Combined Immunosuppression for Pediatric Crohn's Disease

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

Keywords

ClinConnect Summary

This clinical trial is studying how well a medication called infliximab, either on its own or combined with other treatments, works for children with Crohn's disease. Crohn's disease is a condition that causes inflammation in the digestive system, leading to symptoms like stomach pain and diarrhea. The trial aims to find out which treatment approach is more effective and safer for kids aged 6 to 18 who have been diagnosed with this condition.

To be eligible for the trial, children need to have a specific level of disease activity as measured by certain scoring systems, meaning their condition is significant enough that treatment is necessary. Participants will receive one of the treatment options and be monitored for their health and any side effects. It's important to note that children with a history of certain previous treatments or surgeries related to Crohn's disease, as well as those with infections or tumors, cannot participate. Overall, this trial is a way to explore better treatment options for young patients dealing with Crohn's disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 6-18 years old
• • 2. diagnosis of Crohn's Disease
• • 3. Pediatric Crohn's disease Activity Index (PCDAI)\>30 or The Simple Endoscopic Score for Crohn Disease (SES-CD) \>10 before treatment
• • 4. receiving exclusive enteral nutrition or corticosteroids as first-line treatment, Pediatric Crohn's disease Activity Index (PCDAI)\>10 or The Simple Endoscopic Score for Crohn Disease (SES-CD)≥3 after exclusive enteral nutrition or corticosteroids
• • 5. The patient or legal guardian sign the informed consent documents
• Exclusion Criteria:
• • 1. history of biological agents targeting at tumor necrosis factor (TNF)
• • 2. Crohn's Disease-related surgery
• • 3. infections
• • 4. tumors