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

Merck Sharp & Dohme LLC42 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Crohn Disease

Interventions

InfliximabBIOLOGICAL

None available in the protocol. This was a chart review study, therefore no Infliximab provided during the study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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). 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.

Outcomes

Primary Outcomes

To quantify the impact of infliximab therapy on the Canadian healthcare resource utilization as expressed as incidence per year.

Time frame: 1 year

Secondary Outcomes

To quantify the impact of infliximab therapy on healthcare resource utilization as expressed in Canadian dollars.

Time frame: 1 year

Data from ClinicalTrials.gov

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