BERTHA Study: Rheumatoid Arthritis-Associated Interstitial Lung Disease: Characterization of Lung Disease Progression. A Multicenter, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Interstitial Lung Disease progression - FVC
研究概览
简要总结
BERTHA study´s primary objective is to characterize Rheumatoid Arthritis-associated Interstitial Lung Disease (RA-ILD) progression and to define a combination of biomarkers, genetic and clinical variables capable of identifying patients at risk of RA-ILD progression
详细描述
BERTHA is a multicentric, observational study that will enroll 100 RA-ILD patients to be followed for 2 years.
Interstitial Lung Disease (ILD) progression will be ascertained by quantitative image analysis and functional parameters. Variables associated with progression with be identified.
Additionally, RA-ILD endotypes will be investigated as well as their association with RA-ILD progression.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive adult patients (aged >18 years) meeting RA diagnostic criteria in accordance with ACR 2010
- •Presence of interstitial lung disease 2.1 ILD Definition: presence of interstitial alterations in HRCT associated to functional derangements and/or symptoms
- •Patient agrees with having follow-up visits every 6 months for 2 years
排除标准
- •Pregnancy or intending to become pregnant
- •Overlap with other diseases that occurs with ILD (other collagenoses, vasculitis, inflammatory bowel disease)
- •Presence of advanced ILD, characterized by:
- •a. Dyspnea rated as modified Medical Research Council 4 (mMRC4) on routine visit
- •Presence of significant Arterial Pulmonary Hypertension:
- •Evidence of Right ventricular failure evidence by echocardiography
- •Previous right chamber catheterism showing cardiac index < 2 liters/min/m²
- •Significant co-morbidity impacting respiratory system (e.g., congestive heart failure, lung neoplasm, active tuberculosis)
结局指标
主要结局
Interstitial Lung Disease progression - FVC
时间窗: 2 years
FVC longitudinal behavior (continuous variable)
次要结局
- Interstitial Lung Disease progression - death(2 years)
- Interstitial Lung Disease progression - imaging(2 years)
- Interstitial Lung Disease progression - FVC dichotomous variable(2 years)