NCT00998829

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
458

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

November 29, 2012

Status Verified

November 1, 2012

Enrollment Period

2 years

First QC Date

October 20, 2009

Last Update Submit

November 28, 2012

Conditions

Arthritis, PsoriaticPsoriasis

Keywords

psoriasispsoriatic arthritisepidemiologyprevalence

Outcome Measures

Primary Outcomes (2)

  • 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

    14 days

  • 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

    14 days

Secondary Outcomes (4)

  • Evaluate the proportion of patients within the enrolled patient population with moderate-to-severe plaque psoriasis (PASI [Psoriasis Area and Severity Index] > 10)

    1 day

  • Evaluate the proportion of patients in a tertiary population with moderate-to-severe psoriasis with respect to treatment history and current treatment

    1 day

  • Describe quality of life (QoL) in a tertiary psoriasis patient population

    1 day

  • 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

    14 days

Study Arms (1)

Study population

The group comprises the entire study population

Other: questionnaire

Interventions

questionnaireOTHER

There is no therapeutic intervention in this study. However PASE (Psoriatic Arthritis Screening and Evaluation) and other patient questionnaires will be completed by participants.

Study population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Specialist dermatology clinics

You may qualify if:

  • Diagnosis of plaque psoriasis
  • \>= 18 years of age
  • Able to complete English-language questionnaires

You may not qualify if:

  • Participation in an interventional clinical trial in previous 3 months
  • Known rheumatologist-confirmed psoriatic arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Pfizer Investigational Site

Camperdown, New South Wales, 2050, Australia

Location

Pfizer Investigational Site

Darlinghurst, New South Wales, 2010, Australia

Location

Pfizer Investigational Site

St Leonards, New South Wales, 2065, Australia

Location

Pfizer Investigational Site

Westmead, New South Wales, 2145, Australia

Location

Pfizer Investigational Site

Carina Heights, Queensland, 4152, Australia

Location

Pfizer Investigational Site

Bedford Park, South Australia, 5042, Australia

Location

Pfizer Investigational Site

Box Hill, Victoria, 3128, Australia

Location

Pfizer Investigational Site

Fitzroy, Victoria, 3065, Australia

Location

Pfizer Investigational Site

Parkville, Victoria, 3053, Australia

Location

Related Links

MeSH Terms

Conditions

Arthritis, PsoriaticPsoriasis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2009

First Posted

October 21, 2009

Study Start

May 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

November 29, 2012

Record last verified: 2012-11

Locations

AU(9)