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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 20 April 2015
Main ID:  NCT00705471
Date of registration: 23/06/2008
Prospective Registration: No
Primary sponsor: Merck Sharp & Dohme Corp.
Public title: Impact of Infliximab in Fistulizing Crohn's Disease on Health Care Resources (Study P04204)(TERMINATED)
Scientific title: Infliximab Use in Fistulizing Crohn's Disease: Impact on Health Care Resources
Date of first enrolment: April 2005
Target sample size: 42
Recruitment status: Terminated
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Retrospective  
Phase:  N/A
Countries of recruitment
Key inclusion & exclusion criteria

Inclusion Criteria:

- Treatment with infliximab for fistulizing CD.

- Administration of at least one infliximab infusion >=12 months before the chart

- 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

Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn Disease
Biological: Infliximab
Primary Outcome(s)
To quantify the impact of infliximab therapy on the Canadian healthcare resource utilization as expressed as incidence per year. [Time Frame: 1 year]
Secondary Outcome(s)
To quantify the impact of infliximab therapy on healthcare resource utilization as expressed in Canadian dollars. [Time Frame: 1 year]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Centocor, Inc.
Ethics review
Results available:
Date Posted:
Date Completed:
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