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PsoriasisTUPASTNCT04277832

Evaluating of New Screening Tool for Arthritis* in Psoriasis

An observational study of Psoriasis and Psoriatic Arthritis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates a new screening tool for arthritis in psoriasis and compares its reliability with well-known screening tool (TOPAS 2). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Psoriasis, Psoriatic Arthritis
What is being tested?
Questionary
How many people
200 participants
Where
1 siteTurkey (Türkiye)
Study dates
21 Feb 2020to 13 Jan 2021
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients over 18 years with psoriasis

Who may be able to join

  • Psoriasis confirmed by dermatologist

Who cannot join

  • Unable to consent and understand
  • Known other rheumatological disease

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Bezmialem Vakıf Univesity

    Istanbul, 34093

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of a New Screening Tool (TUPAST) for Psoriatic Arthritis in Turkish Psoriasis Population and Comparison With TOPAS 2 for Validation of TUPAST

This study evaluates a new screening tool for arthritis in psoriasis and compares its reliability with well-known screening tool (TOPAS 2).

Read the detailed description

Early diagnosis and treatment of PsA may prevent destruction in joints.Our aim is to create a simple and user friendly screening tool that can be used by dermatologists in out patient clinics.

A question pool will be created from a review of the literature and expert opinions from a physicians experienced in rheumatology and dermatologists .Psoriasis patients will answer these newly created questions. All patients will be examined by dermatology and also physical therapy and rehabilitation-rheumatology experts. The diagnosis of psoriatic arthritis (PsA) will be made by CASPAR (Classification criteria for psoriatic arthritis) criteria and ASAS (Assessment of Spondyloarthritis International Society) criteria for spondyloarthritis. Synchronously patients will be asked for to reply Turkish version of well known questionary named TOPAS 2. According to the results of collected data, statistically best matched questions will be selected for Turkish population. Also, the reliability of TUPAST (Turkish PsA Screening Tool) and TOPAS 2 (Toronto Psoriatic Arthritis Screen II) will be compared statistically.

Being tested
Questionary
Keywords
psoriasis, psoriatic arthritis, screening tool
Medical subject headings
Psoriasis, Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionaryDiagnostic test

    All patients will answer two different questionary (TUPAST, TOPAS 2)

Study groups in NCT04277832
Study groupRoleWhat they receive
single armGroup of psoriasis patients will select randomly. All selected psoriasis patients will be consulted to a physician experienced in rheumatology and all of patients will fill TUPAST and TOPAS 2 forms.
Receives: Diagnostic Test: Questionary

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Creation of new tool (TUPAST: Turkish psoriatic arthritis screening tool) for detecting psoriatic arthritis among psoriasis patients

    Questions which related with psoriatic arthritis will be selected statistically. Factor analysis will be performed to select the questions to construct the questionnaire. ROC (receiver operating characteristic) will be used to pick the best cut point for tool. Then, sensitivity and specificity of new tool to detect psoriatic arthritis among psoriasis patients will be calculated.

    Measured: six months, throughout the study

  2. Correlation between TOPAS 2 score and probability of psoriatic arthritis in psoriasis patients

    TOPAS 2 (Toronto Psoriatic Arthritis Screen II ) is a questionnaire for detecting psoriatic arthritis which has 95.8% sensitivity and 98% specificity in Turkish population. All patients will answer TOPAS 2 questions and all patients will be examined by dermatology and also physical therapy and rehabilitation-rheumatology experts.The diagnosis of psoriatic arthritis (PsA) will be made by CASPAR (Classification criteria for psoriatic arthritis) criteria and ASAS (Assessment of Spondyloarthritis International Society) criteria for spondyloarthritis.Then, sensitivity and specificity of TOPAS 2 will be calculated in our group and the correlation between psoriatic arthritis and screening tool results will be seen.

