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Psoriatic ArthritisNCT06730334

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

An observational study of Psoriatic Arthritis and Secukinumab, run by Nanjing Medical University at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriatic Arthritis, Secukinumab, Ultrasonography
How many people
400 participants
Where
2 sitesChina
Study dates
1 Sep 2023to 1 Jun 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult PsA patients as defined by CASPAR criteria

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Rui Rui LIU, MD contact

+86 15951871668

liurui_nanjing@163.com

Qian ZHANG, MD contact

+86 17702501489

zhq19921012@163.com

China2 sites, 2 recruiting

  • Department of Rheumatology and Immunology, Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Rui LIU, MD, +86 15951871668, liurui_nanjing@163.com

    Qian ZHANG, MD, +86 17702501489, zhq19921012@163.com

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Rui LIU, MD, +86 15951871668, liurui_nanjing@163.com

    Qian Zhang, MD, +86 17702501489, zhq19921012@163.com

    Recruiting

Other trials in China

About this study

Official title: A Single Centre Prospective Cohort Study of Classification and Activity Assessment of Psoriatic Arthritis Based on Power Doppler (PD) Ultrasonography (PDUS)

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.

Medical subject headings
Arthritis, Psoriatic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

Secondary outcomes (9)

  1. ACR20 Response

    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.

    Measured: 12 weeks

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

    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)

    Measured: 12 weeks

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

    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)

    Measured: 12 weeks

  4. Disease Activity in PSoriatic Arthritis (DAPSA)

    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

    Measured: 12 weeks

  5. ACR50 Response

    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.

    Measured: 52 weeks

  6. ACR70 Response

    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.

    Measured: 52 weeks

  7. Minimal disease activity (MDA)

    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)

    Measured: 52 weeks

  8. Bone destruction

    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).

    Measured: 52 weeks

  9. Bone destruction

    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).

    Measured: 104 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2024
  2. Study start1 Sep 2023
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06730334
Sponsor's protocol ID
2023-SR-415
Status last verified
Dec 2024
First submitted
6 Dec 2024
Last updated
20 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34385474

  • 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.

    PubMed 30709946

  • 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.

    PubMed 33369655

  • 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.

    PubMed 32430315

  • 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.

    PubMed 32521325

  • 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.

    PubMed 29550766

  • 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.

    PubMed 18390909

  • 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.

    PubMed 32862564

  • 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 Mar;196:112704. doi: 10.1016/j.ejrad.2026.112704. Epub 2026 Jan 28.

    PubMed 41621380

Questions about this trial

What is this clinical trial studying?

An observational study of Psoriatic Arthritis and Secukinumab, run by Nanjing Medical University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rui Rui LIU, MD (+86 15951871668, liurui_nanjing@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Madrid Sonographic Enthesitis Index (MASEI) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06730334, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.

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