Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Trial website
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

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00998829