Remicade® Crohn's Disease Registry Across Canada (Study P02793)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

556 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-02-28

Study Completion Date

2007-09-30

Brief Summary

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This registry is a multi-center, prospective, observational program that will gather and analyze data on subjects with Crohn's disease being treated with Remicade® as per approved product monograph in Canada. In contrast to a controlled clinical trial, there is no imposed experimental intervention and treatment with Remicade® is determined solely by the subject's physicians. Thus, the data captured and reported in this registry will reflect a "real world" approach to the treatment of Crohn's disease with Remicade®.

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Detailed Description

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Subjects will be selected for this registry using a non-probability sampling method.

Conditions

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Crohn's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects receiving Remicade

Crohn's disease subjects receiving Remicade® per Product Monograph.

Data collection post infusion

Intervention Type OTHER

Interventions

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Data collection post infusion

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient was given the Patient Information Brochure; AND,
* Patient has never been treated with Remicade® (patient is naïve to Remicade® at the time of registration); AND,
* Patient is a good candidate to receive Remicade® as per the product monograph; AND,
* Patient has agreed to complete the Patient Diary for one week prior to each visit in the registry; AND,
* Patient has signed the approved consent form.