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

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Etanercept

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