NCT04999228

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Pediatric ulcerative colitis (UC) is typically more extensive and has a more active disease course than adult UC. Pediatric UC patients with moderate to severe disease activity at high risk of colectomy. Rapid disease control may improve the prognosis of the disease and reduce the rate of surgery. 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). A decrease of pediatric ulcerative colitis activity index (PUCAI) at least 20 points were defined as Clinical response. Clinical response will be evaluated at week 2 in SU group and week 6 in TD group. For no-responder, treatment plan will be changed. Clinical remission rate at week 10 and 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

• Ulcerative Colitis
• Infliximab
• Children

Interventions

Type	Name	Description
DRUG	Infliximab	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.
DRUG	Corticosteroids	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.

Timeline

• Start date: 2021-11-01
• Primary completion: 2025-06-01
• Completion: 2026-12-31
• First posted: 2021-08-10
• Last updated: 2024-02-28

Locations

1 site across 1 country: China