Study Stopped
Study stopped prematurely due to enrolment challenges.
Impact of Infliximab in Fistulizing Crohn's Disease on Health Care Resources (Study P04204)(TERMINATED)
Infliximab Use in Fistulizing Crohn's Disease: Impact on Health Care Resources
1 other identifier
observational
42
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2005
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 23, 2008
CompletedFirst Posted
Study publicly available on registry
June 26, 2008
CompletedApril 8, 2015
April 1, 2015
2.4 years
June 23, 2008
April 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
To quantify the impact of infliximab therapy on the Canadian healthcare resource utilization as expressed as incidence per year.
1 year
Secondary Outcomes (1)
To quantify the impact of infliximab therapy on healthcare resource utilization as expressed in Canadian dollars.
1 year
Study Arms (1)
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.
Interventions
None available in the protocol. This was a chart review study, therefore no Infliximab provided during the study.
Eligibility Criteria
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.
You may qualify if:
- Treatment with infliximab for fistulizing CD.
- Administration of at least one infliximab infusion \>=12 months before the chart review.
- years of age or over (men and women).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merck Sharp & Dohme LLClead
- Centocor, Inc.collaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2008
First Posted
June 26, 2008
Study Start
April 1, 2005
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
April 8, 2015
Record last verified: 2015-04