REPArE: Rating Evaluations in Psoriatic Arthritis (PsA) With Etanercept (Enbrel®)
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Etanercept
Intervention description: Administered according to the product monograph by subcutaneous (SC) injection
Intervention MeSH terms: Etanercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic Arthritis; PsA; Commercial product; American College of Rheumatology; ACR/PASI

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.
    

Eligibility 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