Comparing two treatment approaches for children with ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Children's Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Cui fang Zheng
• Email: zhengcuifang2@126.com
• Phone: 8615221881022

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.