Impact of Infliximab in Fistulizing Crohn's Disease on Health Care Resources (Study P04204)(TERMINATED)
This study has been terminated.
(Study stopped prematurely due to enrolment challenges.)
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: June 23, 2008
Last updated: April 30, 2014
Last verified: April 2014
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.
||Observational Model: Cohort
Time Perspective: Retrospective
||Infliximab Use in Fistulizing Crohn's Disease: Impact on Health Care Resources
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2007 (Final data collection date for primary outcome measure)
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.
This study population was chosen from a non-probability sample.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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).
- 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.
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No Contacts or Locations Provided
No publications provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 23, 2008
||April 30, 2014
||Canada: Health Canada
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 20, 2014
Digestive System Diseases
Inflammatory Bowel Diseases
Anti-Inflammatory Agents, Non-Steroidal
Central Nervous System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents