, corticosteroids will be used as first-line treatment
Interventions
Infliximab will be administered intravenously at a dose of 5 mg/kg for 0, 2, and 6 weeks, then every 8 weeks for 1 year.
Corticosteroid will be given at a dose of 1-2mg/kg/day (maximum 60 mg/kg/day),oral or intravenously for 12 to 14 weeks.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ying Huang
Children's Hospital of Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Gastroenterology
Study Record Dates
First Submitted
August 5, 2021
First Posted
August 10, 2021
Study Start
November 1, 2021
Primary Completion
June 1, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
February 28, 2024
Record last verified: 2024-02