Distal Phalangeal Bone Involvement Observed by High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) in Patients With Nail Psoriasis
试验速览
- 阶段
- 不适用
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- distal phalangeal bone erosion of the 2 index fingers of the hand
研究概览
简要总结
Nearly 30% of patients with cutaneous psoriasis (PsO) developed psoriatic arthritis (PsA). Among these patients 20 % will have severe destructive arthritis. The risk of developing PsA is significantly higher in patients with nail involvement (OR = 2.24; 95% CI [1.26-3.98]). The risk is particularly high for the peripheral form of PsA and onycholysis (OR=2.80; 95% CI [1.34-5.85]).
Thus the investigators wanted to test the hypothesis that onycholysis, in patients without PsA, is a potential clinical marker of subclinical distal enthesopathy and, by extension, of bone micro-structural alterations.
Patients and Methods
The investigators will recruit 4 groups of subjects:
- Patients with peripheral PsA,
- Patients with psoriatic nail onycholysis,
- Patients with PsO only
- Healthy match control subjects. The investigators will assess the presence of enthesopathy by ultrasonography and bone structural damages (by HR-pQCT) in all subjects at baseline and 4 years.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adults over 18 years and until 65 years
- •both gender
- •covered by the French National Insurance
- •subjects entering one of the 4 groups.
排除标准
- •Treatment by biological agents are an exclusion criteria for PsO, onycholysis and control patients.
- •Pregnant women
结局指标
主要结局
distal phalangeal bone erosion of the 2 index fingers of the hand
时间窗: at baseline and after 4 years of follow-up
assessment by HR-pQCT
次要结局
- enthesopathy of the 2 index fingers of the hand(at baseline and after 4 years of follow-up)
- Rheumatoid factors(Biomarkers are assessed at baseline)