Status:
TERMINATED
Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Ankylosing Spondylitis
Arthritis, Psoriatic
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
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 Characteri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
880 Patients enrolled
Trial Details
Trial ID
NCT00273858
Start Date
March 1 2006
End Date
July 1 2010
Last Update
September 12 2011
Active Locations (9)
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1
Pfizer Investigational Site
Thessaloniki, Asvestohori, Greece, 570 10
2
Pfizer Investigational Site
Athens, Maroussi, Greece, 145 61
3
Pfizer Investigational Site
Athens, Greece, 115 26
4
Pfizer Investigational Site
Athens, Greece, 115 27