Clincosm LogoSign in Get a demo

Top Down Versus Step up in Pediatric Ulcerative Colitis

Sponsor
Children's Hospital of Fudan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04999228
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
62
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
First-line Treatment With Infliximab Versus Corticosteroids in Children With Newly Diagnosed Moderate to Severe Ulcerative Colitis
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Infliximab treatment group

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

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.
Other Names:
  • 5-ASA, AZA

    		•
    Active Comparator: Corticosteroid treatment group

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

    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.
    Other Names:
  • 5-ASA, AZA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mucosal healing rate [12 week after intervention]

      The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) ≦1 points is defined as mucosal healing. This will be evaluated by inflammatory bowel disease endoscopist.

    Secondary Outcome Measures

    1. The relapse rates [1 year after intervention]

      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.

    2. Sustained durations of remission [1 year after intervention]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Fudan University Shanghai Shanghai China 201102

    Sponsors and Collaborators

    • Children's Hospital of Fudan University

    Investigators

    • Study Director: Ying Huang, Children's Hospital of Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ying HUANG, Chief of Gastroenterology, Children's Hospital of Fudan University
    ClinicalTrials.gov Identifier:
    NCT04999228
    Other Study ID Numbers:
    • UC1.1
    First Posted:
    Aug 10, 2021
    Last Update Posted:
    Feb 22, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Colitis
    Colitis, Ulcerative
    Ulcer
    Mesalamine
    Infliximab

    Study Results

    No Results Posted as of Feb 22, 2022