Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

880 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2010-07-31

Brief Summary

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This is a Phase 4 open label, non-interventional, multi-center study to evaluate the safety of Enbrel (etanercept) treatment in patients receiving etanercept 25mg sc twice weekly or 50mg of etanercept once weekly. The improvement of health-related quality of life will also be evaluated.

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Detailed Description

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Patients already prescribed to receive etanercept for the first time for treatment of Rheumatoid Arthritis, Ankylosing Spondylitis or Psoriatic Arthritis according to the Summary of Product Characteristics (SmPC).

Patients have been recruited sequentially based on eligibility criteria up to the number limit assigned to each site.

Conditions

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Ankylosing Spondylitis Arthritis, Psoriatic Arthritis, Rheumatoid Spondylitis, Ankylosing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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etanercept

Patients already prescribed to receive etanercept for the first time for treatment of Rheumatoid Arthritis, Ankylosing Spondylitis or Psoriatic Arthritis according to the Summary of Product Characteristics (SmPC).

There is no Intervention. The study is observational.

Intervention Type OTHER

The study is observational and the prescription follows the SmPC of etanercept.

Interventions

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There is no Intervention. The study is observational.

The study is observational and the prescription follows the SmPC of etanercept.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older at time of consent
* Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis or has a diagnosis of ankylosing spondylitis or psoriatic arthritis, as determined by the doctor
* Provides informed consent
* Demonstrate a negative serum or urine pregnancy test prior to administration of etanercept. Sexually active women participating in the study must use a medically acceptable form of contraception.
* Patients already prescribed etanercept according to approved labelling

Exclusion Criteria

* Has hypersensitivity to etanercept
* Has sepsis or risk of sepsis. Treatment with etanercept should not be initiated in patients with active infections (ie. hepatitis C, hepatitis B, active TBC)
* Is pregnant or breast-feeding
* Has significant concurrent medical diseases including, uncompensated congestive heart failure, myocardial infarction within 12 months, unstable angina pectoris, or history of human immunodeficiency virus (HIV) infection, immunodeficiency syndromes, or central nervous system (CNS) demyelinating events suggestive of multiple sclerosis
* Has a history of confirmed blood dyscrasias
* Received any live (attenuated) vaccines within 4 weeks of screening visit

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No