Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-02-19 @ 11:29 AM
Study NCT ID:
NCT04277832
Status:
COMPLETED
Last Update Posted:
2021-01-14
First Post:
2020-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating of New Screening Tool for Arthritis* in Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-13', 'studyFirstSubmitDate': '2020-02-03', 'studyFirstSubmitQcDate': '2020-02-19', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Creation of new tool (TUPAST: Turkish psoriatic arthritis screening tool) for detecting psoriatic arthritis among psoriasis patients', 'timeFrame': 'six months, throughout the study', 'description': '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.'}, {'measure': 'Correlation between TOPAS 2 score and probability of psoriatic arthritis in psoriasis patients', 'timeFrame': 'six months, throughout the study', 'description': '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.'}, {'measure': 'Comparison of the reliability of the TUPAST and TOPAS 2', 'timeFrame': 'six months, throughout the study', 'description': 'All patients will answer TUPAST and TOPAS 2 at the same time. According to statistical results, reliability of this two tool will be compared.'}, {'measure': 'Correlation between TUPAST score and probability of psoriatic arthritis in psoriasis patients', 'timeFrame': 'six months, throughout the study', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Demographic characteristics demographic characteristics demographic characteristics', 'timeFrame': 'six months', 'description': 'Demographic characteristics of patients will be compared (especially between PsA and non PsA group)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['psoriasis', 'psoriatic arthritis', 'screening tool'], 'conditions': ['Psoriasis', 'Psoriatic Arthritis']}, 'referencesModule': {'references': [{'pmid': '17610990', 'type': 'BACKGROUND', '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. doi: 10.1016/j.jaad.2007.04.001. Epub 2007 Jul 3.'}, {'pmid': '19604440', 'type': 'BACKGROUND', '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.'}, {'pmid': '27333800', 'type': 'BACKGROUND', '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.'}, {'pmid': '29430720', 'type': 'BACKGROUND', 'citation': "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': '29116441', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates a new screening tool for arthritis in psoriasis and compares its reliability with well-known screening tool (TOPAS 2).', 'detailedDescription': '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.\n\nA 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients over 18 years with psoriasis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Psoriasis confirmed by dermatologist\n\nExclusion Criteria:\n\n* Unable to consent and understand\n* Known other rheumatological disease'}, 'identificationModule': {'nctId': 'NCT04277832', 'acronym': 'TUPAST', 'briefTitle': 'Evaluating of New Screening Tool for Arthritis* in Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Evaluation of a New Screening Tool (TUPAST) for Psoriatic Arthritis in Turkish Psoriasis Population and Comparison With TOPAS 2 for Validation of TUPAST', 'orgStudyIdInfo': {'id': '54022451-050.05.05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'single arm', 'description': '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.', 'interventionNames': ['Diagnostic Test: Questionary']}], 'interventions': [{'name': 'Questionary', 'type': 'DIAGNOSTIC_TEST', 'description': 'All patients will answer two different questionary (TUPAST, TOPAS 2)', 'armGroupLabels': ['single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bezmialem Vakıf Univesity', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Nahide MD Onsun, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bezmialem University'}, {'name': 'Begüm MD Güneş', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bezmialem University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}