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
1 other identifier
observational
214
1 country
26
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
Longer than P75 for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2020
CompletedFirst Posted
Study publicly available on registry
November 4, 2020
CompletedStudy Start
First participant enrolled
January 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2025
CompletedAugust 19, 2025
August 1, 2025
4.3 years
October 29, 2020
August 18, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (7)
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
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
- +2 more secondary outcomes
Study Arms (3)
Idiopathic Pulmonary Fibrosis (IPF)
Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Systemic Sclerosis-associated-Interstitial Lung Disease (SSc-ILD)
Interventions
nintedanib
Eligibility Criteria
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.
You may qualify if:
- 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
- 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:
- +6 more criteria
You may not qualify if:
- \- Lung transplantation expected within the next 6 months.
- Included in ongoing interventional trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Chang-Hua Christian Hospital
Changhua, 500, Taiwan
Chang Gung Memorial Hospital Chiayi
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
TaoYuan General Hospital
Taoyuan, Taiwan
Chang Gung Memorial Hospital(Linkou)
Taoyuan District, 330, Taiwan
National Yang-Ming University Hospital
Yilan, 26058, Taiwan
National Taiwan University Hospital Yun-Lin Branch
Yunlin County, 632, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2020
First Posted
November 4, 2020
Study Start
January 21, 2021
Primary Completion
May 14, 2025
Study Completion
May 14, 2025
Last Updated
August 19, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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'.
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. .