    Measured: six months, throughout the study

  3. Comparison of the reliability of the TUPAST and TOPAS 2

    All patients will answer TUPAST and TOPAS 2 at the same time. According to statistical results, reliability of this two tool will be compared.

    Measured: six months, throughout the study

  4. Correlation between TUPAST score and probability of psoriatic arthritis in psoriasis patients

    All patients will answer TUPAST questions and all patients will be examined by dermatology and also physical therapy and rehabilitation-rheumatology experts.The diagnosis of psoriatic arthritis (PsA) will be made by CASPAR (Classification criteria for psoriatic arthritis) criteria and ASAS (Assessment of Spondyloarthritis International Society) criteria for spondyloarthritis. Then, sensitivity and specificity of TOPAS 2 will be calculated in our group and the correlation between psoriatic arthritis and screening tool results will be seen.

    Measured: six months, throughout the study

Secondary outcomes (1)

  1. Demographic characteristics demographic characteristics demographic characteristics

    Demographic characteristics of patients will be compared (especially between PsA and non PsA group)

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2020
  2. Study start21 Feb 2020
  3. Primary completion13 Jan 2021
  4. Study completion13 Jan 2021

Resources

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
Cohort
Time perspective
Cross-sectional
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04277832
Sponsor's protocol ID
54022451-050.05.05
Acronym
TUPAST
Status last verified
Jan 2021
First submitted
3 Feb 2020
Last updated
14 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Husni ME, Meyer KH, Cohen DS, Mody E, Qureshi AA. The PASE questionnaire: pilot-testing a psoriatic arthritis screening and evaluation tool. J Am Acad Dermatol. 2007 Oct;57(4):581-7. doi: 10.1016/j.jaad.2007.04.001. Epub 2007 Jul 3.

    PubMed 17610990

  • Ibrahim GH, Buch MH, Lawson C, Waxman R, Helliwell PS. Evaluation of an existing screening tool for psoriatic arthritis in people with psoriasis and the development of a new instrument: the Psoriasis Epidemiology Screening Tool (PEST) questionnaire. Clin Exp Rheumatol. 2009 May-Jun;27(3):469-74.

    PubMed 19604440

  • Chiowchanwisawakit P, Wattanamongkolsil L, Srinonprasert V, Petcharat C, Siriwanarangsun P, Katchamart W. Developing the Thai Siriraj Psoriatic Arthritis Screening Tool and validating the Thai Psoriasis Epidemiology Screening Tool and the Early Arthritis for Psoriatic Patients questionnaire. Rheumatol Int. 2016 Oct;36(10):1459-68. doi: 10.1007/s00296-016-3513-4. Epub 2016 Jun 22.

    PubMed 27333800

  • Audureau E, Roux F, Lons Danic D, Bagot M, Cantagrel A, Dernis E, Gouyette N, Hilliquin P, Jullien D, Liote F, Passeron T, A Richard M, Claudepierre P. Psoriatic arthritis screening by the dermatologist: development and first validation of the 'PURE-4 scale'. J Eur Acad Dermatol Venereol. 2018 Nov;32(11):1950-1953. doi: 10.1111/jdv.14861. Epub 2018 Mar 9.

    PubMed 29430720

  • Duruoz MT, Sanal Toprak C, Ulutatar F. Validation of the Toronto Psoriatic Arthritis Screen II (TOPAS II) questionnaire in a Turkish population. Rheumatol Int. 2018 Feb;38(2):255-259. doi: 10.1007/s00296-017-3871-6. Epub 2017 Nov 7.

    PubMed 29116441

Questions about this trial

What is this clinical trial studying?

An observational study of Psoriasis and Psoriatic Arthritis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).

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 1 inclusion and 2 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 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). 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?

Creation of new tool (TUPAST: Turkish psoriatic arthritis screening tool) for detecting psoriatic arthritis among psoriasis patients (time frame: six months, throughout the study). The study lists 4 primary outcomes in all. 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 NCT04277832, which also lists 5 linked publications.

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 14 Jan 2021.

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