Top Down Versus Step up in Pediatric Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04999228
• Other study ID #: UC1.1
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Children's Hospital of Fudan University
• Contact: Cui fang Zheng
• Phone: 8615221881022
• Email: zhengcuifang2[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Children
• Colitis
• Colitis, Ulcerative
• Infliximab
• Ulcer
• Ulcerative Colitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The relapse rates	Relapse is defined as an increased in pediatric Ulcerative Colitis activity index (PUCAI) score by 10 points or more after clinical remission or when new Ulcerative Colitis treatment needed to be started due to worsening of symptoms. This will be evaluated by gastroenterologist.	1 year after intervention
Secondary	Sustained durations of remission	Sustained pediatric Ulcerative Colitis activity index (PUCAI) score <10 points during follow-up(week 10 to week 54 after intervention). This will be evaluated by gastroenterologist.	1 year after intervention