Infliximab Versus Steroids as First Treatment for Children With Ulcerative Colitis
Compares infliximab with steroids as first treatment for children with new, moderate to severe colitis.
Plain-language title generated from the registry record
Registry title: Top Down Versus Step up in Pediatric Ulcerative Colitis
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 18 years old?
Source: NCT04999228, who can take part
Where in China
- Children's Hospital Of Fudan UniversityShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Children's Hospital of Fudan University
- Trial code
- NCT04999228
- Record updated
- 28 February 2024
- Original description
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.Read full original descriptionShow less
First-line Treatment With Infliximab Versus Corticosteroids in Children With Newly Diagnosed Moderate to Severe Ulcerative Colitis
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.
Inclusion: newly diagnosed UC; moderate to severe disease activity; Age: 6 to 18 years old.
Exclusion: Have been treated with Corticosteroid or biological agents for UC; with mild disease activity.