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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idiopathic Pulmonary Fibrosis (IPF) |
| ||
| Progressive Fibrosing Interstitial Lung Disease (PF-ILD) |
| ||
| Systemic Sclerosis-associated-Interstitial Lung Disease (SSc-ILD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OFEV® | Drug | nintedanib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annual percentage of decline from baseline in Forced Vital Capacity (FVC, %) per cohort of IPF, SSc-ILD, or PF-ILD | IPF: Idiopathic Pulmonary Fibrosis PF-ILD: Progressive Fibrosing Interstitial Lung Disease SSc-ILD: Systemic Sclerosis-associated-Interstitial Lung Disease | Up to 5 years |
| Annual decline from baseline in Diffusing capacity of the Lungs for Carbon monoxide (DLco, %) | Up to 5 years | |
| Annual decline from baseline in resting and exercise Oxygen Saturation (SpO2, %) | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 St George's Respiratory Questionnaire (SGRQ) for IPF or King's Brief Interstitial Lung (K-BILD) for other ILDs |
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Inclusion Criteria:
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:
SSc-ILD cohort:
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
Exclusion Criteria:
- Lung transplantation expected within the next 6 months.
--Included in ongoing interventional trials
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This study plans to enroll approximately 500 patients with Idiopathic Pulmonary Fibrosis (IPF) / Systemic Sclerosis-associated-Interstitial Lung Disease (SSc-ILD)/ Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who newly initiate nintedanib per physicians' discretion within 6 months before participating in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang-Hua Christian Hospital | Changhua | 500 | Taiwan | |||
| Chang Gung Memorial Hospital Chiayi |
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| Label | URL |
|---|---|
| Related Info | View source |
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After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
The data shared are the raw clinical study data sets.
.
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
For study documents - upon signing of a 'Document Sharing Agreement'.For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 12, 2026 | |
| Reset | Jun 5, 2026 |
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IPF: Idiopathic Pulmonary Fibrosis ILD: Interstitial Lung Disease
| 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 |
| Change from baseline in quantification of biomarkers | Biomarkers include but not limited to Platelet Derived Growth Factor (PDGF), Vascular Endothelial Growth Factor (VEGF), Fibroblast Growth Factor (FGF), Transforming Growth Factor β1 (TGF-β1), Hepatocyte Growth Factor (HGF), Matrix Metalloproteinase (MMP): MMP-1, MMP-7, MMP-9, α-defensin 1, High Mobility Group Box 1 (HMGB1), Tissue of Metalloproteinase (TIMP), Heat-Shock Protein (HSP): HSP-27, bile acid conjugated, Lysophosphatidic Acid (LPA), Lysophosphatidic Acid Receptor 1 (LPAR1), Prostagladin E2 (PGE2), Interleukin (IL): IL-1β, IL-4, IL-18, IL-13, IL-17, Monocyte Chemoattractant Protein 1 (MCP-1), Macrophage Inflammatory Protein 2 (MIP-2), periostin, osteopontin, Surfactant Protein A (SPA), Surfactant Protein D (SPD), Krebs von den Lungen 6 / Mucin 1 (KL-6/MUC1), anti-HSP70 Immunoglobolin (IgG), Bone Morphogenic Protein (BMP), Carbonhydrate Antigen-199 (CA-199), C-Reaktiv Protein degraded by MMPs (CRPM), chemokine ligand (CCL): CCL 2, CCL-18 | Up to 5 years |
| Mortality (with cause of death): respiratory- and non-respiratory-related death | Up to 5 years |
| Chiayi City |
| 613 |
| Taiwan |
| National Taiwan University Hospital-Hsin-Chu Branch | Hsinchu | 300 | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan |
| Kaohsiung Veterans General Hospital | Kaohsiung City | 81362 | Taiwan |
| E-Da Hospital | Kaohsiung City | 824 | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 83301 | Taiwan |
| Taipei Tzu Chi General Hospital | New Taipei City | 231 | Taiwan |
| Taipei Medical University-Shuang Ho Hospital | New Taipei City | 235 | Taiwan |
| Chung Shan Medical University Hospital | Taichung | 40201 | Taiwan |
| China Medical University Hospital | Taichung | 404327 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| Cheng Ching Hospital | Taichung | 407 | Taiwan |
| Asia University Hospital | Taichung | 413 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Mackay Memorial Hospital | Taipei | 10449 | Taiwan |
| Taipei Medical University Hospital | Taipei | 110 | Taiwan |
| Shin Kong Wu Ho-Su Memorial Hospital | Taipei | 111 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Tri-Service General Hospital | Taipei | 114 | Taiwan |
| Cheng Hsin Rehabilitation Medical Center | Taipei | Taiwan |
| Taitung MacKay Memorial Hospital | Taitung | 950 | Taiwan |
| Chang Gung Memorial Hospital(Linkou) | Taoyuan | 330 | Taiwan |
| TaoYuan General Hospital | Taoyuan County | Taiwan |
| National Yang-Ming University Hospital | Yilan | 26058 | Taiwan |
| National Taiwan University Hospital Yun-Lin Branch | Yunlin County | 632 | Taiwan |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 12, 2026 | Jun 5, 2026 | |||
| Jun 16, 2026 |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C530716 | nintedanib |
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