- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00705471
Impact of Infliximab in Fistulizing Crohn's Disease on Health Care Resources (Study P04204)(TERMINATED)
April 7, 2015 updated by: Merck Sharp & Dohme LLC
Infliximab Use in Fistulizing Crohn's Disease: Impact on Health Care Resources
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.
Study Overview
Detailed Description
This study population was chosen from a non-probability sample.
Study Type
Observational
Enrollment (Actual)
42
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
None available in the protocol.
This was a chart review study, therefore no Infliximab provided during the study.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To quantify the impact of infliximab therapy on the Canadian healthcare resource utilization as expressed as incidence per year.
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To quantify the impact of infliximab therapy on healthcare resource utilization as expressed in Canadian dollars.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (Actual)
September 1, 2007
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
June 23, 2008
First Submitted That Met QC Criteria
June 25, 2008
First Posted (Estimate)
June 26, 2008
Study Record Updates
Last Update Posted (Estimate)
April 8, 2015
Last Update Submitted That Met QC Criteria
April 7, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P04204
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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