Study Evaluating The Prevalence Of Undiagnosed Psoriatic Arthritis In Patients With Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00998829
First received: October 20, 2009
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

This study aims to collect Australian data on the prevalence of undiagnosed psoriatic arthritis in patients with plaque psoriasis. In addition the study will assess disease severity and quality of life in Australian patients with psoriasis attending specialist dermatology clinics.


Condition Intervention
Arthritis, Psoriatic
Psoriasis
Other: questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: An Australian Cross-Sectional Epidemiological Study To Evaluate The Prevalence Of Undiagnosed Psoriatic Arthritis In Psoriasis Patients In Dermatology Practice Focusing On Disease Severity, Disease Burden And Quality Of Life

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To evaluate the prevalence of undiagnosed psoriatic arthritis in patients presenting with plaque psoriasis using the PASE (Psoriatic Arthritis Screening and Evaluation) questionnaire based on a score of ≥ 44 on the questionnaire [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Evaluate the positive predictive value between PASE (Psoriatic Arthritis Screening and Evaluation) score ≥ 44 and rheumatologist-confirmed diagnosis of psoriatic arthritis in a population of tertiary Australian psoriasis patients [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the proportion of patients within the enrolled patient population with moderate-to-severe plaque psoriasis (PASI [Psoriasis Area and Severity Index] > 10) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Evaluate the proportion of patients in a tertiary population with moderate-to-severe psoriasis with respect to treatment history and current treatment [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Describe quality of life (QoL) in a tertiary psoriasis patient population [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Explore the relationship between disease severity and QoL (quality of life) and stratified by the presence or absence of psoriatic arthritis in a tertiary population [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 458
Study Start Date: May 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Study population
The group comprises the entire study population
Other: questionnaire
There is no therapeutic intervention in this study. However PASE (Psoriatic Arthritis Screening and Evaluation) and other patient questionnaires will be completed by participants.

Detailed Description:

Consecutive psoriasis patients seen at each site will be invited to participate in the study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Specialist dermatology clinics

Criteria

Inclusion Criteria:

  • Diagnosis of plaque psoriasis
  • >= 18 years of age
  • Able to complete English-language questionnaires

Exclusion Criteria:

  • Participation in an interventional clinical trial in previous 3 months
  • Known rheumatologist-confirmed psoriatic arthritis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998829

Locations
Australia, New South Wales
Pfizer Investigational Site
Camperdown, New South Wales, Australia, 2050
Pfizer Investigational Site
Darlinghurst, New South Wales, Australia, 2010
Pfizer Investigational Site
St Leonards, New South Wales, Australia, 2065
Pfizer Investigational Site
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Pfizer Investigational Site
Carina Heights, Queensland, Australia, 4152
Australia, South Australia
Pfizer Investigational Site
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Pfizer Investigational Site
Box Hill, Victoria, Australia, 3128
Pfizer Investigational Site
Fitzroy, Victoria, Australia, 3065
Pfizer Investigational Site
Parkville, Victoria, Australia, 3053
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00998829     History of Changes
Other Study ID Numbers: 0881A6-4611, B1801063
Study First Received: October 20, 2009
Last Updated: November 28, 2012
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Pfizer:
psoriasis
psoriatic arthritis
epidemiology
prevalence

Additional relevant MeSH terms:
Arthritis
Psoriasis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases

ClinicalTrials.gov processed this record on September 30, 2014