Psoriatic ArthritisPARISNCT02470481
A Study in Participants With Psoriatic Arthritis Attending Dermatology Clinics
An observational study of Psoriatic Arthritis, run by Janssen Research & Development, LLC at 5 sites in 3 countries.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriatic Arthritis
- How many people
- 250 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Mar 2015to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with psoriatic arthritis among psoriasis participants attending dermatology clinics.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
About this study
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
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
Read the 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).
- Conditions
- Psoriatic Arthritis
- Being tested
- No Intervention
- Keywords
- Psoriatic arthritis
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is an obervational study
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants with psoriatic arthritis among psoriasis particiants attending dermatology clinics. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470481
- Sponsor's protocol ID
- CR103908
- Other IDs
- CNTO148PSA4001
- Acronym
- PARIS
- Status last verified
- Sep 2016
- First submitted
- 10 Jun 2015
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31115158
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02470481
- Acronym / sponsor ID
- PARIS / CR103908
- Conditions
- Psoriatic Arthritis
- Keywords
- Psoriatic arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: No InterventionParticipants with psoriatic arthritis among psoriasis particiants attending dermatology clinics. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with psoriatic arthritis among psoriasis participants attending dermatology clinics.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is an obervational study | Other | Cohort 1 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
- Derived from this study: PubMed 31115158Jo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis, run by Janssen Research & Development, LLC at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, China, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Psoriatic Arthritis (time frame: Baseline up to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02470481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.