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

Boehringer Ingelheim

Status

Active, not recruiting

Conditions

Idiopathic Pulmonary Fibrosis

Treatments

Drug: OFEV®

Study type

Observational

Funder types

Industry

Identifiers

NCT04614441

1199-0393

Details and patient eligibility

About

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

Enrollment

214 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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 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