First-line Treatment With Infliximab Versus Corticosteroids in Children With Newly Diagnosed Moderate to Severe Ulcerative Colitis

Who is this study for? Children with newly diagnosed moderate to severe ulcerative colitis
What treatments are being studied? Infliximab
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 18
Healthy Volunteers: f
View:

• newly diagnosed UC;

• moderate to severe disease activity

• Age: 6 to 18 years old

Locations
Other Locations
China
Children's Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Cui fang Zheng
zhengcuifang2@126.com
8615221881022
Time Frame
Start Date: 2021-11-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 40
Treatments
Experimental: Infliximab treatment group
For newly diagnosed moderate to severe Pediatric ulcerative colitis, infliximab will be used as first-line treatment
Active_comparator: Corticosteroid treatment group
For newly diagnosed moderate to severe Pediatric ulcerative colitis, corticosteroids will be used as first-line treatment
Sponsors
Leads: Children's Hospital of Fudan University

This content was sourced from clinicaltrials.gov

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