NCT04614441已完成不适用
Non-Interventional Collecting Evidences For ILD in Taiwan: Optimized Novel Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 26
- 主要终点
- Annual percentage of decline from baseline in Forced Vital Capacity (FVC, %) per cohort of IPF, SSc-ILD, or PF-ILD
研究概览
简要总结
To better understand the clinical characteristics of Idiopathic Pulmonary Fibrosis (IPF) / Systemic Sclerosis-associated-Interstitial Lung Disease (SSc-ILD)/ Progressive Fibrosing Interstitial Lung Disease (PF-ILD) patients treated with nintedanib and biomarkers associated with the disease course, a non-interventional, 3-year, prospective study will be conducted to collect the long-term real-world clinical data on IPF/SSc-ILD/PF-ILD patients newly administered with nintedanib in Taiwan
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This study plans to enroll approximately 500 patients with IPF/SSc-ILD/PF-ILD who newly initiate nintedanib per physicians' discretion within 6 months before participating in the study.
- •IPF cohort:
- •Diagnosed with IPF during the prior 6 months before study enrollment, based on the 2018 ATS/ERS/JRS/ALAT guideline
- •Patient ≥ 40 years of age
- •Newly initiating nintedanib within 6 months prior to participating in the study
- •Providing written informed consent prior to participating in the study
- •Having further follow-up possibility with participating physician during the planned study period
- •Ability to read and write in local language
- •SSc-ILD cohort:
- •Diagnosed with SSc-ILD during the prior 6 months before study enrollment, based on 2013 ACR/EULAR
- •Patient ≥ 20 years of age
- •Newly initiating nintedanib OR not receiving nintedanib per physician's discretion (For patients who diagnosed with SSc-ILD but are not treated with nintedanib on physician's discretion, they will apply the same inclusion criteria, with baseline characteristics collected only) within 6 months prior to participating in the study
- •Providing written informed consent prior to participating in the study
- •Having further follow-up possibility with participating physician during the planned study period
- •Ability to read and write in local language
- •PF-ILD cohort:
- •Diagnosed with PF-ILD (PF-ILD patients will be enrolled only after nintedanib acquires the label approval from TFDA) during the prior 6 months before study enrollment. The definition of PF-ILD diagnosis is as follows:
- •-Patients who have ILD with a progressive phenotype, but are not diagnosed with IPF, per physician's judgment. The pathophysiology in these patients is characterized by self-sustaining fibrosis and a deterioration in lung function over time, with worsening respiratory symptoms, resistance to immune-modulatory therapies, and ultimately early mortality.
- •Patient ≥ 20 years of age
- •Newly initiating nintedanib OR not receiving nintedanib per physician's discretion (For patients who diagnosed with PF-ILD but are not treated with nintedanib on physician's discretion, they will apply the same inclusion criteria, with baseline characteristics collected only) within 6 months prior to participating in the study
- •Providing written informed consent prior to participating in the study
- •Having further follow-up possibility with participating physician during the planned study period
- •Ability to read and write in local language
排除标准
- •Lung transplantation expected within the next 6 months.
- •-Included in ongoing interventional trials
研究组 & 干预措施
Idiopathic Pulmonary Fibrosis (IPF)
干预措施: OFEV® (Drug)
Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
干预措施: OFEV® (Drug)
Systemic Sclerosis-associated-Interstitial Lung Disease (SSc-ILD)
干预措施: OFEV® (Drug)
结局指标
主要结局
Annual percentage of decline from baseline in Forced Vital Capacity (FVC, %) per cohort of IPF, SSc-ILD, or PF-ILD
时间窗: Up to 5 years
IPF: Idiopathic Pulmonary Fibrosis PF-ILD: Progressive Fibrosing Interstitial Lung Disease SSc-ILD: Systemic Sclerosis-associated-Interstitial Lung Disease
Annual decline from baseline in Diffusing capacity of the Lungs for Carbon monoxide (DLco, %)
时间窗: Up to 5 years
Annual decline from baseline in resting and exercise Oxygen Saturation (SpO2, %)
时间窗: Up to 5 years
次要结局
- Time to first acute exacerbation (AE) of IPF; or time to ILD worsening for SSc-ILD/PF-ILD after study enrollment(Up to 5 years)
- Annual change from baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT)(Up to 5 years)
- Annual change from baseline in Six-Minutes Walking Test (6MWT)(Up to 5 years)
- Annual change from baseline in Berlin questionnaire(Up to 5 years)
- Annual change from baseline in St George's Respiratory Questionnaire (SGRQ) for IPF or King's Brief Interstitial Lung (K-BILD) for other ILDs(Up to 5 years)
- Mortality (with cause of death): respiratory- and non-respiratory-related death(Up to 5 years)
- Change from baseline in quantification of biomarkers(Up to 5 years)
研究者
研究点 (26)
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