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Recruiting NCT05043870

Combined Immunosuppression for Pediatric Crohn's Disease

Phase IV Interventional Crohn Disease Infliximab Immunosuppression Children, Only

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Infliximab and immunosuppressives, Infliximab.
Who it may be relevant to
Registry conditions: Crohn Disease, Infliximab, Immunosuppression, Children, Only. Basic parameters: 6 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Combination Therapy of Infliximab and Immunosuppressives for Pediatric Crohn's Disease

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.

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

Primary outcome measures

  • clinical remission [Time frame: week 54]
  • endoscopic remission [Time frame: week 54]
Secondary outcome measures (1)
  • Pediatric Crohn's disease Activity Index score [Time frame: week0, week2, week6, week14, week22, week30, week38, week46, week54]

Eligibility criteria

Inclusion criteria

  • 6-18 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 criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Children's Hospital of Fudan University — Shanghai

Identifiers

NCT: NCT05043870 · Combined therapy in CD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