Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000272099
Ethics application status
Approved
Date submitted
30/03/2010
Date registered
1/04/2010
Date last updated
11/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Study Evaluating the Prevalence of Undiagnosed Psoriatic Arthritis in Patients With Plaque Psoriasis
Scientific 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
Secondary ID [1] 1552 0
ClinicalTrials.gov NCT00998829
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plaque psoriasis 257046 0
Psoriatic arthritis 257047 0
Condition category
Condition code
Skin 257208 257208 0 0
Dermatological conditions
Musculoskeletal 257209 257209 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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. The study will recruit patients over a 6 month period.
Intervention code [1] 256222 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258100 0
Prevalence of undiagnosed psoriatic arthritis in patients presenting with plaque psoriasis
Timepoint [1] 258100 0
This will be measured at the end of the study.
Secondary outcome [1] 263702 0
Evaluate the relationship between the Psoriatic Arthritis Screening and Evaluation (PASE) score and rheumatologist-confirmed diagnosis of psoriatic arthritis (PsA)
Timepoint [1] 263702 0
This will be measured at the end of the study.

Eligibility
Key inclusion criteria
1. Diagnosis of plaque psoriasis
2. >= 18 years of age
3. Able to complete English-language questionnaires
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participation in an interventional clinical trial in previous 3 months
2. Known rheumatologist-confirmed psoriatic arthritis

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2667 0
3065
Recruitment postcode(s) [2] 2668 0
2170
Recruitment postcode(s) [3] 2669 0
2065
Recruitment postcode(s) [4] 2670 0
2050
Recruitment postcode(s) [5] 2671 0
5042
Recruitment postcode(s) [6] 2672 0
4102
Recruitment postcode(s) [7] 2673 0
3128
Recruitment postcode(s) [8] 2674 0
Remove
Recruitment postcode(s) [9] 2675 0
2010

Funding & Sponsors
Funding source category [1] 256723 0
Commercial sector/Industry
Name [1] 256723 0
Wyeth Australia Pty Limited
Country [1] 256723 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Wyeth Australia Pty Limited
Address
38-42 Wharf Road
West Ryde NSW 2114
Country
Australia
Secondary sponsor category [1] 256007 0
None
Name [1] 256007 0
Address [1] 256007 0
Country [1] 256007 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The purpose of this study is to evaluate how common psoriatic arthritis is in patients with plaque psoriasis. The study will also explore whether psoriasis severity affects a patient's daily activities and quality of life. This information is important to assess if there is unmet medical need in Australian patients with psoriasis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30990 0
Address 30990 0
Country 30990 0
Phone 30990 0
Fax 30990 0
Email 30990 0
Contact person for public queries
Name 14237 0
Trial Manager
Address 14237 0
Wyeth Australia
38-42 Wharf Road
West Ryde NSW 2114
Country 14237 0
Australia
Phone 14237 0
+61288508200
Fax 14237 0
Email 14237 0
tremetsATwyeth.com (this email address is spelt out to deflect spam mail robots - please replace "AT" with "@" when typing the address)
Contact person for scientific queries
Name 5165 0
Medical Monitor
Address 5165 0
Wyeth Australia
38-42 Wharf Road
West Ryde NSW 2114
Country 5165 0
Australia
Phone 5165 0
+61298503333
Fax 5165 0
Email 5165 0
thiruk2ATwyeth.com (this email address is spelt out to deflect spam mail robots - please replace "AT" with "@" when typing the address)

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.