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Efficacy and Safety of Two Regimens of Maintenance Therapy in Children With Crohn Disease

NCT01559142 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-04-04

No results posted yet for this study

Summary

The aim of the study is confirmation of efficacy of induction therapy with three doses of infliximab In patients with Crohn disease aged 7-17 years, and comparison of efficacy and safety of two regiment of maintenance therapy:

1. Infliximab with immunomodulation
2. Infliximab alone

Conditions

  • Crohn Disease

Interventions

DRUG

Infliximab with azathioprine (IIFX + AZA)

Infliximab with azathioprine during whole one year study

DRUG

Infliximab (IFX alone)

Infliximab continuously; azathioprine stopped in 26 week

Sponsors & Collaborators

  • Children's Memorial Health Institute, Poland

    lead OTHER

Principal Investigators

  • Jaroslaw Kierkus, MD PhD · The Children's Memorial Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2012-04-30
Completion
2012-12-31

Countries

  • Poland

Study Locations

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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 NCT01559142 on ClinicalTrials.gov