NICEFIT-ON: A Study Under Routine Clinical Practice in Taiwan to Observe the Long-term Outcome of People With Certain Types of Lung Disease (PF-ILD, SSc-ILD, IPF) Who Start Treatment With Nintedanib

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

Non-Interventional Collecting Evidences For ILD in Taiwan: Optimized Novel Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04614441
• Other study ID #: 1199-0393
• Status: Active, not recruiting
• Start date: December 25, 2020
• Est. completion date: July 13, 2025

Study information

• Verified date: July 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 214
• Est. completion date: July 13, 2025
• Est. primary completion date: July 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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:

• 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

Exclusion Criteria:

• Lung transplantation expected within the next 6 months.

--Included in ongoing interventional trials

Related Conditions & MeSH terms

• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• OFEV®
nintedanib

Locations

Country	Name	City	State
Taiwan	Chang-Hua Christian Hospital	Changhua
Taiwan	Chang Gung Memorial Hospital Chiayi	Chiayi
Taiwan	National Taiwan University Hospital-Hsin-Chu Branch	Hsinchu
Taiwan	E-Da Hospital	Kaohsiung
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	Far Eastern Memorial Hospital	New Taipei City
Taiwan	Taipei Medical University-Shuang Ho Hospital	New Taipei City
Taiwan	Taipei Tzu Chi General Hospital	New Taipei City
Taiwan	Asia University Hospital	Taichung
Taiwan	Cheng Ching Hospital	Taichung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Cheng Hsin Rehabilitation Medical Center	Taipei
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Taipei Medical University Hospital	Taipei City
Taiwan	Taitung MacKay Memorial Hospital	Taitung
Taiwan	Chang Gung Memorial Hospital(Linkou)	Taoyuan
Taiwan	TaoYuan General Hospital	Taoyuan County
Taiwan	National Yang-Ming University Hospital	Yilan
Taiwan	National Taiwan University Hospital Yun-Lin Branch	Yunlin County

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Annual decline from baseline in Diffusing capacity of the Lungs for Carbon monoxide (DLco, %)		Up to 5 years
Primary	Annual decline from baseline in resting and exercise Oxygen Saturation (SpO2, %)		Up to 5 years
Secondary	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
Secondary	Annual change from baseline in St George's Respiratory Questionnaire (SGRQ) for IPF or King's Brief Interstitial Lung (K-BILD) for other ILDs	IPF: Idiopathic Pulmonary Fibrosis ILD: Interstitial Lung Disease	Up to 5 years
Secondary	Annual change from baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT)		Up to 5 years
Secondary	Annual change from baseline in Six-Minutes Walking Test (6MWT)		Up to 5 years
Secondary	Annual change from baseline in Berlin questionnaire		Up to 5 years
Secondary	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 ß1 (TGF-ß1), Hepatocyte Growth Factor (HGF), Matrix Metalloproteinase (MMP): MMP-1, MMP-7, MMP-9, a-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-1ß, 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
Secondary	Mortality (with cause of death): respiratory- and non-respiratory-related death		Up to 5 years

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