The Diagnostic Ultrasound Enthesitis Tool (DUET) Study: Development of a Sonographic Enthesitis Score for Early Diagnosis of Psoriatic Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 419
- 试验地点
- 1
- 主要终点
- DUET scoring system for early diagnosis of PsA
研究概览
简要总结
Psoriatic arthritis (PsA) is a type of joint disease that can lead to severe joint damage and disability within the first few years of the disease. This is why early detection and treatment of the disease is essential to prevent serious joint damage and improve long-term outcomes in these patients. However, there is currently no reliable way to tell the difference between PsA and other types of joint disease. This makes it difficult to detect PsA early. Enthesitis is an inflammation of the area where muscle tendons and ligaments attach to bones. Enthesitis is a key feature in PsA and can be easily detected using ultrasonography. The aim of this research study is to develop a system to evaluate enthesitis using ultrasonography, which can be used as an effective tool in the early detection of PsA. This will help in providing patients with early treatment to prevent further joint damage.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Able to provide an informed consent
- •Specific Inclusion Criteria for PsA:
- •Meets the CASPAR criteria for PsA
- •Early PsA - Less than 5 years from a rheumatologist diagnosis of PsA
- •Specific Inclusion Criteria for Psoriasis:
- •Dermatologist confirmed diagnosis of psoriasis
- •No prior diagnosis of PsA or signs of PsA on physical examination
- •Psoriasis Epidemiology Screening Tool (PEST) score < 3
- •Specific Inclusion Criteria for non-inflammatory rheumatic disease:
- •Referred to rheumatology for musculoskeletal symptoms such as joint pain, stiffness, back pain
- •No evidence of inflammatory rheumatic condition including rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus, scleroderma, gout, septic arthritis or recent joint trauma/surgery
- •No psoriasis
- •No inflammatory bowel disease
排除标准
- •Using any biologic medications including Tumor Necrosis Factor (TNF) inhibitors, Interleukin (IL)-17 inhibitors, IL-23 inhibitors, IL-12/23 inhibitors, Janus Kinase (JAK) inhibitors
- •Prednisone ≥ 7.5 mg/day
结局指标
主要结局
DUET scoring system for early diagnosis of PsA
时间窗: From beginning to end of physical & ultrasound assessment, up to 1.5 hours
To derive the DUET scoring system for distinguishing PsA from non-inflammatory disease using musculoskeletal ultrasound. The investigators will report the optimal set of weighted parameters and their performance measures (area under the curve, suggested cut-off points, sensitivity, and specificity).
次要结局
- Assess the construct validity of the new DUET scoring system(From beginning to end of physical & ultrasound assessment, up to 1.5 hours)