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Impact of Infliximab in Fistulizing Crohn's Disease on Health Care Resources (Study P04204)(TERMINATED)

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ClinicalTrials.gov Identifier: NCT00705471
Recruitment Status : Terminated (Study stopped prematurely due to enrolment challenges.)
First Posted : June 26, 2008
Last Update Posted : April 8, 2015
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment
Crohn Disease Biological: Infliximab

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

Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Infliximab Use in Fistulizing Crohn's Disease: Impact on Health Care Resources
Study Start Date : April 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Infliximab
U.S. FDA Resources

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.
Biological: Infliximab
None available in the protocol. This was a chart review study, therefore no Infliximab provided during the study.
Other Names:
  • Remicade
  • SCH 215596



Primary Outcome Measures :
  1. To quantify the impact of infliximab therapy on the Canadian healthcare resource utilization as expressed as incidence per year. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. To quantify the impact of infliximab therapy on healthcare resource utilization as expressed in Canadian dollars. [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00705471     History of Changes
Other Study ID Numbers: P04204
First Posted: June 26, 2008    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents