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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: OFEV®

• Study Type: Observational
• Enrollment (Actual): 214

Contacts and Locations

Study Locations

• Taiwan
  • Changhua, Taiwan, 500
    • Chang-Hua Christian Hospital
  • Chiayi, Taiwan, 613
    • Chang Gung Memorial Hospital Chiayi
  • Hsinchu, Taiwan, 300
    • National Taiwan University Hospital-Hsin-Chu Branch
  • Kaohsiung, Taiwan, 81362
    • Kaohsiung Veterans General Hospital
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital
  • Kaohsiung, Taiwan, 824
    • E-DA Hospital
  • New Taipei City, Taiwan, 220
    • Far Eastern Memorial Hospital
  • New Taipei City, Taiwan, 235
    • Taipei Medical University-Shuang Ho Hospital
  • New Taipei City, Taiwan, 231
    • Taipei Tzu Chi General Hospital
  • Taichung, Taiwan, 404
    • China Medical University Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taichung, Taiwan, 40201
    • Chung Shan Medical University Hospital
  • Taichung, Taiwan, 407
    • Cheng Ching Hospital
  • Taichung, Taiwan, 413
    • Asia University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital
  • Taipei, Taiwan, 114
    • TRI-Service General Hospital
  • Taipei, Taiwan, 111
    • Shin Kong Wu Ho-Su Memorial Hospital
  • Taipei, Taiwan, 10016
    • National Taiwan University Hospital
  • Taipei, Taiwan
    • Cheng Hsin Rehabilitation Medical Center
  • Taipei City, Taiwan, 110
    • Taipei Medical University Hospital
  • Taitung, Taiwan, 950
    • Taitung MacKay Memorial Hospital
  • Taoyuan, Taiwan, 330
    • Chang Gung Memorial Hospital(Linkou)
  • Taoyuan County, Taiwan
    • Taoyuan General Hospital
  • Yilan, Taiwan, 26058
    • National Yang-Ming University Hospital
  • Yunlin County, Taiwan, 632
    • National Taiwan University Hospital Yun-Lin Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Idiopathic Pulmonary Fibrosis (IPF)	Drug: OFEV®; nintedanib
Progressive Fibrosing Interstitial Lung Disease (PF-ILD)	Drug: OFEV®; nintedanib
Systemic Sclerosis-associated-Interstitial Lung Disease (SSc-ILD)	Drug: OFEV®; nintedanib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2020
• Primary Completion (Estimated): July 13, 2025
• Study Completion (Estimated): July 13, 2025

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: 1199-0393

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

.

• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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'.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No