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

NCT ID: NCT00705471

Last Updated: 2015-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-09-30

Brief Summary

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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.

Detailed Description

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

Conditions

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Crohn Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Infliximab

Intervention Type BIOLOGICAL

None available in the protocol. This was a chart review study, therefore no Infliximab provided during the study.

Interventions

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Infliximab

None available in the protocol. This was a chart review study, therefore no Infliximab provided during the study.

Intervention Type BIOLOGICAL

Other Intervention Names

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Remicade SCH 215596

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centocor, Inc.

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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P04204

Identifier Type: -

Identifier Source: org_study_id

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