Top Down Versus Step up in Pediatric Ulcerative Colitis

Last updated: February 26, 2024
Sponsor: Children's Hospital of Fudan University
Overall Status: Active - Recruiting

Phase

4

Condition

Ulcerative Colitis

Inflammatory Bowel Disease

Ulcers

Treatment

Infliximab

Corticosteroids

Clinical Study ID

NCT04999228
UC1.1
  • Ages 6-18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. newly diagnosed UC;
  2. moderate to severe disease activity
  3. Age: 6 to 18 years old

Exclusion

Exclusion Criteria:

  1. with mild disease activity
  2. Have been treated with Corticosteroid or biological agents for UC

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Infliximab
Phase: 4
Study Start date:
November 01, 2021
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Children's Hospital of Fudan University

    Shanghai, Shanghai 201102
    China

    Active - Recruiting

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