Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:03 PM
Study NCT ID:
NCT06730334
Status:
RECRUITING
Last Update Posted:
2024-12-20
First Post:
2024-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study of Classification and Activity Assessment of Psoriatic Arthritis Based on Power Doppler (PD) Ultrasonography (PDUS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'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'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-18', 'studyFirstSubmitDate': '2024-12-06', 'studyFirstSubmitQcDate': '2024-12-11', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Madrid Sonographic Enthesitis Index (MASEI)', 'timeFrame': '12 weeks', 'description': 'MASEI includes six entheses (the bilateral triceps, the quadriceps, both proximal and distal patellar and Achilles tendons and the proximal insertion of the plantar aponeurosis) and six elementary lesions (structure, thickening, erosion, enthesophytes, PD and bursa), with weighted punctuations that can be summed to a maximum score of 136.'}, {'measure': 'DACTylitis glObal Sonographic (DACTOS)', 'timeFrame': '12 weeks', 'description': 'DACTOS score will be used for every affected digit. There are four keys in DACTOS scoring: PTI（Peritendon extensor inflammation） evaluated in B-mode and PD at MCP and PIP joints level (maximum score, 4) STOe（Soft tissue oedema） evaluated in B-mode and PD in the most severely affected area of the digit (maximum score, 6) flexor tenosynovitis evaluated in B-mode and PD in the most severely affected area of the digit (maximum score, 6) EULAR-OMERACT combined score for synovitis evaluated at the MCP, PIP and DIP joints (maximum score, 9) DACTOS score summation ranges from 0 to 25 points. A DACTOS value\\<3 identified the US response.'}], 'secondaryOutcomes': [{'measure': 'ACR20 Response', 'timeFrame': '12 weeks', 'description': "American College of Rheumatology (ACR) Response Criteria: An ACR20 response is defined as improvement of ≥20% from Baseline in the number of tender and swollen joints (from an analysis of 78 and 76 joints, respectively) and in three of the following five domains: a patient's global assessment of disease, a physician's global assessment of disease, and a patient's assessment of pain (all three measures evaluated on a visual-analogue scale of 0 to 100 mm), disability score on the Health Assessment Questionnaire-Disability Index (HAQ-DI; scores range from 0 to 3; higher scores indicate greater disability), and acute-phase reactants, as measured by high-sensitivity C-reactive protein (CRP) levels or erythrocyte sedimentation rate. An ACR50 response is defined as ≥50% improvement, and an ACR70 response is defined as ≥70% improvement in the above criteria."}, {'measure': 'Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR)', 'timeFrame': '12 weeks', 'description': 'DAS28-ESR = 0.56 \\* sqrt(tender28) + 0.28 \\* sqrt(swollen28) + 0.70 \\* ln(ESR) + 0.014 \\* GH. GH(mm)is general health using a visual analog scale (VAS) measuring general health (VAS-GH; 0 = best, 100 = worst)'}, {'measure': 'Disease Activity Score 28-C-reactive protein (DAS28-CRP)', 'timeFrame': '12 weeks', 'description': 'DAS28-CRP=0.56 \\* sqrt(tender28) + 0.28 \\* sqrt(swollen28)+0.36×ln （CRP+1）+0.014\\* GH+0.96. GH(mm)is general health using a visual analog scale (VAS) measuring general health (VAS-GH; 0 = best, 100 = worst)'}, {'measure': 'Disease Activity in PSoriatic Arthritis (DAPSA)', 'timeFrame': '12 weeks', 'description': 'DAPSA score was calculated as the sum of: (1) SJC (range: 0-66), (2) TJC (range: 0-68), (3) patient pain assessment VAS measurement in centimeters (range: 0-10), (4) patient global assessment VAS measurement in centimeters (range: 0-10), and (5) serum acute-phase response, represented by CRP level in mg/dL (range: 0-10 mg/dL). The cut-off points for defining different disease activity are: ≤4, DAPSA-REM; \\>4 to ≤14, DAPSA-LDA; ≤14, DAPSA-REM+LDA; \\>14 to ≤28, DAPSA-MoDA; DAPSA-HAD, \\>28'}, {'measure': 'ACR50 Response', 'timeFrame': '52 weeks', 'description': "American College of Rheumatology (ACR) Response Criteria: An ACR20 response is defined as improvement of ≥20% from Baseline in the number of tender and swollen joints (from an analysis of 78 and 76 joints, respectively) and in three of the following five domains: a patient's global assessment of disease, a physician's global assessment of disease, and a patient's assessment of pain (all three measures evaluated on a visual-analogue scale of 0 to 100 mm), disability score on the Health Assessment Questionnaire-Disability Index (HAQ-DI; scores range from 0 to 3; higher scores indicate greater disability), and acute-phase reactants, as measured by high-sensitivity C-reactive protein (CRP) levels or erythrocyte sedimentation rate. An ACR50 response is defined as ≥50% improvement, and an ACR70 response is defined as ≥70% improvement in the above criteria."