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

This study has been terminated.

(Study stopped prematurely due to enrolment challenges.)

Sponsor:

Collaborator:

Centocor, Inc.

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00705471

First received: June 23, 2008

Last updated: June 25, 2008

Last verified: June 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	June 23, 2008
Last Updated Date	June 25, 2008
Start Date ^ICMJE	April 2005
Primary Completion Date	September 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 25, 2008)	To quantify the impact of infliximab therapy on the Canadian healthcare resource utilization as expressed as incidence per year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00705471 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 25, 2008)	To quantify the impact of infliximab therapy on healthcare resource utilization as expressed in Canadian dollars. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Impact of Infliximab in Fistulizing Crohn's Disease on Health Care Resources (Study P04204)
Official Title ^ICMJE	Infliximab Use in Fistulizing Crohn's Disease: Impact on Health Care Resources
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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	The charts of subjects with fistulizing CD to 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.
Condition ^ICMJE	Crohn Disease
Intervention ^ICMJE	Biological: Infliximab None available in the protocol. This was a chart review study, therefore no Infliximab provided during the study. Other Names: Remicade SCH 215596
Study Group/Cohort (s)	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. Intervention: Biological: Infliximab
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	42
Completion Date	September 2007
Primary Completion Date	September 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00705471
Other Study ID Numbers ^ICMJE	P04204
Has Data Monitoring Committee	No
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Centocor, Inc.
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	June 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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