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

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ClinicalTrials.gov Identifier: NCT00998829
Recruitment Status : Completed
First Posted : October 21, 2009
Last Update Posted : November 29, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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 or disease Intervention/treatment
Arthritis, Psoriatic Psoriasis Other: questionnaire

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

Study Type : Observational
Actual Enrollment : 458 participants
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
Study Start Date : May 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Describe quality of life (QoL) in a tertiary psoriasis patient population [ Time Frame: 1 day ]
  4. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00998829     History of Changes
Other Study ID Numbers: 0881A6-4611
B1801063
First Posted: October 21, 2009    Key Record Dates
Last Update Posted: November 29, 2012
Last Verified: November 2012

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