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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
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

Full criteria on ClinicalTrials.gov

Sites (26)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chang-Hua Christian Hospital
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ChanghuaTaiwanUnknown status
Chang-Gung Memorial Hospital - Chiayi
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Chiayi CityTaiwanUnknown status
National Taiwan University Hospital Hsin Chu Branch
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HsinchuTaiwanUnknown status
Kaohsiung Chang Gung Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
E-DA Hospital
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Kaohsiung CityTaiwanUnknown status
Kaohsiung Veterans General Hospital
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Kaohsiung CityTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Taipei Tzu Chi General Hospital
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New Taipei CityTaiwanUnknown status
Taipei Medical University Shuang Ho Hospital
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New Taipei CityTaiwanUnknown status
Chung Shan Medical University Hospital
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TaichungTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
Asia University Hospital
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TaichungTaiwanUnknown status
Cheng Ching Hospital
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TaichungTaiwanUnknown status
MacKay Memorial Hospital
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TaipeiTaiwanUnknown status
Cheng Hsin Rehabilitation Medical Center
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TaipeiTaiwanUnknown status
Shin Kong Wu Ho Su Memorial Hospital
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TaipeiTaiwanUnknown status
Tri-Service General Hospital
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TaipeiTaiwanUnknown status
Taipei Medical University Hospital
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TaipeiTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
Taitung MacKay Memorial Hospital
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TaitungTaiwanUnknown status
Chang Gung Memorial Hospital, Linkou
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TaoyuanTaiwanUnknown status
TaoYuan General Hospital
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Taoyuan CountyTaiwanUnknown status
National Yang-Ming University Hospital
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YilanTaiwanUnknown status
National Taiwan University Hospital Yun-Lin Branch
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Yunlin CountyTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.