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Combined Immunosuppression for Pediatric Crohn's Disease

Recruiting
6 - 18 years of age
Both
Phase 4
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  • Simplified (AI rewritten)

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Overview

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.

Eligibility

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

Study details

Crohn Disease, Infliximab, Immunosuppression, Children, Only

NCT05043870

Children's Hospital of Fudan University

29 March 2025

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