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

Primary Purpose

Psoriasis, Psoriatic Arthritis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
lab draws and imaging
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Psoriasis focused on measuring non-therapeutic, interventional

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Modern Research Assoc. PLLC
  • Rheumatology Practive of Scott Zashin, MD
  • Center for Clinical Studies Ltd LLP
  • Rheumatology Associates of Houston
  • Center for Clinical Studies LTD LLP
  • Dermatology Associates
  • Algemeen Ziekenhuis St. Jan
  • Universitair Ziekenhuis Gent
  • Kirk Barber Research
  • Stratica Medical
  • Rheumatology Research Associates
  • The Skin Care Centre-Clinical Trials Unit
  • Winnipeg Clinic
  • Nexus Clinical Research
  • Dermatrials Research
  • MAC Research Ind.
  • K-W Musculoskeletal Research Inc.
  • Lynderm Research Inc
  • The Toronto Western Hospital-Division of Rheumatology
  • K.Papp Clinical Research Inc.
  • Windsor Clinical Research
  • Medical Office
  • Innovaderm Research Inc
  • Institut de Rheumatologie de Montreal
  • Diex Research Inc.
  • Clinique Medicale Belvedere
  • GRMO Inc.
  • Centre de Recherche Dermatologique du Quebec metropolitain
  • Hudlaegerne
  • Bispebjerg University Hospital
  • Gentofte Hospital
  • CHU de l Archet
  • Hopital Saint Louis
  • Hôpital Larrey
  • Klinik fuer Dermatologie, Allergologie und Venerologie
  • Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum
  • Klinikum der Johann Wolfgang Goethe Universitaet
  • Klinik und Poliklinik fuer Dermatologie und
  • Praxis Dres. Bredlich, Rosenbach und Thiele
  • Klinik und Poliklinik fuer Dermatologie
  • Synexus Magyarorszag Kft.
  • Debreceni Egyetem Orvos-és Egészségtudományi Centrum
  • Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz, Szent Ferenc Korhaz Telephely
  • Miskolci Semmelweis Ignac Egeszsegugyi Kozpont es Egyetemi Oktatokorhaz Nonprofit Kft/Borgyogyaszat
  • Borgyogyaszati es Allergologiai

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

psoriatic arthritis (PsA) questionnaire

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination, Medical History and Laboratory Results
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

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

Full Information

First Posted
June 17, 2010
Last Updated
May 18, 2012
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01147874
Brief Title
Prevalence of Psoriatic Arthritis in Adults With Psoriasis: An Estimate From Dermatology Practice
Acronym
PREPARE
Official Title
Prevalence of Psoriatic Arthritis in Adults With Psoriasis: An Estimate From Dermatology Practice
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Psoriatic Arthritis
Keywords
non-therapeutic, interventional

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1013 (Actual)

8. Arms, Groups, and Interventions

Arm Title
psoriatic arthritis (PsA) questionnaire
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
lab draws and imaging
Intervention Description
1 set of lab draws, imaging consists of radiographic imaging or X-ray, ultrasound and MRI
Primary Outcome Measure Information:
Title
Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination, Medical History and Laboratory Results
Description
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.
Time Frame
Week 0 through Week 8
Secondary Outcome Measure Information:
Title
Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination and Medical History
Description
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.
Time Frame
Week 0 through Week 8
Title
Percentage of Participants With Undiagnosed Psoriatic Arthritis (PsA)
Description
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.
Time Frame
Week 0 through Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Modern Research Assoc. PLLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75205
Country
United States
Facility Name
Rheumatology Practive of Scott Zashin, MD
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Center for Clinical Studies Ltd LLP
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Rheumatology Associates of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Center for Clinical Studies LTD LLP
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Dermatology Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Algemeen Ziekenhuis St. Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Kirk Barber Research
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2S 3B3
Country
Canada
Facility Name
Stratica Medical
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5K 1X3
Country
Canada
Facility Name
Rheumatology Research Associates
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5M 0H4
Country
Canada
Facility Name
The Skin Care Centre-Clinical Trials Unit
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
Facility Name
Winnipeg Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 0N2
Country
Canada
Facility Name
Nexus Clinical Research
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 5E8
Country
Canada
Facility Name
Dermatrials Research
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1V6
Country
Canada
Facility Name
MAC Research Ind.
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 2B6
Country
Canada
Facility Name
K-W Musculoskeletal Research Inc.
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2M 5N6
Country
Canada
Facility Name
Lynderm Research Inc
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1A8
Country
Canada
Facility Name
The Toronto Western Hospital-Division of Rheumatology
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
K.Papp Clinical Research Inc.
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Windsor Clinical Research
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada
Facility Name
Medical Office
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 4T2
Country
Canada
Facility Name
Innovaderm Research Inc
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada
Facility Name
Institut de Rheumatologie de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 1S6
Country
Canada
Facility Name
Diex Research Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
Clinique Medicale Belvedere
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1K 1K6
Country
Canada
Facility Name
GRMO Inc.
City
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Centre de Recherche Dermatologique du Quebec metropolitain
City
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Hudlaegerne
City
Arhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Bispebjerg University Hospital
City
Copenhagen NV
ZIP/Postal Code
DK-2400
Country
Denmark
Facility Name
Gentofte Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
CHU de l Archet
City
Nice Cedex 03
ZIP/Postal Code
06202
Country
France
Facility Name
Hopital Saint Louis
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Hôpital Larrey
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Klinik fuer Dermatologie, Allergologie und Venerologie
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe Universitaet
City
Frankfurt/Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Klinik und Poliklinik fuer Dermatologie und
City
Muenchen
ZIP/Postal Code
80802
Country
Germany
Facility Name
Praxis Dres. Bredlich, Rosenbach und Thiele
City
Osnabrueck
ZIP/Postal Code
49078
Country
Germany
Facility Name
Klinik und Poliklinik fuer Dermatologie
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
Facility Name
Synexus Magyarorszag Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Debreceni Egyetem Orvos-és Egészségtudományi Centrum
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz, Szent Ferenc Korhaz Telephely
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Miskolci Semmelweis Ignac Egeszsegugyi Kozpont es Egyetemi Oktatokorhaz Nonprofit Kft/Borgyogyaszat
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Borgyogyaszati es Allergologiai
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary

12. IPD Sharing Statement

Citations:
PubMed Identifier
23981683
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0881A6-4728&StudyName=Prevalence%20of%20Psoriatic%20Arthritis%20in%20Adults%20with%20Psoriasis%3A%20%20An%20Estimate%20from%20Dermatology%20Practice
Description
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Prevalence of Psoriatic Arthritis in Adults With Psoriasis: An Estimate From Dermatology Practice

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