Clinical trial NCT01147874: Prevalence of Psoriatic Arthritis in Adults With Psoriasis: An Estimate From Dermatology Practice
Official title: Prevalence of Psoriatic Arthritis in Adults With Psoriasis: An Estimate From Dermatology Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Psoriatic Arthritis
Keywords: non-therapeutic
interventional
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 1013
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination, Medical History and Laboratory Results
timeFrame: Week 0 through Week 8
Secondary outcomes:
measure: Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination and Medical History
timeFrame: Week 0 through Week 8
measure: Percentage of Participants With Undiagnosed Psoriatic Arthritis (PsA)
timeFrame: Week 0 through Week 8
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Modern Research Assoc. PLLC
state: Texas
city: Dallas
country: United States
facility: Rheumatology Practive of Scott Zashin, MD
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies Ltd LLP
state: Texas
city: Houston
country: United States
facility: Rheumatology Associates of Houston
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies LTD LLP
state: Texas
city: Seattle
country: United States
facility: Dermatology Associates
state: Washington
city: Brugge
country: Belgium
facility: Algemeen Ziekenhuis St. Jan
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Calgary
country: Canada
facility: Kirk Barber Research
state: Alberta
city: Edmonton
country: Canada
facility: Stratica Medical
state: Alberta
city: Edmonton
country: Canada
facility: Rheumatology Research Associates
state: Alberta
city: Vancouver
country: Canada
facility: The Skin Care Centre-Clinical Trials Unit
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Clinic
state: Manitoba
city: Saint John's
country: Canada
facility: Nexus Clinical Research
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: Dermatrials Research
state: Ontario
city: Hamilton
country: Canada
facility: MAC Research Ind.
state: Ontario
city: Kitchener
country: Canada
facility: K-W Musculoskeletal Research Inc.
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: Toronto
country: Canada
facility: The Toronto Western Hospital-Division of Rheumatology
state: Ontario
city: Waterloo
country: Canada
facility: K.Papp Clinical Research Inc.
state: Ontario
city: Windsor
country: Canada
facility: Windsor Clinical Research
state: Ontario
city: Windsor
country: Canada
facility: Medical Office
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc
state: Quebec
city: Montreal
country: Canada
facility: Institut de Rheumatologie de Montreal
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Research Inc.
state: Quebec
city: Sherbrooke
country: Canada
facility: Clinique Medicale Belvedere
state: Quebec
city: Quebec
country: Canada
facility: GRMO Inc.
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec metropolitain
city: Arhus C
country: Denmark
facility: Hudlaegerne
city: Copenhagen NV
country: Denmark
facility: Bispebjerg University Hospital
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Nice Cedex 03
country: France
facility: CHU de l Archet
city: Paris Cedex 10
country: France
facility: Hopital Saint Louis
city: Toulouse
country: France
facility: Hôpital Larrey
city: Berlin
country: Germany
facility: Klinik fuer Dermatologie, Allergologie und Venerologie
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum
city: Frankfurt/Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe Universitaet
city: Muenchen
country: Germany
facility: Klinik und Poliklinik fuer Dermatologie und
city: Osnabrueck
country: Germany
facility: Praxis Dres. Bredlich, Rosenbach und Thiele
city: Regensburg
country: Germany
facility: Klinik und Poliklinik fuer Dermatologie
city: Budapest
country: Hungary
facility: Synexus Magyarorszag Kft.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos-és Egészségtudományi Centrum
city: Miskolc
country: Hungary
facility: Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz, Szent Ferenc Korhaz Telephely
city: Miskolc
country: Hungary
facility: Miskolci Semmelweis Ignac Egeszsegugyi Kozpont es Egyetemi Oktatokorhaz Nonprofit Kft/Borgyogyaszat
city: Szolnok
country: Hungary
facility: Borgyogyaszati es Allergologiai
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Mease PJ, Gladman DD, Papp KA, Khraishi MM, Thaci D, Behrens F, Northington R, Fuiman J, Bananis E, Boggs R, Alvarez D. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol. 2013 Nov;69(5):729-735. doi: 10.1016/j.jaad.2013.07.023. Epub 2013 Aug 24.