Top Down Versus Step up in Pediatric Ulcerative Colitis

Fudan University

Status and phase: Enrolling; Phase 4

Conditions: Children; Ulcerative Colitis; Infliximab

Treatments: Drug: Corticosteroids; Drug: Infliximab

Study type: Interventional

Funder types: Other

Identifiers

NCT04999228

UC1.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Infliximab treatment group

Experimental group

Description:

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

Treatment:

Drug: Infliximab

Corticosteroid treatment group

Active Comparator group

Description:

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

Treatment:

Drug: Corticosteroids