A Study in Participants With Psoriatic Arthritis Attending Dermatology Clinics

Psoriatic Arthritis Clinical Trial

— PARIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02470481
• Other study ID #: CR103908
• Secondary ID: CNTO148PSA4001
• Status: Completed
• Phase: Phase 4
• First received: June 10, 2015
• Last updated: September 1, 2016
• Start date: March 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Other:
• No Intervention
This is an obervational study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

Australia,  China,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Psoriatic Arthritis	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.	Baseline up to Day 28	No