Ultrasound Characteristics of the Salivary Glands in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- OMERACT (Outcome Measures in Rheumatology) B-mode ultrasound homogeneity score greater than or equal to 2 in at least one of the 4 salivary glands
研究概览
简要总结
The prevalence of Sjogren's syndrome (SS) in rheumatoid arthritis (RA) patients varies from 3.5 to 31%. Between 30% and 90% of patients with (RA) have dry eye and/or mouth syndrome. To date, no studies have assessed whether RA patients have echostructural changes in their salivary glands suggestive of SS and the factors associated with these changes.The aim of this study is to investigate if there are changes in the echostructure of the salivary glands of RA patients, especially in patients with dry syndrome.
详细描述
The EchoPR study is an exploratory pathophysiology, cross-sectional, case-control study.
The aim is to study the echo-structure of the salivary glands of patients with RA ( group of 70 patients), in comparison to patients with SS (suspected of strong alteration of the echo-structure)(group of 70 patients) and patients with sicca, asthenia, polyalgia syndrome (SAPS)(group of 70 patients).
After a standard consultation with the rheumatologist, patients in each group will have an salivary gland ultrasound to assess the homogeneity of the echostructure of the parotid and submandibular salivary glands. A salivary flow measurement for 15 minutes and a Schirmer test to determine tear secretion for 5 minutes are also performed. All of these tests are performed during a single visit, so the total study time for the patient is one hour. Patient recruitment is expected to last 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patient, male or female, over 18 years of age, followed in the Rheumatology Department of the Clermont-Ferrand University Hospital, capable of giving informed consent to participate in the research.
- •For RA subjects: Diagnosis of rheumatoid arthritis meeting the ACR/EULAR 2010 classification criteria.
- •For SS subjects: Diagnosis of primary Sjögren's syndrome meeting the ACR/EULAR 2016 criteria.
- •For SAPS subjects: Patients with dry syndrome not meeting the criteria for SS
排除标准
- •Not covered by social security
- •Minors or adults under the protection of the law or under the protection of justice.
- •Pregnant or breastfeeding women
- •Refusal to participate
- •Interference with results or classification bias: secondary causes of dry syndrome: Previous radiotherapy of the face and neck, AIDS, Hepatitis C, Sarcoidosis, Amyloidosis, Hyper-IgG4 syndrome
结局指标
主要结局
OMERACT (Outcome Measures in Rheumatology) B-mode ultrasound homogeneity score greater than or equal to 2 in at least one of the 4 salivary glands
时间窗: 10 minutes
The echostructure of the gland will be graded from 0 to 4 according to the OMERACT score : * 0: normal appearance * Grade 1: minimal inhomogeneity without hypoechoic/anechoic areas * Grade 2: moderate inhomogeneity with focal hypoechoic or anechoic areas * Grade 3 severe inhomogeneity with diffuse hypoechoic or anechoic areas of the whole gland or fibrous gland
次要结局
- Color Doppler ultrasound vascularity score of OMERACT greater than or equal to 2 on at least one of the 4 salivary glands(10 minutes)
- Surface of the submandibular salivary glands(2 minutes)
- Length and width of the parotid glands(2 minutes)
- Length of the submandibular glands(2 minutes)