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
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| ClinicalTrials.gov Identifier: NCT04614441 |
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Recruitment Status :
Active, not recruiting
First Posted : November 4, 2020
Last Update Posted : March 8, 2023
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| Condition or disease | Intervention/treatment |
|---|---|
| Idiopathic Pulmonary Fibrosis | Drug: OFEV® |
| Study Type : | Observational |
| Actual Enrollment : | 214 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Non-Interventional Collecting Evidences For ILD in Taiwan: Optimized Novel Therapy |
| Actual Study Start Date : | December 25, 2020 |
| Estimated Primary Completion Date : | July 13, 2025 |
| Estimated Study Completion Date : | July 13, 2025 |
| 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 |
- Annual percentage of decline from baseline in Forced Vital Capacity (FVC, %) per cohort of IPF, SSc-ILD, or PF-ILD [ Time Frame: 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, %) [ Time Frame: Up to 5 years ]
- Annual decline from baseline in resting and exercise Oxygen Saturation (SpO2, %) [ Time Frame: Up to 5 years ]
- Time to first acute exacerbation (AE) of IPF; or time to ILD worsening for SSc-ILD/PF-ILD after study enrollment [ Time Frame: 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 [ Time Frame: Up to 5 years ]IPF: Idiopathic Pulmonary Fibrosis ILD: Interstitial Lung Disease
- Annual change from baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) [ Time Frame: Up to 5 years ]
- Annual change from baseline in Six-Minutes Walking Test (6MWT) [ Time Frame: Up to 5 years ]
- Annual change from baseline in Berlin questionnaire [ Time Frame: Up to 5 years ]
- Change from baseline in quantification of biomarkers [ Time Frame: Up to 5 years ]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
- Mortality (with cause of death): respiratory- and non-respiratory-related death [ Time Frame: Up to 5 years ]
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| Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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:
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04614441
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| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT04614441 |
| Other Study ID Numbers: |
1199-0393 |
| First Posted: | November 4, 2020 Key Record Dates |
| Last Update Posted: | March 8, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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. . |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
| 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. |
| 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'. |
| URL: | https://www.mystudywindow.com/msw/datasharing |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Lung Diseases Respiratory Tract Diseases |