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

Sponsors and Collaborators:	Schering-Plough Centocor, Inc.
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00705471

Purpose

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.

Condition	Intervention
Crohn Disease	Biological: Infliximab

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Infliximab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	Infliximab Use in Fistulizing Crohn's Disease: Impact on Health Care Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	42
Study Start Date:	April 2005
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.	Biological: Infliximab None available in the protocol. This was a chart review study, therefore no Infliximab provided during the study.

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04204
Study First Received:	June 23, 2008
Last Updated:	June 25, 2008
ClinicalTrials.gov Identifier:	NCT00705471
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Digestive System Diseases
Infliximab
Gastrointestinal Diseases
Crohn Disease

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Therapeutic Uses
Gastrointestinal Agents

Antirheumatic Agents
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009