Safety and Effectiveness of Infliximab in Slovakia When Used for Rheumatoid Arthritis (Study P04741)(COMPLETED)

NCT ID: NCT00724243

Last Updated: 2015-09-04

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

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-10-31

Brief Summary

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This study will gather information on the safety and efficacy of patients with rheumatoid arthritis (RA) who are starting treatment with infliximab for the first time. Patients will be treated in the usual manner according to local guidelines and normal clinical practice.

Detailed Description

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Local patients, diagnosed with RA at the National Institute of Rheumatic Diseases, Piestany, Slovakia, can participate, if their physicians have decided to treat the patient with infliximab. Registration for the trial will be done on a voluntary basis.

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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Rheumatoid Arthritis Patients in Slovakia

Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.

Infliximab

Intervention Type DRUG

Infliximab given in accordance with the local summary of product characteristics

Interventions

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Infliximab

Infliximab given in accordance with the local summary of product characteristics

Intervention Type DRUG

Other Intervention Names

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Remicade SCH 215596

Eligibility Criteria

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Inclusion Criteria

* Subject must have been given patient leaflet,
* Subject must not have ever received infliximab at the time of registration,
* Subject must be a good candidate for infliximab as per Summary of Product Characteristics
* Subject must sign the approved consent form

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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P04741

Identifier Type: -

Identifier Source: org_study_id

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