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.

  • STATUS
    Recruiting
  • End date
    Jul 13, 2025
  • participants needed
    500
  • sponsor
    Boehringer Ingelheim
Updated on 16 January 2022
nintedanib
progressive systemic sclerosis
idiopathic pulmonary fibrosis
interstitial lung disease
ofev

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

Details
Condition Idiopathic Pulmonary Fibrosis
Treatment OFEV®
Clinical Study IdentifierNCT04614441
SponsorBoehringer Ingelheim
Last Modified on16 January 2022

Eligibility

Yes No Not Sure

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
ATS/ERS/JRS/ALAT guideline
Newly initiating nintedanib within 6 months prior to participating in the study
Patient ≥ 40 years of age
Providing written informed consent prior to participating in the study
Having further follow-up possibility with participating physician during the planned
Ability to read and write in local language
study period
SSc-ILD cohort
Diagnosed with SSc-ILD during the prior 6 months before study enrollment, based on
Providing written informed consent prior to participating in the study
ACR/EULAR
Patient ≥ 20 years of age
Ability to read and write in local language
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
PF-ILD cohort
physician's discretion, they will apply the same inclusion criteria, with baseline
characteristics collected only) within 6 months prior to participating in the study
Having further follow-up possibility with participating physician during the planned
study period
Diagnosed with PF-ILD (PF-ILD patients will be enrolled only after nintedanib acquires
Providing written informed consent prior to participating in the study
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
Ability to read and write in local language
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
Having further follow-up possibility with participating physician during the planned
study period

Exclusion Criteria

Lung transplantation expected within the next 6 months
-Included in ongoing interventional trials
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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