Prevalence of Psoriatic Arthritis in Adults With Psoriasis: An Estimate From Dermatology Practice

Overview

This is a phase 4, multicenter, randomized, non-therapeutic interventional trial in subjects with psoriasis looking for the prevalence of psoriatic arthritis. Subjects will be seen and evaluated by a dermatologist at visit 1 and by a rheumatologist at visit 2. A subset of subjects will then go on to visit 3 for imaging procedures (x-ray, MRI, and ultrasound).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2011

Interventions

  • Procedure: lab draws and imaging
    • 1 set of lab draws, imaging consists of radiographic imaging or X-ray, ultrasound and MRI

Arms, Groups and Cohorts

  • No Intervention: psoriatic arthritis (PsA) questionnaire

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination, Medical History and Laboratory Results
    • Time Frame: Week 0 through Week 8
    • PsA: inflammatory arthritis associated with psoriasis that can have an indolent and progressive course. Percentage of participants with PsA was calculated by dividing the number of participants who were classified as positive by the rheumatologist and the total number of participants evaluated using medical history, physical examination and laboratory results as the basis for the diagnosis.

Secondary Measures

  • Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination and Medical History
    • Time Frame: Week 0 through Week 8
    • PsA: inflammatory arthritis associated with psoriasis that can have an indolent and progressive course. Percentage of participants with PsA was calculated by dividing the number of participants who were classified as positive by the rheumatologist and the total number of participants evaluated using medical history and physical examination as the basis for the diagnosis.
  • Percentage of Participants With Undiagnosed Psoriatic Arthritis (PsA)
    • Time Frame: Week 0 through Week 8
    • PsA: inflammatory arthritis associated with psoriasis that can have an indolent and progressive course. Primary PsA diagnosis made by rheumatologist based on physical examination, medical history and laboratory test results. Secondary PsA diagnosis made by rheumatologist based on physical examination and medical history only. For both, numerator was number of participants with “No” answer to question concerning previous diagnosis of PsA at Visit 1 (dermatology visit) and were subsequently classified as positive by rheumatologist; denominator was total number of participants evaluated for PsA.

Participating in This Clinical Trial

Inclusion Criteria

  • Subject is >18 years of age at the time of consent. – Subject has a confirmed diagnosis of plaque psoriasis by clinical judgment. – Subject is able to read and complete questionnaires. – Subjects planning to undergo radiographic evaluation, should not have any contraindications to MRI. Exclusion Criteria:

  • None.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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