Study Evaluating The Prevalence Of Undiagnosed Psoriatic Arthritis In Patients With Plaque Psoriasis
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00998829
First received: October 20, 2009
Last updated: November 28, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Arthritis, Psoriatic Psoriasis |
Other: questionnaire |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
psoriatic arthritis
MedlinePlus related topics:
Psoriasis
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evaluate the proportion of patients within the enrolled patient population with moderate-to-severe plaque psoriasis (PASI [Psoriasis Area and Severity Index] > 10) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Evaluate the proportion of patients in a tertiary population with moderate-to-severe psoriasis with respect to treatment history and current treatment [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Describe quality of life (QoL) in a tertiary psoriasis patient population [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
| Enrollment: | 458 |
| Study Start Date: | May 2010 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Study population
The group comprises the entire study population
|
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.
|
Detailed Description:
Consecutive psoriasis patients seen at each site will be invited to participate in the study
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Specialist dermatology clinics
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998829
Locations
| Australia, New South Wales | |
| Pfizer Investigational Site | |
| Camperdown, New South Wales, Australia, 2050 | |
| Pfizer Investigational Site | |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Pfizer Investigational Site | |
| St Leonards, New South Wales, Australia, 2065 | |
| Pfizer Investigational Site | |
| Westmead, New South Wales, Australia, 2145 | |
| Australia, Queensland | |
| Pfizer Investigational Site | |
| Carina Heights, Queensland, Australia, 4152 | |
| Australia, South Australia | |
| Pfizer Investigational Site | |
| Bedford Park, South Australia, Australia, 5042 | |
| Australia, Victoria | |
| Pfizer Investigational Site | |
| Box Hill, Victoria, Australia, 3128 | |
| Pfizer Investigational Site | |
| Fitzroy, Victoria, Australia, 3065 | |
| Pfizer Investigational Site | |
| Parkville, Victoria, Australia, 3053 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00998829 History of Changes |
| Other Study ID Numbers: | 0881A6-4611, B1801063 |
| Study First Received: | October 20, 2009 |
| Last Updated: | November 28, 2012 |
| Health Authority: | Australia: Human Research Ethics Committee |
Keywords provided by Pfizer:
|
psoriasis psoriatic arthritis epidemiology prevalence |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Psoriatic Psoriasis Joint Diseases Musculoskeletal Diseases Spondylarthropathies |
Spondylarthritis Spondylitis Spinal Diseases Bone Diseases Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on June 18, 2013