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

NCT06730334 | Recruiting

• 1 other identifier: 2023-SR-415
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Psoriatic Arthritis; Secukinumab; Ultrasonography

Outcome Measures

Primary Outcomes (2)

• Madrid Sonographic Enthesitis Index (MASEI)

  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.

  12 weeks

• DACTylitis glObal Sonographic (DACTOS)

  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.

  12 weeks

Secondary Outcomes (9)

• ACR20 Response

  12 weeks

• Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR)

  12 weeks

• Disease Activity Score 28-C-reactive protein (DAS28-CRP)

  12 weeks

• Disease Activity in PSoriatic Arthritis (DAPSA)

  12 weeks

• ACR50 Response

  52 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult PsA patients as defined by CASPAR criteria

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (2)

Department of Rheumatology and Immunology, Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (9)

• 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: 34385474 BACKGROUND

• 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: 30709946 BACKGROUND

• 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: 33369655 BACKGROUND

• 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: 32430315 BACKGROUND

• 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: 32521325 BACKGROUND

• 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: 29550766 BACKGROUND

• 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: 18390909 BACKGROUND

• 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.

  PMID: 32862564 BACKGROUND

• Zhang Q, Mao C, Lu F, Wu Y, Ke Y, Liu R. Ultrasound dactylitis predicts bone erosion in early psoriatic arthritis: A longitudinal cohort study. Eur J Radiol. 2026 Jan 28;196:112704. doi: 10.1016/j.ejrad.2026.112704. Online ahead of print.

  PMID: 41621380 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Rui Rui LIU, MD

CONTACT

+86 15951871668; liurui_nanjing@163.com

Qian ZHANG, MD

CONTACT

+86 17702501489; zhq19921012@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 12, 2024
• Study Start: September 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

CN (2)