Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 2
- 主要终点
- Presence of interstitial lung disease on high resolution CT (HRCT) chest imaging
研究概览
简要总结
The overall goal of this study is to define the phenotype of Interstitial Lung Disease (ILD), and identify factors that predict radiologic progression in those with subclinical RA-ILD, in patients with rheumatoid arthritis (RA). The investigators hypothesize that there are common core elements (e.g. clinical features, genetic variants, and/or biologic markers) between other forms of ILD (e.g. idiopathic pulmonary fibrosis, IPF) and subclinical RA-ILD that places individuals at risk for the development of lung disease.
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
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 45years old
- •Diagnosis of RA using the 2010 American College of Rheumatology (ACR) criteria
排除标准
- •Inability to give informed consent
- •Pregnant women
- •History of interstitial lung disease
- •Evidence of other causes of diffuse parenchymal lung disease such as infection, drug toxicity, other autoimmune processes, etc.
- •Subjects over the age of 90 years old or less than 45 years old
研究组 & 干预措施
RA with Sub-clinical ILD
Subjects will be followed annually until study closure.
Assessments are as follows:
- Clinical (Annual): Demographics, health-related behaviors, co-morbidities, medications, respiratory symptoms, rheumatologic assessment, quality of life
- Physiologic (3-5 yrs FU): Lung function on Pulmonary Function Test (PFT)
- Radiologic (3-5 yrs FU): HRCT scan of chest
- Genetic (3-5 yrs FU): Blood sample collection for RNA
- Biologic (3-5 yrs FU): Blood sample collection for other blood markers
RA with No-ILD
Subjects will be followed annually until study closure.
Assessments are as follows:
- Clinical (Annual): Demographics, health-related behaviors, co-morbidities, medications, respiratory symptoms, rheumatologic assessment, quality of life
- Physiologic (3-5 yrs FU): Lung function on Pulmonary Function Test (PFT)
- Radiologic (3-5 yrs FU): HRCT scan of chest
- Genetic (3-5 yrs FU): Blood sample collection for RNA
- Biologic (3-5 yrs FU): Blood sample collection for other blood markers
Note: Certain follow-up procedures may not occur for every subject and will be determined by the research team.
结局指标
主要结局
Presence of interstitial lung disease on high resolution CT (HRCT) chest imaging
时间窗: 3-5 years
HRCT scans of the chest will be interpreted by two radiologists and the presence or absence of interstitial lung abnormality will be recorded. When present, abnormalities will be categorized as absent, equivocal, non-fibrotic, or fibrotic, and the extent of any reticular abnormalities will be graded on an 11-point scale (0, 1-10%, 11-20%, etc.). Additionally, the presence or absence of airway disease, centrilobular thickening, mosaic attenuation, and air trapping will be recorded.
次要结局
- Outcome of airways disease(3-5 Years)
- Progression of lung disease over time(3-5 Years)
- Impact of subclinical RA-ILD on health-related quality of life in RA(3-5 Years)