Interstitial Lung Disease in Early Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change from baseline for Multi-Dimensional Health Assessment questionnaire (MDHAQ)
研究概览
简要总结
The purpose of this study is to determine how interstitial lung disease can be predicted over time in early rheumatoid arthritis. The investigators will study blood and phlegm samples from participants, along with quality of life questionnaires to determine if and how the presence of ILD may impact the participants quality of life over time.
详细描述
Participation involves 5 study visits over an 18 month timeframe. During each of these visits, a recent medical history and physical exam will take place, blood and phlegm will be collected, quality of life questionnaires will be administered, and a CT-scan of the chest and pulmonary function testing may be performed.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 90 years
- •Diagnosis of "early RA" with or without ILD as defined by ACR/EULAR 2010 criteria and confirmed by a member of the ILD or Rheumatology programs at National Jewish Health (NJH)
- •Able to read, speak, and understand English
- •Able and willing to perform all study related tasks, including returning to NJH every 6 months for an 18 month period of time
排除标准
- •Subjects who do not meet all inclusion criteria
- •Pregnant women
结局指标
主要结局
Change from baseline for Multi-Dimensional Health Assessment questionnaire (MDHAQ)
时间窗: 18 months
Change from baseline for Leicester Cough questionnaire-Acute (LCQ_Acute)
时间窗: 18 months
Change in lung antigen targets in RA-ILD using induced sputum
时间窗: 18 months
Change from baseline for UCSD Medical Center Pulmonary Rehabilitations Program Shortness-of-Breath questionnaire
时间窗: 18 months
Change in anti-CCP antibody test to identify the presence or development of RA in patients with or without ILD
时间窗: 18 months
Change from baseline for Short Form (SF_36) questionnaire
时间窗: 18 months
次要结局
未报告次要终点