Program Extension of Real Life Dosing of Remicade in Austria for Crohn's Disease (Study P04052)(COMPLETED)

NCT ID: NCT00724958

Last Updated: 2015-10-02

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

COMPLETED

Total Enrollment

348 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-12-31

Study Completion Date

2010-07-31

Brief Summary

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The current observational program was determined to collect data on the real life dosing regimen of Remicade in patients with Crohn's disease (CD) in the hospital and non-hospital setting.

Detailed Description

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This study population was chosen from a non-probability sample

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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Remicade

Subjects with active luminal and/or fistulizing CD in the hospital or non-hospital setting.

Infliximab

Intervention Type BIOLOGICAL

Not specified in the protocol.

Interventions

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Infliximab

Not specified in the protocol.

Intervention Type BIOLOGICAL

Other Intervention Names

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Remicade SCH 215596

Eligibility Criteria

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Inclusion Criteria

* Subjects with active luminal and/or fistulizing CD.

Exclusion Criteria

* Per summary of product characteristics.
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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P04052

Identifier Type: -

Identifier Source: org_study_id

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