NCT04277832

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

February 21, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2021

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

11 months

First QC Date

February 3, 2020

Last Update Submit

January 13, 2021

Conditions

Keywords

psoriasispsoriatic arthritisscreening tool

Outcome Measures

Primary Outcomes (4)

  • 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.

    six months, throughout the study

  • 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.

    six months, throughout the study

  • 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.

    six months, throughout the study

  • 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.

    six months, throughout the study

Secondary Outcomes (1)

  • Demographic characteristics demographic characteristics demographic characteristics

    six months

Study Arms (1)

single arm

Group 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.

Diagnostic Test: Questionary

Interventions

QuestionaryDIAGNOSTIC_TEST

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

single arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over 18 years with psoriasis

You may qualify if:

  • Psoriasis confirmed by dermatologist

You may not qualify if:

  • Unable to consent and understand
  • Known other rheumatological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf Univesity

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 17610990BACKGROUND
  • 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.

    PMID: 19604440BACKGROUND
  • 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.

    PMID: 27333800BACKGROUND
  • 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.

    PMID: 29430720BACKGROUND
  • 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.

MeSH Terms

Conditions

PsoriasisArthritis, Psoriatic

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint Diseases

Study Officials

  • Nahide MD Onsun, Prof

    Bezmialem University

    STUDY DIRECTOR
  • Begüm MD Güneş

    Bezmialem University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2020

First Posted

February 20, 2020

Study Start

February 21, 2020

Primary Completion

January 13, 2021

Study Completion

January 13, 2021

Last Updated

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations