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

Crohn Disease Clinical Trial

Official title:

Infliximab Use in Fistulizing Crohn's Disease: Impact on Health Care Resources

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00705471
• Other study ID #: P04204
• Status: Terminated
• Phase: N/A
• First received: June 23, 2008
• Last updated: April 7, 2015
• Start date: April 2005
• Est. completion date: September 2007

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Crohn Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Centocor, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To quantify the impact of infliximab therapy on the Canadian healthcare resource utilization as expressed as incidence per year.		1 year	No
Secondary	To quantify the impact of infliximab therapy on healthcare resource utilization as expressed in Canadian dollars.		1 year	No