Clinical trial NCT00127842: REPArE: Rating Evaluations in Psoriatic Arthritis (PsA) With Etanercept (Enbrel®)
Official title: Rating Evaluations in Psoriatic Arthritis (PsA) With Enbrel®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis
PsA
Commercial product
American College of Rheumatology
ACR/PASI
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2005-08-09
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI
timeFrame: Baseline and 24 months
Secondary outcomes:
measure: Change From Baseline to Month 24 in the Health and Labour Questionnaire (HLQ) Absence From Work Module
timeFrame: Baseline and 24 months
measure: Change From Baseline to Month 24 in the HLQ Reduced Productivity at Paid Work Module
timeFrame: Baseline and Month 24
measure: Change From Baseline to Month 24 in the HLQ Unpaid Labour Production Module
timeFrame: Baseline and month 24
measure: Change From Baseline to Month 24 in the HLQ Impediments to Paid and Unpaid Labour Module
timeFrame: Baseline and month 24
measure: Change From Baseline to Month 24 in the Physician Global Assessment
timeFrame: Baseline and month 24
measure: Percent Change From Baseline to Month 24 in Physician Global Assessment
timeFrame: Baseline and Month 24
measure: Change From Baseline to Month 24 in Patient Global Assessment
timeFrame: Baseline and Month 24
measure: Percent Change From Baseline to Month 24 in Patient Global Assessment
timeFrame: Baseline and month 24
measure: Percentage of Participants With Improvement of ≥ 75 Percent From Baseline to Month 24 in the Psoriasis Activity and Severity Index (PASI)
timeFrame: Baseline and Month 24
measure: Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Month 24
timeFrame: Baseline and Month 24
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.