Top Down Versus Step up in Pediatric Ulcerative Colitis
Recruiting · NCT04999228 · Interventional (participants receive a specific treatment) · Lead sponsor: Children's Hospital of Fudan University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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.
Who can take part
Inclusion criteria
- newly diagnosed UC;
- moderate to severe disease activity
- Age: 6 to 18 years old
Exclusion criteria
- with mild disease activity
- Have been treated with Corticosteroid or biological agents for UC
Where it is running
1 location listed.
- Children's Hospital of Fudan University - Shanghai, Shanghai Municipality, China