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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04277832
Other study ID # 54022451-050.05.05
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 21, 2020
Est. completion date January 13, 2021

Study information

Verified date January 2021
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date January 13, 2021
Est. primary completion date January 13, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Psoriasis confirmed by dermatologist Exclusion Criteria: - Unable to consent and understand - Known other rheumatological disease

Study Design


Intervention

Diagnostic Test:
Questionary
All patients will answer two different questionary (TUPAST, TOPAS 2)

Locations

Country Name City State
Turkey Bezmialem Vakif Univesity Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Audureau E, Roux F, Lons Danic D, Bagot M, Cantagrel A, Dernis E, Gouyette N, Hilliquin P, Jullien D, Lioté 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. — View Citation

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. — View Citation

Duruöz 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. — View Citation

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. Epub 2007 Jul 3. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 Demographic characteristics demographic characteristics demographic characteristics Demographic characteristics of patients will be compared (especially between PsA and non PsA group) six months
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