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Trial record 1 of 1 for:    NCT00127842
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REPArE: Rating Evaluations in Psoriatic Arthritis (PsA) With Etanercept (Enbrel®)

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ClinicalTrials.gov Identifier: NCT00127842
Recruitment Status : Completed
First Posted : August 9, 2005
Results First Posted : April 24, 2014
Last Update Posted : April 24, 2014
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE August 5, 2005
First Posted Date  ICMJE August 9, 2005
Results First Submitted Date  ICMJE November 4, 2010
Results First Posted Date  ICMJE April 24, 2014
Last Update Posted Date April 24, 2014
Study Start Date  ICMJE August 2005
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2014)
Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI [ Time Frame: Baseline and 24 months ]
The HAQ DI is a questionnaire which measures functional status in patients with psoriatic arthritis. The questionnaire addresses health-related quality of life issues related to psoriatic arthritis such as dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.
Original Primary Outcome Measures  ICMJE
 (submitted: August 5, 2005)
Describe long term effectiveness of Enbrel® in subjects with PsA as measured by HAQDI
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2014)
  • Change From Baseline to Month 24 in the Health and Labour Questionnaire (HLQ) Absence From Work Module [ Time Frame: Baseline and 24 months ]
    The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The absence from work module asks participants to indicate how many days in the past 2 weeks they missed work due to health problems. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.
  • Change From Baseline to Month 24 in the HLQ Reduced Productivity at Paid Work Module [ Time Frame: Baseline and Month 24 ]
    The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. In the reduced productivity at work module participants were asked to estimate the number of additional hours required to compensate for production losses due to illness on working days over the past 2 weeks. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.
  • Change From Baseline to Month 24 in the HLQ Unpaid Labour Production Module [ Time Frame: Baseline and month 24 ]
    The HLQ collects quantitative data on the relation between illness and treatment and work performance. The instrument is divided into 4 modules to collect data about absence from work, reduced productivity at paid work, unpaid labor production and impediments to paid and unpaid labor. The Unpaid Labour Production Module assesses the amount of hours of unpaid work (including household work, shopping, caring for children and odd jobs around the house), normally performed by the participant, that were taken over by other members of the household, family or friends (unpaid help), and/or by paid workers due to health problems of the participant. Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.
  • Change From Baseline to Month 24 in the HLQ Impediments to Paid and Unpaid Labour Module [ Time Frame: Baseline and month 24 ]
    In the HLQ impediments to paid and unpaid labor module participants were asked "Were you hindered by health problems at your paid work over the past two weeks?" and answered according to the following: 'no not at all = 0', 'yes, a little = 1', 'yes, very = 2'. Participants were also asked whether they had performed 4 unpaid activities (household work, shopping, odd jobs / chores, and childcare), and answered according to the following: Did do, hindered = 1; Did do, not hindered = 0; Did not do, due to health problems = 2; Did not do, due to other reasons = 0. The aggregated score ranges from 0 (no impediments) to 8 (unable to do any of the surveyed activities). Change from Baseline was calculated as the Baseline value - Month 24 value. A positive change from Baseline value indicates improvement.
  • Change From Baseline to Month 24 in the Physician Global Assessment [ Time Frame: Baseline and month 24 ]
    The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites). Change from Baseline was calculated as Baseline value - Month 24 value. A positive change from Baseline indicates improvement.
  • Percent Change From Baseline to Month 24 in Physician Global Assessment [ Time Frame: Baseline and Month 24 ]
    The physician global assessment of disease activity asks the physician to assess how the participant is doing since their last visit on a scale from 1 (very good, asymptomatic, no limitations in normal activities) to 5 (very poor, severe symptoms that are intolerable, inability to carry out all normal activites). Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value * 100. A positive change from Baseline indicates improvement.
  • Change From Baseline to Month 24 in Patient Global Assessment [ Time Frame: Baseline and Month 24 ]
    The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). Change from Baseline was calculated as Baseline value - Month 24 value. A positive change from Baseline indicates improvement.
  • Percent Change From Baseline to Month 24 in Patient Global Assessment [ Time Frame: Baseline and month 24 ]
    The patient global assessment of disease activity is a 5-point scale that asks how the participant is doing since their last visit with regard to their rheumatoid arthritis. Participants answer on a scale from 1 (very good, asymptomatic, no limitation in normal activites) to 5 (very poor, very severe symptoms that are intolerable, inability to perform all normal activites). Percent change from Baseline was calculated as (Baseline value - Month 24 value) / Baseline value * 100. A positive change from Baseline indicates improvement.
  • Percentage of Participants With Improvement of ≥ 75 Percent From Baseline to Month 24 in the Psoriasis Activity and Severity Index (PASI) [ Time Frame: Baseline and Month 24 ]
    The PASI was is a method for quantifying the intensity of psoriasis, and for evaluating its improvement with treatment. This index is based on the quantitative assessment of three typical signs of psoriatic lesions: erythema, infiltration, and desquamation, combined with the skin surface area involvement. The index has a range from 0.0 to 72.0, with higher scores indicating worse psoriasis.
  • Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Month 24 [ Time Frame: Baseline and Month 24 ]
    Psoriatic Arthritis Response Criteria response is defined as improvement from Baseline in at least 2 of 4 criteria, one of which must be joint pain /tenderness or swelling and no worsening in any of the 4 following criteria: • Joint Pain/Tenderness score: Physician assessment of 78 joints for pain/tenderness on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234, with higher scores indicating more severe disability; • Joint Swelling score: Physician assessment of 78 joints for swelling on a scale from 0 (none) to 3 (severe) with a total score ranging from 0 to 234 with higher scores indicating more severe disability; • Patient global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor); • Physician global assessment of disease activity: Measured on a 5-point scale from 1 (very good) to 5 (very poor).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2005)
Describe long term productivity of Enbrel® in subjects with PsA in Canadian clinical practice
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE REPArE: Rating Evaluations in Psoriatic Arthritis (PsA) With Etanercept (Enbrel®)
Official Title  ICMJE Rating Evaluations in Psoriatic Arthritis (PsA) With Enbrel®
Brief Summary The overall objective of the study was to describe the long-term effectiveness and safety of etanercept in patients with psoriatic arthritis in a Canadian clinical practice setting.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriatic Arthritis
Intervention  ICMJE Drug: Etanercept
Administered according to the product monograph by subcutaneous (SC) injection
Other Name: Enbrel®
Study Arms  ICMJE Etanercept
Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
Intervention: Drug: Etanercept
Publications * Gladman DD, Bombardier C, Thorne C, Haraoui B, Khraishi M, Rahman P, Bensen W, Syrotuik J, Poulin-Costello M. Effectiveness and safety of etanercept in patients with psoriatic arthritis in a Canadian clinical practice setting: the REPArE trial. J Rheumatol. 2011 Jul;38(7):1355-62. doi: 10.3899/jrheum.100698. Epub 2011 May 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2007)
110
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Presence of psoriasis or previous evidence of psoriasis documented by a dermatologist as part of usual care
  • At least one of the following forms of psoriatic arthritis (PsA):

