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Sponsors and Collaborators: |
Schering-Plough Centocor, Inc. |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00705471 |
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 |
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Crohn Disease |
Biological: Infliximab |
Study Type: | Observational |
Study Design: | Cohort, Retrospective |
Official Title: | Infliximab Use in Fistulizing Crohn's Disease: Impact on Health Care Resources |
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 |
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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.
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Biological: Infliximab
None available in the protocol. This was a chart review study, therefore no Infliximab provided during the study.
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This study population was chosen from a non-probability sample.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
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 History of Changes |
Health Authority: | Canada: Health Canada |
Anti-Inflammatory Agents Crohn's Disease Ileitis Gastrointestinal Diseases Infliximab Enteritis Inflammatory Bowel Diseases |
Intestinal Diseases Ileal Diseases Digestive System Diseases Crohn Disease Gastroenteritis Antirheumatic Agents |
Anti-Inflammatory Agents Ileitis Gastrointestinal Diseases Infliximab Enteritis Gastrointestinal Agents Inflammatory Bowel Diseases Intestinal Diseases |
Ileal Diseases Pharmacologic Actions Digestive System Diseases Therapeutic Uses Crohn Disease Antirheumatic Agents Gastroenteritis Dermatologic Agents |