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

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00127842
First received: August 5, 2005
Last updated: November 12, 2009
Last verified: November 2009
  Purpose

The primary objective of the study is to estimate the proportion of psoriatic arthritis (PsA) subjects achieving a greater than 0.50 unit improvement from baseline in the Healthcare Quality Assurance (HQA) disability index at month 24. Given a sample size of 125 subjects, the precision of the estimate, as reflected by the width of the 95% confidence interval, will not exceed 0.176 units.


Condition Intervention Phase
Psoriatic Arthritis
Drug: Enbrel®
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rating Evaluations in Psoriatic Arthritis (PsA) With Enbrel®

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Describe long term effectiveness of Enbrel® in subjects with PsA as measured by the Health Assessment Questionnaire Disability Index (HAQDI) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Describe long term productivity of Enbrel® in subjects with PsA in Canadian clinical practice [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: August 2005
Study Completion Date: September 2009
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Enbrel
Single Arm study, all patients on Enbrel
Drug: Enbrel®
Single Arm, all patients on Enbrel

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 PsA:

  1. Distal interphalangeal (DIP) involvement (inflammatory)
  2. Polyarticular arthritis, absence of rheumatoid nodules and presence of psoriasis
  3. Arthritis mutilans
  4. Asymmetric peripheral arthritis or
  5. Spinal involvement - Active psoriatic arthritis at the time of the study enrollment - Subjects 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 Enbrel® 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 Enbrel® or any of its components - Subjects 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 - Subjects receiving or who have received Enbrel® - 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 Enbrel® as outlined in the product monograph - Sepsis or at risk of septic syndrome - Subjects not available for follow-up assessment - Concerns for subject's compliance with the protocol procedures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127842

Locations
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada
Research Site
Victoria, British Columbia, Canada
Canada, Manitoba
Research Site
Winnipeg, Manitoba, Canada
Canada, New Brunswick
Research Site
Fredericton, New Brunswick, Canada
Canada, Newfoundland and Labrador
Research Site
St. John's, Newfoundland and Labrador, Canada
Canada, Ontario
Research Site
Brampton, Ontario, Canada
Research Site
Burlington, Ontario, Canada
Research Site
Concord, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Kitchener, Ontario, Canada
Research Site
Nepean, Ontario, Canada
Research Site
Newmarket, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Windsor, Ontario, Canada
Canada, Quebec
Research Site
Laval, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Sherbrooke, Quebec, Canada
Research Site
Trois-Rivieres, Quebec, Canada
Canada, Saskatchewan
Research Site
Saskatoon, Saskatchewan, Canada
Sponsors and Collaborators
Amgen
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00127842     History of Changes
Other Study ID Numbers: 20040131
Study First Received: August 5, 2005
Last Updated: November 12, 2009
Health Authority: Canada: Health Canada
Canada: Institutional Review Board

Keywords provided by Amgen:
Psoriatic Arthritis
PsA
Commercial product
American College of Rheumatology
ACR/PASI

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014