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

Last updated on October 5, 2018

FOR MORE INFORMATION
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.
Show details

- 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.
Show details

- 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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Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis
Open Label Study To Evaluate The Safety Profile And The Quality Of Life In Patients Receiving Etanercept For The Treatment Of Rheumatoid Arthritis, Ankylosing Spondylitis And Psoriatic Arthritis
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Rheumatoid Arthritis Patients, Psoriatic Arthritis Patients, Ankylosing Spondylitis Patients
  • Ankylosing Spondylitis
  • Arthritis, Psoriatic
  • Arthritis, Rheumatoid
  • Spondylitis, Ankylosing
Other: There is no Intervention. The study is observational.
The study is observational and the prescription follows the SmPC of etanercept.
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).
Intervention: Other: There is no Intervention. The study is observational.
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
880
July 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
 
NCT00273858
0881A-101695
B1801106
No
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
September 2011

FOR MORE INFORMATION

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