Clinical Trial: Study Evaluating Safety and Adherence to Treatment With Etanercept in Adults With Psoriatic Arthritis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Post-Marketing Surveillance For Safety And Adherence To Treatment Of Enbrel In Adults With Psoriatic Arthritis In Belgium

Brief Summary: The aim of this study is to evaluate if the data obtained in controlled clinical trials are confirmed when Enbrel is used in usual clinical practice in Belgium according to local reimbursement criteria.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome:

  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1 [ Time Frame: Baseline up to Year 1 ]
    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2 [ Time Frame: Year 1 up to Year 2 ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
  • Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3 [ Time Frame: Year 2 up to Year 3 ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital

    Original Primary Outcome: at least one serious adverse event [ Time Frame: one year ]

    Current Secondary Outcome:

    • Percentage of Participants With at Least 1 Adverse Event (AE) Per Year [ Time Frame: Baseline up to Year 6 ]
      An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
    • Incidence of Adverse Events and Serious Adverse Events Per Participant-Year [ Time Frame: Baseline up to Month 6, 12, 18, 30, 42, 54, 66 ]
      Participant-Year estimated by calculating all of the years that participants in a study were followed (mean study drug exposure duration multiplied by safety set population). Incidence calculated as AEs or SAEs divided by Participant-Year multiplied by 100. Incidence of AEs and SAEs were broken down by each follow-up time period.
    • Percentage of Participants With Psoriatic Arthritis (PsA) Receiving Enbrel Who Stayed on the Treatment [ Time Frame: Baseline up to Month 78 ]
    • Number of Joints With Active Arthritis [ Time Frame: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78 ]
      Numbers of joints with active arthritis were defined as joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness.
    • Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Participant Evaluation [ Time Frame: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78 ]
      Quality of life for oligo-articular type arthritis was assessed on a 11-point Numerical Rating Scale (NRS) ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per participant was evaluated.
    • Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Physician Evaluation [ Time Frame: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78 ]
      Quality of life for oligo-articular type arthritis was assessed on a 11-point NRS ranging from 1 (best health status) to 10 (worst health status). NRS for the most affected joint as per physician was evaluated.
    • Quality of Life Assessed by Health Assessment Questionnaire (HAQ) For Poly-Articular Type Psoriatic Arthritis (PsA) [ Time Frame: Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78 ]
      HAQ is a 20 item questionnaire to measure functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 items grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. Total score range 0-60, higher score indicating greater functional limitations.


    Original Secondary Outcome: number of events per patient-year broken down by follow-up time, the percentage of patients that stay on a treatment, effect of Enbrel on number of jointswith active arthritis and quality of life [ Time Frame: one year ]

    Information By: Pfizer

    Dates:
    Date Received: July 10, 2009
    Date Started: October 2004
    Date Completion:
    Last Updated: March 27, 2013
    Last Verified: March 2013