RecruitingPhase 4NCT05043870
Combined Immunosuppression for Pediatric Crohn's Disease
Combination Therapy of Infliximab and Immunosuppressives for Pediatric Crohn's Disease
Sponsor
Children's Hospital of Fudan University
Enrollment
128 participants
Start Date
Oct 10, 2022
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 6 YearsMax Age: 18 Years
Inclusion Criteria5
- years old
- diagnosis of Crohn's Disease
- Pediatric Crohn's disease Activity Index (PCDAI)\>30 or The Simple Endoscopic Score for Crohn Disease (SES-CD) \>10 before treatment
- 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
- The patient or legal guardian sign the informed consent documents
Exclusion Criteria4
- history of biological agents targeting at tumor necrosis factor (TNF)
- Crohn's Disease-related surgery
- infections
- tumors
Interventions
DRUGInfliximab 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
DRUGInfliximab
the infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05043870
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