Top Down Versus Step up in Pediatric Ulcerative Colitis

NCT ID: NCT04999228

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2026-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Infliximab treatment group

For newly diagnosed moderate to severe Pediatric ulcerative colitis, infliximab will be used as first-line treatment

Group Type: EXPERIMENTAL

Infliximab

Intervention Type: DRUG

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 treatment group

For newly diagnosed moderate to severe Pediatric ulcerative colitis, corticosteroids will be used as first-line treatment

Group Type: ACTIVE_COMPARATOR

Corticosteroids

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

5-ASA, AZA; 5-ASA, AZA

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Ying HUANG

Chief of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ying Huang

Role: STUDY_DIRECTOR

Children's Hospital of Fudan University

Locations

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Cui fang Zheng

Role: CONTACT

zhengcuifang2@126.com

8615221881022

Facility Contacts

Cui Zheng

Role: primary

zhengcuifang2@126.com

Other Identifiers

UC1.1

Identifier Type: -

Identifier Source: org_study_id