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Trial record 1 of 1 for:    NCT00273858
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Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis

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ClinicalTrials.gov Identifier: NCT00273858
Recruitment Status : Terminated (The study was terminated because at least one year follow-up was achieved for each patient and the achievement of 965 exposure years to the drug.)
First Posted : January 9, 2006
Results First Posted : July 28, 2011
Last Update Posted : September 12, 2011
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date January 4, 2006
First Posted Date January 9, 2006
Results First Submitted Date June 30, 2011
Results First Posted Date July 28, 2011
Last Update Posted Date September 12, 2011
Study Start Date March 2006
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 30, 2011)
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Month 24 ]
    Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
  • Number of Participants Who Discontinued Treatment [ Time Frame: Baseline up to Month 24 ]
  • Number of Participants by Reasons for Discontinuation of Treatment [ Time Frame: Baseline up to Month 24 ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00273858 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 8, 2011)
  • Change From Baseline in Health Assessment Questionnaire (HAQ) at 24 Month [ Time Frame: Baseline, Month 24 ]
    HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores as 'normal' (no difficulty=0), 'adequate' (some difficulty= 1), 'limited' (much difficulty=2), and 'unable to do' (=3) based on degree of difficulty they experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. HAQ total scores were expressed as overall mean score ranging from 0 to 3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; greater than 1=significant functional limitation.
  • Change From Baseline in Patient Global Assessment (PtGA) Visual Analog Scale (VAS) at 24 Month [ Time Frame: Baseline, Month 24 ]
    PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad.
  • Change From Baseline in Physician Global Assessment (PGA) VAS at 24 Month [ Time Frame: Baseline, Month 24 ]
    PGA was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity to 100 mm = worst disease activity possible.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date September 2011