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
Group Intervention Description Infliximab Infliximab Because 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
Name Time Method To quantify the impact of infliximab therapy on the Canadian healthcare resource utilization as expressed as incidence per year. 1 year
- Secondary Outcome Measures
Name Time Method To quantify the impact of infliximab therapy on healthcare resource utilization as expressed in Canadian dollars. 1 year