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NCT00998829 Clinical Trial

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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00998829
Other study ID # 0881A6-4611
Secondary ID B1801063
Status Completed
Phase N/A
First received October 20, 2009
Last updated November 28, 2012
Start date May 2010
Est. completion date May 2012

Study information
Verified date November 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 458
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Australia Pfizer Investigational Site Bedford Park South Australia
Australia Pfizer Investigational Site Box Hill Victoria
Australia Pfizer Investigational Site Camperdown New South Wales
Australia Pfizer Investigational Site Carina Heights Queensland
Australia Pfizer Investigational Site Darlinghurst New South Wales
Australia Pfizer Investigational Site Fitzroy Victoria
Australia Pfizer Investigational Site Parkville Victoria
Australia Pfizer Investigational Site St Leonards New South Wales
Australia Pfizer Investigational Site Westmead New South Wales

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 14 days No
Primary 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 14 days No
Secondary Evaluate the proportion of patients within the enrolled patient population with moderate-to-severe plaque psoriasis (PASI [Psoriasis Area and Severity Index] > 10) 1 day No
Secondary Evaluate the proportion of patients in a tertiary population with moderate-to-severe psoriasis with respect to treatment history and current treatment 1 day No
Secondary Describe quality of life (QoL) in a tertiary psoriasis patient population 1 day No
Secondary 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 14 days No
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