Clinical trial NCT00998829: Study Evaluating The Prevalence Of Undiagnosed Psoriatic Arthritis In Patients With Plaque Psoriasis
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Psoriatic
Psoriasis
Keywords: psoriasis
psoriatic arthritis
epidemiology
prevalence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-21
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Specialist dermatology clinics

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.

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

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 14 days
measure: 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
timeFrame: 14 days
Secondary outcomes:
measure: Evaluate the proportion of patients within the enrolled patient population with moderate-to-severe plaque psoriasis (PASI [Psoriasis Area and Severity Index] > 10)
timeFrame: 1 day
measure: Evaluate the proportion of patients in a tertiary population with moderate-to-severe psoriasis with respect to treatment history and current treatment
timeFrame: 1 day
measure: Describe quality of life (QoL) in a tertiary psoriasis patient population
timeFrame: 1 day
measure: 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
timeFrame: 14 days
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Darlinghurst
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: St Leonards
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Westmead
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Carina Heights
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Bedford Park
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Box Hill
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Fitzroy
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Parkville
country: Australia
facility: Pfizer Investigational Site
state: Victoria
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: