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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01147874
First received: June 17, 2010
Last updated: May 18, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Psoriasis
Psoriatic Arthritis
Procedure: lab draws and imaging
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prevalence of Psoriatic Arthritis in Adults With Psoriasis: An Estimate From Dermatology Practice

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination, Medical History and Laboratory Results [ Time Frame: Week 0 through Week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 0 through Week 8 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 0 through Week 8 ] [ Designated as safety issue: No ]
    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.


Enrollment: 1013
Study Start Date: August 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • None.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01147874

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01147874     History of Changes
Other Study ID Numbers: 0881A6-4728, B1801032
Study First Received: June 17, 2010
Results First Received: May 18, 2012
Last Updated: May 18, 2012
Health Authority: European Union: European Medicines Agency
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 01, 2014