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

Information source: Amgen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriatic Arthritis

Intervention: Etanercept (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

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.

Clinical Details

Official title: Rating Evaluations in Psoriatic Arthritis (PsA) With Enbrel

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI

Secondary outcome:

Change From Baseline to Month 24 in the Health and Labour Questionnaire (HLQ) Absence From Work Module

Change From Baseline to Month 24 in the HLQ Reduced Productivity at Paid Work Module

Change From Baseline to Month 24 in the HLQ Unpaid Labour Production Module

Change From Baseline to Month 24 in the HLQ Impediments to Paid and Unpaid Labour Module

Change From Baseline to Month 24 in the Physician Global Assessment

Percent Change From Baseline to Month 24 in Physician Global Assessment

Change From Baseline to Month 24 in Patient Global Assessment

Percent Change From Baseline to Month 24 in Patient Global Assessment

Percentage of Participants With Improvement of ≥ 75 Percent From Baseline to Month 24 in the Psoriasis Activity and Severity Index (PASI)

Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Month 24

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

AmgenTrials clinical trials website

Related publications:

Gladman DD, Bombardier C, Thorne C, Haraoui B, Khraishi M, Rahman P, Bensen W, Syrotuik J, Poulin-Costello M. Effectiveness and safety of etanercept in patients with psoriatic arthritis in a Canadian clinical practice setting: the REPArE trial. J Rheumatol. 2011 Jul;38(7):1355-62. doi: 10.3899/jrheum.100698. Epub 2011 May 15.

Starting date: August 2005
Last updated: March 24, 2014

Page last updated: August 20, 2015

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