NCT04614441Completed
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
Source: ClinicalTrials.gov · Last updated 19 Aug 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 214 (actual)
- First submitted
- 29 Oct 2020
- Start date
- 21 Jan 2021
- Primary completion date
- 14 May 2025
- Lead sponsor
- Boehringer Ingelheim
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT04614441
What you commit to
- Study type: Observational
- Participants enrolled: 214
- From 21 Jan 2021 to the primary completion date, 14 May 2025
- 26 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \- Lung transplantation expected within the next 6 months.
Other
- --Included in ongoing interventional trials
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chang-Hua Christian Hospital Coordinator of this site? Confirm its status | Changhua | Taiwan | Unknown status |
| Chang-Gung Memorial Hospital - Chiayi Coordinator of this site? Confirm its status | Chiayi City | Taiwan | Unknown status |
| National Taiwan University Hospital Hsin Chu Branch Coordinator of this site? Confirm its status | Hsinchu | Taiwan | Unknown status |
| Kaohsiung Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| E-DA Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Kaohsiung Veterans General Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Taipei Tzu Chi General Hospital Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Unknown status |
| Taipei Medical University Shuang Ho Hospital Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Unknown status |
| Chung Shan Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Asia University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Cheng Ching Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| MacKay Memorial Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Cheng Hsin Rehabilitation Medical Center Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Shin Kong Wu Ho Su Memorial Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Tri-Service General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Medical University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taitung MacKay Memorial Hospital Coordinator of this site? Confirm its status | Taitung | Taiwan | Unknown status |
| Chang Gung Memorial Hospital, Linkou Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| TaoYuan General Hospital Coordinator of this site? Confirm its status | Taoyuan County | Taiwan | Unknown status |
| National Yang-Ming University Hospital Coordinator of this site? Confirm its status | Yilan | Taiwan | Unknown status |
| National Taiwan University Hospital Yun-Lin Branch Coordinator of this site? Confirm its status | Yunlin County | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.