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

NCT00273858

Last updated date
Study Location
Pfizer Investigational Site
Thessaloniki, Asvestohori, 570 10, Greece
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ankylosing Spondylitis, Arthritis, Psoriatic, Arthritis, Rheumatoid, Spondylitis, Ankylosing
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

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Ankylosing Spondylitis, Arthritis, Psoriatic, Arthritis, Rheumatoid, Spondylitis, AnkylosingStudy Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis
NCT00273858
  1. Thessaloniki, Asvestohori
  2. Athens, Maroussi
  3. Athens,
  4. Athens,
  5. Athens,
  6. Athens,
  7. Karditsa,
  8. Larissa,
  9. Thessaloniki,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis
Official Title 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
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 once weekly. The improvement of health-related quality of life will also be evaluated.
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 Characteristics (SmPC).

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

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Rheumatoid Arthritis Patients, Psoriatic Arthritis Patients, Ankylosing Spondylitis Patients
Condition
  • Ankylosing Spondylitis
  • Arthritis, Psoriatic
  • Arthritis, Rheumatoid
  • Spondylitis, Ankylosing
Intervention Other: There is no Intervention. The study is observational.
The study is observational and the prescription follows the SmPC of etanercept.
Study Groups/Cohorts 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: June 30, 2011)
880
Original Enrollment
 (submitted: January 4, 2006)
400
Actual Study Completion Date July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT00273858
Other Study ID Numbers 0881A-101695
B1801106
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date September 2011