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

May 18, 2012 updated by: Pfizer
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1013

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • Algemeen Ziekenhuis St. Jan
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
  • Canada
      • Quebec, Canada, G1V 4X7
        • Centre de Recherche Dermatologique du Quebec metropolitain
      • Quebec, Canada, G1V 3M7
        • GRMO Inc.
    • Alberta
      • Calgary, Alberta, Canada, T2S 3B3
        • Kirk Barber Research
      • Edmonton, Alberta, Canada, T5M 0H4
        • Rheumatology Research Associates
      • Edmonton, Alberta, Canada, T5K 1X3
        • Stratica Medical
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E8
        • The Skin Care Centre-Clinical Trials Unit
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 0N2
        • Winnipeg Clinic
    • Newfoundland and Labrador
      • Saint John's, Newfoundland and Labrador, Canada, A1A 5E8
        • Nexus Clinical Research
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1V6
        • Dermatrials Research
      • Hamilton, Ontario, Canada, L8N 2B6
        • MAC Research Ind.
      • Kitchener, Ontario, Canada, N2M 5N6
        • K-W Musculoskeletal Research Inc.
      • Markham, Ontario, Canada, L3P 1A8
        • Lynderm Research Inc
      • Toronto, Ontario, Canada, M5T 2S8
        • The Toronto Western Hospital-Division of Rheumatology
      • Waterloo, Ontario, Canada, N2J 1C4
        • K.Papp Clinical Research Inc.
      • Windsor, Ontario, Canada, N8W 5L7
        • Windsor Clinical Research
      • Windsor, Ontario, Canada, N8X 4T2
        • Medical Office
    • Quebec
      • Montreal, Quebec, Canada, H2K 4L5
        • Innovaderm Research Inc
      • Montreal, Quebec, Canada, H2L 1S6
        • Institut de Rheumatologie de Montreal
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • Diex Research Inc.
      • Sherbrooke, Quebec, Canada, J1K 1K6
        • Clinique Medicale Belvedere
  • Denmark
      • Arhus C, Denmark, 8000
        • Hudlaegerne
      • Copenhagen NV, Denmark, DK-2400
        • Bispebjerg University Hospital
      • Hellerup, Denmark, 2900
        • Gentofte Hospital
  • France
      • Nice Cedex 03, France, 06202
        • CHU de l Archet
      • Paris Cedex 10, France, 75475
        • Hopital Saint Louis
      • Toulouse, France, 31059
        • Hopital Larrey
  • Germany
      • Berlin, Germany, 10117
        • Klinik fuer Dermatologie, Allergologie und Venerologie
      • Erlangen, Germany, 91054
        • Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum
      • Frankfurt/Main, Germany, 60590
        • Klinikum der Johann Wolfgang Goethe Universitaet
      • Muenchen, Germany, 80802
        • Klinik und Poliklinik fuer Dermatologie und
      • Osnabrueck, Germany, 49078
        • Praxis Dres. Bredlich, Rosenbach und Thiele
      • Regensburg, Germany, 93042
        • Klinik und Poliklinik fuer Dermatologie
  • Hungary
      • Budapest, Hungary, 1036
        • Synexus Magyarorszag Kft.
      • Debrecen, Hungary, 4012
        • Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
      • Miskolc, Hungary, 3529
        • Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz, Szent Ferenc Korhaz Telephely
      • Miskolc, Hungary, 3529
        • Miskolci Semmelweis Ignac Egeszsegugyi Kozpont es Egyetemi Oktatokorhaz Nonprofit Kft/Borgyogyaszat
      • Szolnok, Hungary, 5000
        • Borgyogyaszati es Allergologiai
  • United States
    • Texas
      • Dallas, Texas, United States, 75205
        • Modern Research Assoc. PLLC
      • Dallas, Texas, United States, 75231
        • Rheumatology Practive of Scott Zashin, MD
      • Houston, Texas, United States, 77030
        • Center for Clinical Studies LTD LLP
      • Houston, Texas, United States, 77054
        • Rheumatology Associates of Houston
      • Webster, Texas, United States, 77598
        • Center for Clinical Studies LTD LLP
    • Washington
      • Seattle, Washington, United States, 98101
        • Dermatology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: psoriatic arthritis (PsA) questionnaire
Procedure: lab draws and imaging
1 set of lab draws, imaging consists of radiographic imaging or X-ray, ultrasound and MRI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Week 0 through Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Week 0 through Week 8
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.
Week 0 through Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0881A6-4728
  • B1801032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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