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

Amgen

Status and phase: Completed; Phase 4

Conditions: Psoriatic Arthritis

Treatments: Drug: Etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00127842

20040131

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Etanercept

Other group

Description:

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

Treatment:

Drug: Etanercept