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Top-down Infliximab Study in Kids With Crohn's Disease

NCT02517684 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-03-05

No results posted yet for this study

Summary

The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab (IFX) and azathioprine (AZA) at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and AZA or exclusive enteral nutrition (EEN) and AZA, in moderate-to-severe pediatric Crohn's disease (CD) patients.

Conditions

Interventions

DRUG

Infliximab

DRUG

Prednisolone

OTHER

Exclusive enteral nutrition

DRUG

Azathioprine

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Hospira, now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Erasmus Medical Center

    lead OTHER

Principal Investigators

  • Lissy de Ridder, MD PhD · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2019-12-31
Completion
2024-01-31

Countries

  • Belgium
  • Finland
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT02517684 on ClinicalTrials.gov