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Study Complete
Sponsor ID
20040131

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

Sponsor ID
20040131
Clinicaltrials.gov ID
NCT00127842
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 4
Product
etanercept
Type
Interventional
Masking
None (Open Label)
Enrollment
110
Additional Study Details

Protocol Summary

Primary Outcome Measures

Improvement of ≥ 0.50 Unit from Baseline to Month 24 in the HAQDI

Timeframe: Baseline and 24 months

Secondary Outcome Measures

Change from Baseline to Month 24 in the HLQ Absence from Work Module

Timeframe: Baseline and 24 months

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

Timeframe: Baseline and month 24

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

Timeframe: Baseline and month 24

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

Timeframe: Baseline and month 24

Change from Baseline to Month 24 in the Physician Global Assessment

Timeframe: Baseline and month 24

Percent Change from Baseline to Month 24 in Physician Global Assessment

Timeframe: Baseline and month 24

Change from Baseline to Month 24 in Patient Global Assessment

Timeframe: Baseline and month 24

Percent Change from Baseline to Month 24 in Patient Global Assessment

Timeframe: Baseline and month 24

Improvement of ≥ 75 Percent from Baseline to Month 24 in the PASI

Timeframe: Baseline and month 24

Psoriatic Arthritis Response Criteria Response at Month 24

Timeframe: Month 24

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Psoriatic Arthritis
    • Sex
    All
    Trial Dates
    Aug 2005 - Aug 2005
    Inclusion and Exclusion 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