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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00998829




Registration number
NCT00998829
Ethics application status
Date submitted
20/10/2009
Date registered
21/10/2009
Date last updated
29/11/2012

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] 0 0
B1801063
Secondary ID [2] 0 0
0881A6-4611
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Psoriatic 0 0
Psoriasis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - questionnaire

Study population - The group comprises the entire study population


Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
14 days
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
14 days
Secondary outcome [1] 0 0
Evaluate the proportion of patients within the enrolled patient population with moderate-to-severe plaque psoriasis (PASI [Psoriasis Area and Severity Index] > 10)
Timepoint [1] 0 0
1 day
Secondary outcome [2] 0 0
Evaluate the proportion of patients in a tertiary population with moderate-to-severe psoriasis with respect to treatment history and current treatment
Timepoint [2] 0 0
1 day
Secondary outcome [3] 0 0
Describe quality of life (QoL) in a tertiary psoriasis patient population
Timepoint [3] 0 0
1 day
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
14 days

Eligibility
Key inclusion criteria
- Diagnosis of plaque psoriasis

- >= 18 years of age

- 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
- Participation in an interventional clinical trial in previous 3 months

- Known rheumatologist-confirmed psoriatic arthritis

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2012
Sample size
Target
Accrual to date
Final
458
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Camperdown
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Darlinghurst
Recruitment hospital [3] 0 0
Pfizer Investigational Site - St Leonards
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Westmead
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Carina Heights
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Bedford Park
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Box Hill
Recruitment hospital [8] 0 0
Pfizer Investigational Site - Fitzroy
Recruitment hospital [9] 0 0
Pfizer Investigational Site - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4152 - Carina Heights
Recruitment postcode(s) [6] 0 0
5042 - Bedford Park
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
3053 - Parkville

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00998829
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00998829