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Infliximab Top-down in Pediatric Crohn

NCT01880307 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2015-07-02

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Azathioprine

DRUG

Infliximab

DRUG

Prednisolon

Sponsors & Collaborators

  • University of Roma La Sapienza

    collaborator OTHER

  • Universitair Ziekenhuis Brussel

    collaborator OTHER

  • Erasmus Medical Center

    lead OTHER

Principal Investigators

  • Lissy Ridder, de, 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
2013-01-31
Primary Completion
2014-12-31

Countries

  • Italy
  • 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 NCT01880307 on ClinicalTrials.gov