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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02470481




Registration number
NCT02470481
Ethics application status
Date submitted
10/06/2015
Date registered
12/06/2015
Date last updated
2/09/2016

Titles & IDs
Public title
A Study in Participants With Psoriatic Arthritis Attending Dermatology Clinics
Scientific 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
Secondary ID [1] 0 0
CNTO148PSA4001
Secondary ID [2] 0 0
CR103908
Universal Trial Number (UTN)
Trial acronym
PARIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No Intervention

Cohort 1 - Participants with psoriatic arthritis among psoriasis particiants attending dermatology clinics.


Other interventions: No Intervention
This is an obervational study
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Psoriatic Arthritis
Timepoint [1] 0 0
Baseline up to Day 28

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2016
Sample size
Target
Accrual to date
Final
250
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Fitzroy
Recruitment hospital [2] 0 0
- New Lambton
Recruitment postcode(s) [1] 0 0
- Fitzroy
Recruitment postcode(s) [2] 0 0
- New Lambton
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Hangzhou
Country [3] 0 0
Korea, Republic of
State/province [3] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT02470481
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02470481