Combined Immunosuppression for Pediatric Crohn's Disease

• Status: Not yet recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized controlled trial to compare the efficacy and safety of infliximab and immunosuppressives therapy alone or in combination for pediatric Crohn's disease.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Fudan University
• Treatments: Immunosuppressive Agents; Infliximab

Criteria

Inclusion Criteria:

1. 2-18 years old

2. diagnosis of Crohn's Disease

3. 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

Exclusion Criteria:

1. history of biological agents targeting at tumor necrosis factor (TNF)

2. Crohn's Disease-related surgery

3. infections

4. tumors