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Trial record 1 of 1 for:    NCT00998829
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Study Evaluating The Prevalence Of Undiagnosed Psoriatic Arthritis In Patients With Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT00998829
Recruitment Status : Completed
First Posted : October 21, 2009
Last Update Posted : November 29, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date October 20, 2009
First Posted Date October 21, 2009
Last Update Posted Date November 29, 2012
Study Start Date May 2010
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 31, 2010)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures
 (submitted: October 20, 2009)
Prevalence of undiagnosed psoriatic arthritis in patients presenting with plaque psoriasis [ Time Frame: 14 days ]
Change History Complete list of historical versions of study NCT00998829 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 31, 2010)
  • 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 ]
  • 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 ]
  • Describe quality of life (QoL) in a tertiary psoriasis patient population [ Time Frame: 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 [ Time Frame: 14 days ]
Original Secondary Outcome Measures
 (submitted: October 20, 2009)
Evaluate the relationship between PASE score and rheumatologist-confirmed diagnosis of PsA [ Time Frame: 14 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study Evaluating The Prevalence Of Undiagnosed Psoriatic Arthritis In Patients With Plaque Psoriasis
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
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.
Detailed Description Consecutive psoriasis patients seen at each site will be invited to participate in the study
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Specialist dermatology clinics
Condition
  • Arthritis, Psoriatic
  • Psoriasis
Intervention 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.
Study Groups/Cohorts Study population
The group comprises the entire study population
Intervention: Other: questionnaire
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 28, 2012)
458
Original Estimated Enrollment
 (submitted: October 20, 2009)
500
Actual Study Completion Date May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia
Removed Location Countries  
 
Administrative Information
NCT Number NCT00998829
Other Study ID Numbers 0881A6-4611
B1801063
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2012