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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Psoriatic Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Etanercept

Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.

Group Type OTHER

Etanercept

Intervention Type DRUG

Administered according to the product monograph by subcutaneous (SC) injection

Interventions

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Etanercept

Administered according to the product monograph by subcutaneous (SC) injection

Intervention Type DRUG

Other Intervention Names

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Enbrel®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No