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Impact of Infliximab in Fistulizing Crohn's Disease on Health Care Resources (Study P04204)(TERMINATED)

Terminated
Conditions
Crohn Disease
Interventions
Biological: Infliximab
Registration Number
NCT00705471
Lead Sponsor
Merck Sharp & Dohme LLC
Brief Summary

A multi-centre retrospective review of fistulizing Crohn's disease (CD) patient charts will capture data to measure health care resource utilization associated with the use of Infliximab for treatment of CD. Three health science centres/hospitals from Ontario are targeted to participate in the study, each site is expected to provide 30-40 patient charts with a target of 108 charts total.

Detailed Description

This study population was chosen from a non-probability sample.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
42
Inclusion Criteria
  • Treatment with infliximab for fistulizing CD.
  • Administration of at least one infliximab infusion >=12 months before the chart review.
  • 18 years of age or over (men and women).
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Exclusion Criteria
  • Subjects not followed for a full year after their first infusion of infliximab.
  • Subjects not followed for a full year prior to their first infusion of infliximab.
  • Subjects who had participated in clinical studies during the data collection timeframe.
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
InfliximabInfliximabBecause of the difficulty of finding subjects with exactly the same disease severity, information will be recorded for the time period for up to three years before and for one year after their initial infliximab infusion for comparison of health care costs and utilization prior to infliximab and post infliximab use.
Primary Outcome Measures
NameTimeMethod
To quantify the impact of infliximab therapy on the Canadian healthcare resource utilization as expressed as incidence per year.1 year
Secondary Outcome Measures
NameTimeMethod
To quantify the impact of infliximab therapy on healthcare resource utilization as expressed in Canadian dollars.1 year
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