A Study in Participants With Psoriatic Arthritis Attending Dermatology Clinics

Completed

• Conditions: Psoriatic Arthritis
• Interventions: Other: No Intervention

• Registration Number: NCT02470481
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

The purpose of this study is to conduct full psychometric testing of the Early Arthritis for Psoriatic Patients (EARP) questionnaire in Australian, Korean and Chinese populations

Detailed Description

This is a multicentre, observational, descriptive estimate of the proportion of participants with psoriatic arthritis among psoriasis participants attending dermatology clinics selected for this study. In addition, this study will involve full psychometric assessment of the Early psoriatic screening questionnaire (EARP) questionnaire with the aim of identifying and appropriately referring participants to a rheumatologist for review if their EARP score is 3 or greater at Screening (i.e. \>= 3 at Visit 1).

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-06-10
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-12
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-01
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Patient must be a man or woman aged 18 to 65 years of age, inclusive
• The patient must have an established diagnosis of psoriasis (based upon clinical evidence, and documented medical history [19])
• The patient must be able to read and write in the target language (English, Mandarin or Korean; or other relevant target languages)
• Each patient must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study

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Exclusion Criteria

• An established diagnosis of psoriatic arthritis
• Ever have received systemic treatment with a disease modifying antirheumatic drug (DMARD) for arthritis or spondylitis (inflammatory back pain)
• Ever have received systemic treatment with a biologic therapy for psoriasis (including infliximab, golimumab, ustekinumab, adalimumab or etanercept)
• A history of employment in or are currently employed in the healthcare industry; or
• Participated in the translation and linguistic validation of the EARP questionnaire

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	No Intervention	Participants with psoriatic arthritis among psoriasis particiants attending dermatology clinics.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Psoriatic Arthritis	Baseline up to Day 28	Percentage of participants with psoriatic arthritis will be assessed using formula: Number of participants diagnosed with psoriatic arthritis divided by total number of participants with psoriasis attending the dermatology clinic.