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Combined Immunosuppression for Pediatric Crohn's Disease

NCT05043870 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-03-19

No results posted yet for this 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.

Conditions

  • Crohn Disease
  • Infliximab
  • Immunosuppression
  • Children, Only

Interventions

DRUG

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

DRUG

Infliximab

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

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Ying Huang · Children's Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-10
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05043870 on ClinicalTrials.gov