    • Distal interphalangeal (DIP) involvement (inflammatory)
    • Polyarticular arthritis, absence of rheumatoid nodules and presence of psoriasis
    • Arthritis mutilans
    • Asymmetric peripheral arthritis or
    • Spinal involvement
  • Active psoriatic arthritis at the time of the study enrollment
  • Patients must demonstrate greater than 3 swollen joints and greater than 3 tender/painful joints
  • Greater than 18 years of age at the time of consent
  • Able to start etanercept therapy per the approved product monograph
  • Informed consent must be provided before any study specific procedures are performed

Exclusion Criteria:

  • Active infections at time of initiating Enbrel® therapy
  • Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the study medication
  • A malignancy, other than basal cell carcinoma of the skin or, in situ carcinoma of the cervix, within the past 5 years
  • Known hypersensitivity to etanercept or any of its components
  • Patients receiving, or who have received:

    • Remicade® (infliximab) in the previous 3 months or -- Humira® (adalimumab) in the previous 3 months or
    • Kineret® (anakinra) in the previous 15 days
  • Patients receiving or who have received etanercept
  • Treatment with any investigational therapy in the 30 days prior to enrollment or during the study
  • Active guttate, erythrodermic or pustular psoriasis at the time of screening
  • Presence of any significant and uncontrolled medical condition, which in the Investigator's opinion, precludes the use of etanercept as outlined in the product monograph
  • Sepsis or at risk of septic syndrome
  • Patients not available for follow-up assessment
  • Concerns for subject's compliance with the protocol procedures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT00127842
Other Study ID Numbers  ICMJE 20040131
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP