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

Last updated on April 1, 2019

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Study Location
Pfizer Investigational Site
Thessaloniki, Asvestohori, 570 10 Greece
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ankylosing Spondylitis, Psoriatic Arthritis, Rheumatoid Arthritis, Ankylosing Spondylitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT00273858
Pfizer
Terminated
Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis

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