Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)(COMPLETED)

NCT ID: NCT00725621

Last Updated: 2015-09-03

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

516 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-03-31

Study Completion Date

2010-07-31

Brief Summary

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This is a prospective, open-label, 1-arm, multicenter observational study to determine the average Remicade dosage and time span between 9 infusions in subjects with rheumatoid arthritis (RA)

Detailed Description

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

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Remicade

Patients with severe RA (indication according to Austrian labeling) will receive Remicade induction therapy consisting of three Remicade infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of another maximal 6 infusions. Remicade induction and maintenance therapy doses and intervals will be at the discretion of the physicians.

Infliximab

Intervention Type BIOLOGICAL

Remicade induction therapy consisting of three Remicade infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of another maximal 6 infusions given in doses and intervals due to discretion of physicians.

Interventions

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Infliximab

Remicade induction therapy consisting of three Remicade infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of another maximal 6 infusions given in doses and intervals due to discretion of physicians.

Intervention Type BIOLOGICAL

Other Intervention Names

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Remicade SCH 215596

Eligibility Criteria

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Inclusion Criteria

* Severe RA (indication according to Austrian labeling).

Exclusion Criteria

* According to Summary of Product Characteristics (SPC).
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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P03756

Identifier Type: -

Identifier Source: org_study_id

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