Status:
COMPLETED
REPArE: Rating Evaluations in Psoriatic Arthritis (PsA) With Etanercept (Enbrel®)
Lead Sponsor:
Amgen
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Psoriatic Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00127842
Start Date
August 1 2005
End Date
September 1 2009
Last Update
April 24 2014
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