}, {'measure': 'ACR70 Response', 'timeFrame': '52 weeks', 'description': "American College of Rheumatology (ACR) Response Criteria: An ACR20 response is defined as improvement of ≥20% from Baseline in the number of tender and swollen joints (from an analysis of 78 and 76 joints, respectively) and in three of the following five domains: a patient's global assessment of disease, a physician's global assessment of disease, and a patient's assessment of pain (all three measures evaluated on a visual-analogue scale of 0 to 100 mm), disability score on the Health Assessment Questionnaire-Disability Index (HAQ-DI; scores range from 0 to 3; higher scores indicate greater disability), and acute-phase reactants, as measured by high-sensitivity C-reactive protein (CRP) levels or erythrocyte sedimentation rate. An ACR50 response is defined as ≥50% improvement, and an ACR70 response is defined as ≥70% improvement in the above criteria."}, {'measure': 'Minimal disease activity (MDA)', 'timeFrame': '52 weeks', 'description': 'MDA response was defined as achievement of at least five of the following seven criteria: TJC ≤1 (of 68), SJC ≤1 (of 66), PASI ≤1 or PsO affecting \\<3% BSA, patient pain VAS ≤15 mm, patient global disease activity VAS ≤20 mm, HAQ-DI ≤0.5, and tender entheseal points ≤1. Patients who met all seven MDA criteria were classified as achieving VLDA (very low disease activity)'}, {'measure': 'Bone destruction', 'timeFrame': '52 weeks', 'description': 'New bone destruction in x-ray, MRI, CT scan and ultrasonography. Based on New OMERACT definitions of US-detected pathologies, defined as intra- and/or extraarticular discontinuity of bone surface (visible in 2 perpendicular planes).'}, {'measure': 'Bone destruction', 'timeFrame': '104 weeks', 'description': 'New bone destruction in x-ray, MRI, CT scan and ultrasonography. Based on New OMERACT definitions of US-detected pathologies, defined as intra- and/or extraarticular discontinuity of bone surface (visible in 2 perpendicular planes).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriatic Arthritis', 'Secukinumab', 'Ultrasonography']}, 'referencesModule': {'references': [{'pmid': '34385474', 'type': 'BACKGROUND', 'citation': 'FitzGerald O, Ogdie A, Chandran V, Coates LC, Kavanaugh A, Tillett W, Leung YY, deWit M, Scher JU, Mease PJ. Psoriatic arthritis. Nat Rev Dis Primers. 2021 Aug 12;7(1):59. doi: 10.1038/s41572-021-00293-y.'}, {'pmid': '30709946', 'type': 'BACKGROUND', 'citation': "Bruyn GA, Iagnocco A, Naredo E, Balint PV, Gutierrez M, Hammer HB, Collado P, Filippou G, Schmidt WA, Jousse-Joulin S, Mandl P, Conaghan PG, Wakefield RJ, Keen HI, Terslev L, D'Agostino MA; OMERACT Ultrasound Working Group. OMERACT Definitions for Ultrasonographic Pathologies and Elementary Lesions of Rheumatic Disorders 15 Years On. J Rheumatol. 2019 Oct;46(10):1388-1393. doi: 10.3899/jrheum.181095. Epub 2019 Feb 1."}, {'pmid': '33369655', 'type': 'BACKGROUND', 'citation': 'Girolimetto N, Zabotti A, Tinazzi I, Possemato N, Costa L, Batticciotto A, Canzoni M, Citriniti G, De Lucia O, Figus F, Idolazzi L, McConnel R, Peluso R, Sakellariou G, Tullio A, Salvarani C, Scarpa R, Iagnocco A, Caso F, Macchioni P. Sensitivity to change and clinical correlations of the novel DACtylitis glObal Sonographic (DACTOS) score in psoriatic arthritis. Rheumatology (Oxford). 2021 Sep 1;60(9):4103-4111. doi: 10.1093/rheumatology/keaa885.'}, {'pmid': '32430315', 'type': 'BACKGROUND', 'citation': 'Zabotti A, Sakellariou G, Tinazzi I, Idolazzi L, Batticciotto A, Canzoni M, Carrara G, De Lucia O, Figus F, Girolimetto N, Macchioni P, McConnell R, Possemato N, Iagnocco A. Novel and reliable DACTylitis glObal Sonographic (DACTOS) score in psoriatic arthritis. Ann Rheum Dis. 2020 Aug;79(8):1037-1043. doi: 10.1136/annrheumdis-2020-217191. Epub 2020 May 19.'