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

Last updated: August 18, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Completed

Phase

N/A

Condition

Scar Tissue

Cystic Fibrosis

Lung Injury

Treatment

OFEV®

Clinical Study ID

NCT04614441
1199-0393
  • Ages > 20
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 plannedstudy 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 onphysician's discretion, they will apply the same inclusion criteria, with baselinecharacteristics 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 plannedstudy period

  • Ability to read and write in local language

PF-ILD cohort:

  • Diagnosed with PF-ILD (PF-ILD patients will be enrolled only after nintedanibacquires the label approval from TFDA) during the prior 6 months before studyenrollment. The definition of PF-ILD diagnosis is as follows:

--Patients who have ILD with a progressive phenotype, but are not diagnosed withIPF, per physician's judgment. The pathophysiology in these patients ischaracterized by self-sustaining fibrosis and a deterioration in lung function overtime, with worsening respiratory symptoms, resistance to immune-modulatorytherapies, 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 onphysician's discretion, they will apply the same inclusion criteria, with baselinecharacteristics 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 plannedstudy period

  • Ability to read and write in local language

Exclusion

Exclusion Criteria:

  • Lung transplantation expected within the next 6 months.

--Included in ongoing interventional trials

Study Design

Total Participants: 214
Treatment Group(s): 1
Primary Treatment: OFEV®
Phase:
Study Start date:
January 21, 2021
Estimated Completion Date:
May 14, 2025

Connect with a study center

  • Chang-Hua Christian Hospital

    Changhua, 500
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital Chiayi

    Chiayi, 613
    Taiwan

    Site Not Available

  • National Taiwan University Hospital-Hsin-Chu Branch

    Hsinchu, 300
    Taiwan

    Site Not Available

  • Buddhist Tzu Chi General Hospital

    Hualien, 970
    Taiwan

    Site Not Available

  • E-Da Hospital

    Kaohsiung, 824
    Taiwan

    Site Not Available

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung, 83301
    Taiwan

    Site Not Available

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 807
    Taiwan

    Site Not Available

  • Kaohsiung Veterans General Hospital

    Kaohsiung, 81362
    Taiwan

    Site Not Available

  • Far Eastern Memorial Hospital

    New Taipei City, 220
    Taiwan

    Site Not Available

  • Taipei Medical University-Shuang Ho Hospital

    New Taipei City, 235
    Taiwan

    Site Not Available

  • Taipei Tzu Chi General Hospital

    New Taipei City, 231
    Taiwan

    Site Not Available

  • Asia University Hospital

    Taichung, 413
    Taiwan

    Site Not Available

  • Cheng Ching Hospital

    Taichung, 407
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung, 404327
    Taiwan

    Site Not Available

  • Chung Shan Medical University Hospital

    Taichung, 40201
    Taiwan

    Site Not Available

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Site Not Available

  • Cheng Hsin Rehabilitation Medical Center

    Taipei,
    Taiwan

    Site Not Available

  • Mackay Memorial Hospital

    Taipei, 10449
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Site Not Available

  • Shin Kong Wu Ho-Su Memorial Hospital

    Taipei, 111
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

  • Tri-Service General Hospital

    Taipei, 114
    Taiwan

    Site Not Available

  • Taipei Medical University Hospital

    Taipei City, 110
    Taiwan

    Site Not Available

  • Taitung MacKay Memorial Hospital

    Taitung, 950
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital(Linkou)

    Taoyuan, 330
    Taiwan

    Site Not Available

  • TaoYuan General Hospital

    Taoyuan County,
    Taiwan

    Site Not Available

  • National Yang-Ming University Hospital

    Yilan, 26058
    Taiwan

    Site Not Available

  • National Taiwan University Hospital Yun-Lin Branch

    Yunlin County, 632
    Taiwan

    Site Not Available

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