Defining the Molecular and Radiologic Phenotype of Progressive RA Interstitial Lung Disease (MOUNTAIN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 4
- 主要终点
- Evaluating the role of novel quantitative imaging
研究概览
简要总结
A study to identify patients with Rheumatoid Arthritis - Associated Interstitial Lung Disease (RA-ILD) that are at the highest risk for progression.
The goal of the investigators is to recruit a group of patients with RA-ILD and collect information to help us understand more about disease progression. The investigators will do this using a combination of clinical, radiologic, and biologic features.
详细描述
The central hypothesis is that novel quantitative imaging and specific blood markers will be associated with progressive RA-ILD. The hypothesis will be tested through collection and analysis of peripheral blood, in addition to the analysis of HRCT (high-resolution computed tomography) scans performed as standard of care (clinical) on research subjects.
Procedures performed:
Baseline Year 0: Blood sample, buccal (cheek) swab, questionnaires and if performed clinically - Pulmonary Function tests, 6 Minute Walk Test, and HRCT scan of lungs
Every 4 months (at clinic visit): Blood sample, questionnaires
Year 1 and Year 2 Follow-ups: Blood sample, buccal (cheek) swab, questionnaires and if performed clinically - Pulmonary Function tests, 6 Minute Walk Test, and HRCT scan of lungs
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
- •Multidisciplinary diagnosis of RA-ILD based on the 2010 American College of Rheumatology criteria
- •18 years of age or older
排除标准
- •Prior medication treatment specifically for RA-ILD
- •Inability to give informed consent
- •Pregnant women
结局指标
主要结局
Evaluating the role of novel quantitative imaging
时间窗: 5-years
Through evaluation of baseline CT scans and application of novel quantitative technology, investigators will monitor for specific patterning to identify patients at risk for progression.
次要结局
- Comparing peripheral blood telomere length (PB-TL)(5-years)
- Defining peripheral blood transcriptomic profiles(5-years)
- Exploring if a composite profile more accurately identifies progressive RA-ILD(5-years)