Clinical trial NCT06730334: Prospective Study of Classification and Activity Assessment of Psoriatic Arthritis Based on Power Doppler (PD) Ultrasonography (PDUS)
Official title: A Single Centre Prospective Cohort Study of Classification and Activity Assessment of Psoriatic Arthritis Based on Power Doppler (PD) Ultrasonography (PDUS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psoriatic Arthritis
Secukinumab
Ultrasonography
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult PsA patients as defined by CASPAR criteria

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.


Eligibility criteria: 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

Primary outcomes:
measure: Madrid Sonographic Enthesitis Index (MASEI)
timeFrame: 12 weeks
measure: DACTylitis glObal Sonographic (DACTOS)
timeFrame: 12 weeks
Secondary outcomes:
measure: ACR20 Response
timeFrame: 12 weeks
measure: Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR)
timeFrame: 12 weeks
measure: Disease Activity Score 28-C-reactive protein (DAS28-CRP)
timeFrame: 12 weeks
measure: Disease Activity in PSoriatic Arthritis (DAPSA)
timeFrame: 12 weeks
measure: ACR50 Response
timeFrame: 52 weeks
measure: ACR70 Response
timeFrame: 52 weeks
measure: Minimal disease activity (MDA)
timeFrame: 52 weeks
measure: Bone destruction
timeFrame: 52 weeks
measure: Bone destruction
timeFrame: 104 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Rheumatology and Immunology, Jiangsu Province Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
Study officials:
References:
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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.
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.
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.
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.
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.