Actively Recruiting

Phase 4
Age: 6Years - 18Years
All Genders
NCT05043870

Combined Immunosuppression for Pediatric Crohn's Disease

Led by Children's Hospital of Fudan University · Updated on 2026-03-19

128

Participants Needed

1

Research Sites

220 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Combined Immunosuppression for Pediatric Crohn's Disease

Who Can Participate

Age: 6Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 6 and 18 years
  • Diagnosis of Crohn's Disease
  • Pediatric Crohn's Disease Activity Index (PCDAI) greater than 30 or Simple Endoscopic Score for Crohn Disease (SES-CD) greater than 10 before treatment
  • Receiving exclusive enteral nutrition or corticosteroids as first-line treatment with PCDAI greater than 10 or SES-CD greater than or equal to 3 after treatment
  • Patient or legal guardian has signed informed consent
Not Eligible

You will not qualify if you...

  • History of biological agents targeting tumor necrosis factor (TNF)
  • Previous Crohn's Disease-related surgery
  • Presence of infections
  • Presence of tumors

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 201102

Actively Recruiting

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Research Team

L

Lin Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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