Clinical trial NCT02470481: A Study in Participants With Psoriatic Arthritis Attending Dermatology Clinics
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriatic Arthritis
Keywords: Psoriatic arthritis
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2015-06-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with psoriatic arthritis among psoriasis participants attending dermatology clinics.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Psoriatic Arthritis
timeFrame: Baseline up to Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Fitzroy
country: Australia
city: New Lambton
country: Australia
city: Beijing
country: China
city: Hangzhou
country: China
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.