REPArE: Rating Evaluations in Psoriatic Arthritis (PsA) With Etanercept (Enbrel®)

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00127842
First received: August 5, 2005
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Psoriatic Arthritis
Drug: Etanercept
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rating Evaluations in Psoriatic Arthritis (PsA) With Enbrel®

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline to Month 24 in the Health and Labour Questionnaire (HLQ) Absence From Work Module [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Enrollment: 110
Study Start Date: August 2005
Study Completion Date: September 2009
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Etanercept
Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
Drug: Etanercept
Administered according to the product monograph by subcutaneous (SC) injection
Other Name: Enbrel®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127842

Sponsors and Collaborators
Amgen
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00127842     History of Changes
Other Study ID Numbers: 20040131
Study First Received: August 5, 2005
Results First Received: November 4, 2010
Last Updated: March 24, 2014
Health Authority: Canada: Health Canada
Canada: Institutional Review Board

Keywords provided by Amgen:
Psoriatic Arthritis
PsA
Commercial product
American College of Rheumatology
ACR/PASI

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 31, 2014