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

Recruiting

• Conditions: Psoriatic Arthritis; Secukinumab; Ultrasonography

• Registration Number: NCT06730334
• Lead Sponsor: Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-11
• Study First Posted: 2024-12-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2026-09-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Madrid Sonographic Enthesitis Index (MASEI)	12 weeks	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.
DACTylitis glObal Sonographic (DACTOS)	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
ACR20 Response	12 weeks	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.
Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR)	12 weeks	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)
Disease Activity Score 28-C-reactive protein (DAS28-CRP)	12 weeks	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)
Disease Activity in PSoriatic Arthritis (DAPSA)	12 weeks	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
ACR50 Response	52 weeks	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.
ACR70 Response	52 weeks	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.
Minimal disease activity (MDA)	52 weeks	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)
Bone destruction	104 weeks	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).

Trial Locations

Locations (2)

Department of Rheumatology and Immunology, Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China