Prospective Study of Classification and Activity Assessment of Psoriatic Arthritis Based on Power Doppler (PD) Ultrasonography (PDUS)

NCT ID: NCT06730334

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2028-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriatic Arthritis Secukinumab Ultrasonography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* PsA patients as defined by CASPAR criteria
* Patients must be able to comply with the visit schedule, treatment plan, laboratory tests and other study procedures
* Patients must be given informed consent

Exclusion Criteria

* History of other arthritis within the last 12 months
* Concomitant disease with acute or chronic infectious diseases
* Pregnancy or laction
* Poorly tolerated with venipuncture required for blood sampling during the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Rui LIU, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Rheumatology and Immunology, Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Rui Rui LIU, MD

Role: CONTACT

Phone: +86 15951871668

Email: [email protected]

Qian ZHANG, MD

Role: CONTACT

Phone: +86 17702501489

Email: [email protected]

Facility Contacts

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Rui LIU, MD

Role: primary

Qian ZHANG, MD

Role: backup

Rui LIU, MD

Role: primary

Qian Zhang, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 34385474 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30709946 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33369655 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32430315 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32521325 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29550766 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18390909 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32862564 (View on PubMed)

Other Identifiers

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2023-SR-415

Identifier Type: -

Identifier Source: org_study_id