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Completed

NCT Number: NCT02470481

A Study in Participants With Psoriatic Arthritis Attending Dermatology Clinics

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fitzroy, Australia

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

No intervention

Other

This is an obervational study

Primary outcomes

  1. Percentage of Participants With Psoriatic Arthritis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

Psoriatic Arthritis In Skin Clinics (PARIS) Study. A Multicentre, Observational, Descriptive Cross-Cultural Validation Study and Estimate of the Proportion of Patients With Psoriatic Arthritis Among Psoriasis Patients Attending Dermatology Clinics Selected for This Study

Acronym: PARIS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 12, 2015
Registry last updated
Sep 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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