Early Rheumatoid Arthritis Lung Disease Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- High Resolution Computed Tomography Chest Scan Results
研究概览
简要总结
Extra-articular (outside of joints) disease occurs in approximately 50% of rheumatoid arthritis (RA) patients, with the lung being a common site of involvement. The goals of this study are to investigate and characterize lung disease and its prevalence in early RA participants. This will be done through pulmonary function and high resolution chest computed tomography (CT), questionnaires, and serum studies. Another goal is to find novel biomarkers, such anti-malondialdehyde-acetaldehyde (MAA) antibodies, as predictors of lung disease in RA participants.
详细描述
Extra-articular (outside of joints) disease occurs in approximately 50% of rheumatoid arthritis (RA) patients, with the lung being a common site of involvement. The purpose of this study is to characterize the prevalence and classification of lung disease in participants with newly diagnosed rheumatoid arthritis by prospectively gathering information on lung imaging and function, comorbidities and novel biomarkers, such as anti-malondialdehyde-acetaldehyde (MAA). Specifically, the study would determine whether (MAA) adduct antibody concentrations predict computed tomography (CT) changes consistent with RA-lung involvement and determine whether anti-MAA antibody concentrations predict pulmonary function abnormalities in forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), and diffusion lung capacity of carbon monoxide (DLCO). An additional goal is to develop a cohort of newly diagnosed RA patients who can be followed long-term through electronic medical record (EMR) surveys, and biobank samples.
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
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19-90 years of age
- •Able to give informed consent
- •Diagnosis of RA by a Rheumatologist using 2010 American College of Rheumatology (ACR) criteria within the past 2 years
排除标准
- •Inflammatory arthritis that does not meet 2010 American College of Rheumatology (ACR) criteria for rheumatoid arthritis (RA)
研究组 & 干预措施
No treatment
No treatment
结局指标
主要结局
High Resolution Computed Tomography Chest Scan Results
时间窗: Baseline (Visit 1 only)
A high resolution computed tomography (CT) chest scan will be done at visit 1 to evaluate the presence of lung disease.
次要结局
- Anti-malondialdehyde acetaldehyde Antibody Concentrations as Abnormality Predictors in Forced Vital Capacity(Baseline and 1 year follow-up)
- Anti-malondialdehyde acetaldehyde Antibody Concentrations as Abnormality Predictors in Forced Expiratory Volume(Baseline and 1 year follow-up)
- Anti-malondialdehyde acetaldehyde Antibody Concentrations as Abnormality Predictors in Diffusion Lung Capacity of Carbon Monoxide(Baseline and 1 year follow-up)