Treatment Outcome and Prognostic Factors for RA Patients With Interstitial Lung Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The objectives of this single center, prospective, non-interventional cohort is to understand patient characteristics, general treatment patterns, effectiveness/safety of conventional disease modifying antirheumatic drug (DMARD) and biologic DMARD treatments in rheumatoid arthritis patients with ILD in the real-world setting
详细描述
Primary objective
: Comparison of prognosis between RA-ILD and RA-non ILD patients
Secondary objectives
- Identification of the prognostic factors or aggravation factors of ILD in RA-ILD patients
- Identification of the association between ILD and autoantibody profiles in RA-ILD patients
- Comparison of RA disease activity control between RA-ILD and RA-non ILD patients using disease activity score (DAS)28-erythrocyte sedimentation ratio (ESR), DAS28 C-reactive protein (CRP), simple disease activity index (SDAI) and clinical disease activity index (CDAI)
- Comparison of biologic and non-biologic DMARD treatment response in RA-ILD patients using disease activity parameters
The study population will be adult RA patients who have checked a chest computed tomography (CT) scan within 2 years of enrollment. No additional visits or laboratory tests will be done outside the routine clinical practice for RA-non ILD patients. For RA-ILD patients, high resolution computed tomography (HRCT), pulmonary function test (PFT) and 6-min walk test will be examined annually to identify the progression of ILD. Selection of medication including conventional DMARDs, biologic DMARDs, glucocorticoid, and inhaler, dosing and treatment duration are at the discretion of the investigator.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who satisfy the 1987 American college of rheumatology (ACR) or 2010 ACR/EULAR classification criteria for RA adult patients
- •Patients who are more than 19 years old
- •Patients who have checked chest CT scanning within 2 years
- •Patients who provide a written consent of participating in this study
排除标准
- •Patients who are aged under 19 years old
- •Patients who are pregnant
- •Patients who dose not provide a written consent of participating in this study
结局指标
主要结局
Mortality
时间窗: 5 years
Comparison of prognosis such as mortality between RA-ILD and RA-non ILD
次要结局
- Pulmonary function test(5 years)
- CDAI(Clinic Disease Activity Index)(5 years)
- Change of DAS28(5 years)
- DAS28(Disease Activity Score in 28 joint)(5 years)
- SDAI(Simple Disease Activity Index)(5 years)
研究者
Yoon-Kyoung Sung
Associate professor
Hanyang University