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

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ClinicalTrials.gov Identifier: NCT01147874
Recruitment Status : Completed
First Posted : June 22, 2010
Results First Posted : June 21, 2012
Last Update Posted : June 21, 2012
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Psoriasis Psoriatic Arthritis Procedure: lab draws and imaging Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1013 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prevalence of Psoriatic Arthritis in Adults With Psoriasis: An Estimate From Dermatology Practice
Study Start Date : August 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01147874


  Show 45 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01147874     History of Changes
Other Study ID Numbers: 0881A6-4728
B1801032
First Posted: June 22, 2010    Key Record Dates
Results First Posted: June 21, 2012
Last Update Posted: June 21, 2012
Last Verified: April 2012

Keywords provided by Pfizer:
non-therapeutic
interventional

Additional relevant MeSH terms:
Arthritis
Psoriasis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases