Top Down Versus Step up in Pediatric Ulcerative Colitis
Phase 4 · Testing Infliximab and Corticosteroids · 1 site · Children's Hospital of Fudan University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Infliximab (a drug) and Corticosteroids (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis, Infliximab and Children.
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 6 to 18
- Any sex
Some of the main requirements, copied from the record:
- newly diagnosed UC;
- moderate to severe disease activity
- Age: 6 to 18 years old
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2021-11-01.
- Main results expected around 2025-06-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Mucosal healing rate (12 week after intervention)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis; Infliximab; Children |
| Lead sponsor | Children's Hospital of Fudan University |
| Enrollment | 40 (estimated) |
| Start date | 2021-11-01 |
| Primary completion (est.) | 2025-06-01 |
| First posted | 2021-08-10 |
| Last updated | 2024-02-28 |
| Official title | First-line Treatment With Infliximab Versus Corticosteroids in Children With Newly Diagnosed Moderate to Severe Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT04999228 |
Interventions
- Infliximab (Drug)
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. - Corticosteroids (Drug)
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.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital of Fudan University | Shanghai, Shanghai Municipality | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.