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Clinical Trials in China / NCT05043870
Recruiting Phase 4

Combined Immunosuppression for Pediatric Crohn's Disease

NCT05043870 · tracked via the Priya Life Science China tracker
Sponsor
Children's Hospital of Fudan University
Phase
Phase 4
Started
2022-10-10
Last updated
2026-03-19

Condition(s) studied

Crohn DiseaseInfliximabImmunosuppressionChildren, Only

Investigational drug(s) / intervention(s)

Infliximab and immunosuppressivesInfliximab →

Infliximab and immunosuppressives: the infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks, the immunomodulatory agent was azathioprine 1-2mg/kg per day or methotrexate 10-25 mg/m2 week

Infliximab: the infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks

Study 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
18 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • clinical remission — week 54
    The clinical remission rate at week 54
  • endoscopic remission — week 54
    The endoscopic remission rate at week 54

Trial sites (1)

FacilityCityRegionStatus
Children's Hospital of Fudan University Shanghai Shanghai Municipality Recruiting

On this site

📄 Remicade (infliximab) drug profile →

More Children's Hospital of Fudan University trials in China

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PK/PD of Ceftazidime Avitbatan Sodium in Children With Severe Infection Recruiting
YTS109 in Pediatric Relapsed/Refractory Autoimmune Diseases Starting soon
Development of an Early Warning Model for Intensive Care Unit-Acquired Weakness in Mechanically Ventilated Children Enrolling by invitation
Interactive Massage Intervention in Toddlers With Autism Spectrum Disorder Recruiting

Other trials for the same condition

Prospective Cohort Establishment and Clinical Observation of Children With Crohn's Disease Active, not recruiting
Efficacy and Safety of CDED With Anti-TNF-α Biologics in Crohn's Disease Starting soon
Comparing Endoscopic Strictureplasty vs. Balloon Dilation in Crohn's Disease Strictures Recruiting
Effect of Acupuncture on Mild to Moderate Active Crohn's Disease Recruiting
Fecal Microbiota Transplantation in Pediatric Crohn's Disease Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05043870 on ClinicalTrials.gov ↗ ← All trials in China