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临床试验/NCT05844917
NCT05844917尚未招募不适用

Ultrasound-Based Detection Of Subclinical Arthritis Among Patients With Systemic Lupus

Sohag University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
subclinical arthritis

研究概览

简要总结

The aim of this study is to assess the prevalence and precise grading of US abnormalities of the hand and wrist in asymptomatic patients with SLE, while comparing these findings with a group of patients with SLE with musculoskeletal signs or symptoms and with healthy controls.

详细描述

Systemic Lupus Erythematosus (SLE) is a chronic inflammatory autoimmune disorder associated with a wide range of symptoms and physical findings. It is characterized by loss of tolerance to self-antigens, formation of immune complexes, and an activated type I interferon system .

Joint involvement is one of the most common features of systemic lupus erythematosus (SLE), with up to 95% of patients experiencing arthralgia or arthritis during the course of their disease .

While multiple joints can be affected, nearly 50% of patients report difficulties in daily life performance due to hand symptoms .

Traditionally, SLE arthritis is considered to be mild, reversible and non-erosive, with only 5-15% of cases progressing to deforming arthropathy, either erosive-as in rhupus syndrome (an overlap of SLE with rheumatoid arthritis (RA))-or non-erosive-as in Jaccoud's arthropathy .

In routine clinical practice, joint involvement is usually assessed with physical examination and radiographical studies. However, this approach has been shown to have a low sensitivity for joint abnormalities when compared with ultrasound (US) evaluation or MRI, suggesting that the burden of joint inflammation may be underestimated in the current clinical practice .

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • •Cases diagnosed as SLE according to the 2019 ACR/EULAR classification criteria.
  • •Agreeing to be included in the study
  • •Age >18 years

排除标准

  • •Patients with clinical SLE arthritis
  • •Patients of Rhupus and patients with any collagen disease that causes arthritis other than systemic lupus erythematosus.

研究组 & 干预措施

50 character

Experimental

干预措施: ultrasound (Device)

结局指标

主要结局

subclinical arthritis

时间窗: 6 months

detection of subclinical arthritis by ultrasound in SLE patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aya Abdelsabor Abdelbaset

Sohag Egypt

Sohag University

研究点 (1)

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