A Study in Participants With Psoriatic Arthritis Attending Dermatology Clinics

NCT ID: NCT02470481

Last Updated: 2016-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-07-31

Brief Summary

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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

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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).

Conditions

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Psoriatic Arthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

Participants with psoriatic arthritis among psoriasis particiants attending dermatology clinics.

No Intervention

Intervention Type OTHER

This is an obervational study

Interventions

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No Intervention

This is an obervational study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Fitzroy, , Australia

Site Status

New Lambton, , Australia

Site Status

Beijing, , China

Site Status

Hangzhou, , China

Site Status

Seoul, , South Korea

Site Status

Countries

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Australia China South Korea

References

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Jo SJ, Foley P, Oakley SP, Zhang J, Zheng M, Shin K, McGonagle D, Gisondi P, Tinazzi I, Butcher BE, Handel M. Initial assessment of the early arthritis for psoriatic patients diagnostic questionnaire in dermatology clinics in Australia, Korea and China. Int J Rheum Dis. 2019 Aug;22(8):1512-1520. doi: 10.1111/1756-185X.13604. Epub 2019 May 22.

Reference Type DERIVED
PMID: 31115158 (View on PubMed)

Other Identifiers

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CNTO148PSA4001

Identifier Type: OTHER

Identifier Source: secondary_id

CR103908

Identifier Type: -

Identifier Source: org_study_id

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