Comparing two treatment approaches for children with ulcerative colitis
First-line Treatment With Infliximab Versus Corticosteroids in Children With Newly Diagnosed Moderate to Severe Ulcerative Colitis
This study is testing whether a new medicine called infliximab works better than traditional steroids for children with moderate to severe ulcerative colitis to help them feel better and heal faster.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Drugs / interventions | infliximab |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT04999228 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of two treatment strategies for pediatric patients aged 6 to 18 with newly diagnosed moderate to severe ulcerative colitis. Participants will be randomly assigned to receive either infliximab (a biologic agent) or corticosteroids, with the aim of achieving mucosal healing and assessing clinical response at various time points. The study will compare the mucosal healing rates at week 12, as well as relapse rates and sustained remission durations over one year. This approach seeks to determine whether early biologic therapy is more beneficial than a gradual step-up treatment strategy.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 18 who have been newly diagnosed with moderate to severe ulcerative colitis.
Not a fit: Patients with mild disease activity or those who have previously received corticosteroids or biologic agents for ulcerative colitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for pediatric ulcerative colitis, potentially reducing the need for surgery.
How similar studies have performed: While the specific comparison of these two treatment strategies has not been previously studied, early use of biologics has shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai, Shanghai Municipality
- Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Cui fang Zheng
- Email: zhengcuifang2@126.com
- Phone: 8615221881022
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.