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

NCT00127842 | Completed Phase 4 Results

• 1 other identifier: 20040131
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psoriatic Arthritis

Keywords

Psoriatic Arthritis; PsA; Commercial product; American College of Rheumatology; ACR/PASI

Outcome Measures

Primary Outcomes (1)

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

  The HAQ DI is a questionnaire which measures functional status in patients with psoriatic arthritis. The questionnaire addresses health-related quality of life issues related to psoriatic arthritis such as dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.

  Baseline and 24 months

Secondary Outcomes (10)

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

  Baseline and 24 months

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

  Baseline and Month 24

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

  Baseline and month 24

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

  Baseline and month 24

• Change From Baseline to Month 24 in the Physician Global Assessment

  Baseline and month 24

Study Arms (1)

Etanercept

OTHER

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

Drug: Etanercept

Interventions

Etanercept DRUG

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

Also known as: Enbrel®

Etanercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Related Publications (1)

• 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.

  PMID: 21572156 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2005
• First Posted: August 9, 2005
• Study Start: August 1, 2005
• Primary Completion: August 1, 2005
• Study Completion: September 1, 2009
• Last Updated: April 24, 2014
• Results First Posted: April 24, 2014

Record last verified: 2014-03