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

Phase 4

Completed

Conditions: Psoriasis
Psoriatic Arthritis

Interventions: Procedure: lab draws and imaging

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

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

Arm && Interventions

Group	Intervention	Description
psoriatic arthritis (PsA) questionnaire	lab draws and imaging	-

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): MAC Research Ind.
🇨🇦
Hamilton, Ontario, Canada
Lynderm Research Inc
🇨🇦
Markham, Ontario, Canada
The Toronto Western Hospital-Division of Rheumatology
🇨🇦
Toronto, Ontario, Canada
Hudlaegerne
🇩🇰
Arhus C, Denmark
Klinik und Poliklinik fuer Dermatologie
🇩🇪
Regensburg, Germany
Kirk Barber Research
🇨🇦
Calgary, Alberta, Canada
Clinique Medicale Belvedere
🇨🇦
Sherbrooke, Quebec, Canada
Stratica Medical
🇨🇦
Edmonton, Alberta, Canada
Rheumatology Research Associates
🇨🇦
Edmonton, Alberta, Canada
Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz, Szent Ferenc Korhaz Telephely
🇭🇺
Miskolc, Hungary
The Skin Care Centre-Clinical Trials Unit
🇨🇦
Vancouver, British Columbia, Canada
Innovaderm Research Inc
🇨🇦
Montreal, Quebec, Canada
Institut de Rheumatologie de Montreal
🇨🇦
Montreal, Quebec, Canada
Diex Research Inc.
🇨🇦
Sherbrooke, Quebec, Canada
Synexus Magyarorszag Kft.
🇭🇺
Budapest, Hungary
Debreceni Egyetem Orvos-és Egészségtudományi Centrum
🇭🇺
Debrecen, Hungary
Miskolci Semmelweis Ignac Egeszsegugyi Kozpont es Egyetemi Oktatokorhaz Nonprofit Kft/Borgyogyaszat
🇭🇺
Miskolc, Hungary
Borgyogyaszati es Allergologiai
🇭🇺
Szolnok, Hungary
Rheumatology Practive of Scott Zashin, MD
🇺🇸
Dallas, Texas, United States
Rheumatology Associates of Houston
🇺🇸
Houston, Texas, United States
Algemeen Ziekenhuis St. Jan
🇧🇪
Brugge, Belgium
Winnipeg Clinic
🇨🇦
Winnipeg, Manitoba, Canada
Modern Research Assoc. PLLC
🇺🇸
Dallas, Texas, United States
Center for Clinical Studies Ltd LLP
🇺🇸
Houston, Texas, United States
Center for Clinical Studies LTD LLP
🇺🇸
Webster, Texas, United States
Dermatology Associates
🇺🇸
Seattle, Washington, United States
Universitair Ziekenhuis Gent
🇧🇪
Gent, Belgium
Nexus Clinical Research
🇨🇦
Saint John's, Newfoundland and Labrador, Canada
Dermatrials Research
🇨🇦
Hamilton, Ontario, Canada
K-W Musculoskeletal Research Inc.
🇨🇦
Kitchener, Ontario, Canada
K.Papp Clinical Research Inc.
🇨🇦
Waterloo, Ontario, Canada
Medical Office
🇨🇦
Windsor, Ontario, Canada
Windsor Clinical Research
🇨🇦
Windsor, Ontario, Canada
GRMO Inc.
🇨🇦
Quebec, Canada
Bispebjerg University Hospital
🇩🇰
Copenhagen NV, Denmark
Centre de Recherche Dermatologique du Quebec metropolitain
🇨🇦
Quebec, Canada
Gentofte Hospital
🇩🇰
Hellerup, Denmark
CHU de l Archet
🇫🇷
Nice Cedex 03, France
Hopital Saint Louis
🇫🇷
Paris Cedex 10, France
Klinik fuer Dermatologie, Allergologie und Venerologie
🇩🇪
Berlin, Germany
Hôpital Larrey
🇫🇷
Toulouse, France
Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum
🇩🇪
Erlangen, Germany
Klinik und Poliklinik fuer Dermatologie und
🇩🇪
Muenchen, Germany
Klinikum der Johann Wolfgang Goethe Universitaet
🇩🇪
Frankfurt/Main, Germany
Praxis Dres. Bredlich, Rosenbach und Thiele
🇩🇪
Osnabrueck, Germany