A Single Centre Prospective Cohort Study of Classification and Activity Assessment of Psoriatic Arthritis Based on Power Doppler (PD) Ultrasonography (PDUS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Madrid Sonographic Enthesitis Index (MASEI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Madrid Sonographic Enthesitis Index (MASEI)
时间窗: 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)
时间窗: 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.
次要结局
- 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)
- ACR70 Response(52 weeks)
- Minimal disease activity (MDA)(52 weeks)
- Bone destruction(104 weeks)
研究者
Rui LIU, MD
MD
The First Affiliated Hospital with Nanjing Medical University