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

Phase 4

Completed

• Conditions: Psoriasis; Psoriatic Arthritis

• Registration Number: NCT01147874
• Lead Sponsor: Pfizer

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-17
• Study First Submitted QC: 2010-06-17
• Study First Posted: 2010-06-22
• Study Start: 2010-08
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-04
• Results First Submitted: 2012-05-18
• Results First Submitted QC: 2012-05-18
• Last Update Submitted: 2012-05-18
• Results First Posted: 2012-06-21
• Last Update Posted: 2012-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1013

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination, Medical History and Laboratory Results	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 Outcome Measures

Name	Time	Method
Percentage of Participants With Undiagnosed Psoriatic Arthritis (PsA)	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.
Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination and Medical History	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.

Trial Locations

Locations (45)

Modern Research Assoc. PLLC; 🇺🇸 Dallas, Texas, United States

Rheumatology Practive of Scott Zashin, MD; 🇺🇸 Dallas, Texas, United States

Center for Clinical Studies Ltd LLP; 🇺🇸 Houston, Texas, United States

Rheumatology Associates of Houston; 🇺🇸 Houston, Texas, United States

Center for Clinical Studies LTD LLP; 🇺🇸 Webster, Texas, United States

Dermatology Associates; 🇺🇸 Seattle, Washington, United States

Algemeen Ziekenhuis St. Jan; 🇧🇪 Brugge, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

Kirk Barber Research; 🇨🇦 Calgary, Alberta, Canada

Stratica Medical; 🇨🇦 Edmonton, Alberta, Canada

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