}, {'pmid': '32521325', 'type': 'BACKGROUND', 'citation': 'Coates LC, Nash P, Kvien TK, Gossec L, Mease PJ, Rasouliyan L, Pricop L, Jugl SM, Gandhi KK, Gaillez C, Smolen JS. Comparison of remission and low disease activity states with DAPSA, MDA and VLDA in a clinical trial setting in psoriatic arthritis patients: 2-year results from the FUTURE 2 study. Semin Arthritis Rheum. 2020 Aug;50(4):709-718. doi: 10.1016/j.semarthrit.2020.03.015. Epub 2020 May 15.'}, {'pmid': '29550766', 'type': 'BACKGROUND', 'citation': 'Mease P, van der Heijde D, Landewe R, Mpofu S, Rahman P, Tahir H, Singhal A, Boettcher E, Navarra S, Meiser K, Readie A, Pricop L, Abrams K. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study. Ann Rheum Dis. 2018 Jun;77(6):890-897. doi: 10.1136/annrheumdis-2017-212687. Epub 2018 Mar 17.'}, {'pmid': '18390909', 'type': 'BACKGROUND', 'citation': 'de Miguel E, Cobo T, Munoz-Fernandez S, Naredo E, Uson J, Acebes JC, Andreu JL, Martin-Mola E. Validity of enthesis ultrasound assessment in spondyloarthropathy. Ann Rheum Dis. 2009 Feb;68(2):169-74. doi: 10.1136/ard.2007.084251. Epub 2008 Apr 7.'}, {'pmid': '32862564', 'type': 'BACKGROUND', 'citation': 'Greenmyer JR, Stacy JM, Sahmoun AE, Beal JR, Diri E. DAS28-CRP Cutoffs for High Disease Activity and Remission Are Lower Than DAS28-ESR in Rheumatoid Arthritis. ACR Open Rheumatol. 2020 Sep;2(9):507-511. doi: 10.1002/acr2.11171. Epub 2020 Aug 29.'}]}, 'descriptionModule': {'briefSummary': 'Psoriatic arthritis (PsA) is a complex inflammatory disease with heterogeneous clinical features, which complicates psoriasis in 30% of patients. PsA involves multiple tissues and clinical domains including skins and nails as well as arthritis, spondylitis, enthesitis, and dactylitis. Power Doppler (PD) ultrasonography (PDUS) is a sensitive non-invasive imaging technology used to assess disease activity and treatment response in PsA. This is a prospective, observational, open-label study to investigate disease activity, therapeutic response and bone destruction based on ultrasonography findings in patients with PsA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult PsA patients as defined by CASPAR criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PsA patients as defined by CASPAR criteria\n* Patients must be able to comply with the visit schedule, treatment plan, laboratory tests and other study procedures\n* Patients must be given informed consent\n\nExclusion Criteria:\n\n* History of other arthritis within the last 12 months\n* Concomitant disease with acute or chronic infectious diseases\n* Pregnancy or laction\n* Poorly tolerated with venipuncture required for blood sampling during the study'}, 'identificationModule': {'nctId': 'NCT06730334', 'briefTitle': 'Prospective Study of Classification and Activity Assessment of Psoriatic Arthritis Based on Power Doppler (PD) Ultrasonography (PDUS)', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'A Single Centre Prospective Cohort Study of Classification and Activity Assessment of Psoriatic Arthritis Based on Power Doppler (PD) Ultrasonography (PDUS)', 'orgStudyIdInfo': {'id': '2023-SR-415'}}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rui LIU, MD', 'role': 'CONTACT', 'email': 'liurui_nanjing@163.com', 'phone': '+86 15951871668'}, {'name': 'Qian ZHANG, MD', 'role': 'CONTACT', 'email': 'zhq19921012@163.com', 'phone': '+86 17702501489'}, {'name': 'Rui LIU, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Qian ZHANG, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Rheumatology and Immunology, Jiangsu Province Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rui LIU, MD', 'role': 'CONTACT', 'email': 'liurui_nanjing@163.com', 'phone': '+86 15951871668'}, {'name': 'Qian Zhang, MD', 'role': 'CONTACT', 'email': 'zhq19921012@163.com', 'phone': '+86 17702501489'}], 'facility': 'Jiangsu Province Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Rui Rui LIU, MD', 'role': 'CONTACT', 'email': 'liurui_nanjing@163.com', 'phone': '+86 15951871668'}, {'name': 'Qian ZHANG, MD', 'role': 'CONTACT', 'email': 'zhq19921012@163.com', 'phone': '+86 17702501489'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Rui LIU, MD', 'investigatorAffiliation': 'The First Affiliated Hospital with Nanjing Medical University'}}}}