Change in Serum and Sputum Biomarkers Over Time in the Development of Rheumatoid Arthritis-associated Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Define which patients with RA (or pre-RA) are at greatest risk for developing RA-related lung disease (LD).
研究概览
简要总结
The purpose of this study is to investigate the link between the lungs and rheumatoid arthritis (RA). Additionally, to understand why RA patients get lung disease, how to treat, and prevent the disease.
详细描述
This study is to learn more about the risk factors for the development of lung disease among patients with rheumatoid arthritis (RA), an auto-immune disease. Additionally, those at heightened risk of developing RA such as in the pre-RA period. This is a prospective and retrospective study, which 420 patients will be enrolled into the study. In-person participation will be up to 4 years, completing different standard of care assessments yearly. Additionally, quality of life questionnaires will be completed every 6 months at 4 time points. Lastly, an extended follow-up will be performed yearly for an additional 6 years, an overall 10 year participation.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 80 years
排除标准
- •Subjects who do not speak English
- •Subjects without the capacity to sign the informed consent form (ICF)
- •Pregnant women
结局指标
主要结局
Define which patients with RA (or pre-RA) are at greatest risk for developing RA-related lung disease (LD).
时间窗: 10 years
次要结局
未报告次要终点