Top Down Versus Step up in Pediatric Ulcerative Colitis

Launched by CHILDREN'S HOSPITAL OF FUDAN UNIVERSITY · Aug 5, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the best way to treat children and teens aged 6 to 18 who have been newly diagnosed with moderate to severe Ulcerative Colitis (UC), a condition that causes inflammation in the intestines. Researchers want to find out whether starting treatment with a biologic medication called infliximab (IFX) right away (known as the "Top Down" approach) is more effective than starting with corticosteroids and then switching to stronger medications if needed (the "Step-Up" approach). The main goal is to see how well each treatment helps heal the intestines after 12 weeks, and they will also look at how many patients have relapses or stay in remission over the following year.

To participate in this trial, children must be newly diagnosed with moderate to severe UC and be between 6 and 18 years old. Those with mild UC or who have already received treatment for their condition will not be eligible. Participants will be randomly assigned to one of the two treatment groups, and they can expect regular check-ups to monitor their progress and response to the treatment. This study is currently recruiting participants, and it aims to provide valuable insights that could improve care for young patients with UC in the future.

Gender

ALL

Eligibility 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