Clinical trial NCT04614441: 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
Official title: Non-Interventional Collecting Evidences For ILD in Taiwan: Optimized Novel Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-11-04
Enrollment: 214
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study plans to enroll approximately 500 patients with Idiopathic Pulmonary Fibrosis (IPF) / Systemic Sclerosis-associated-Interstitial Lung Disease (SSc-ILD)/ Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who newly initiate nintedanib per physicians' discretion within 6 months before participating in the study.

Brief 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 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

Exclusion Criteria:

- Lung transplantation expected within the next 6 months.

--Included in ongoing interventional trials

Primary outcomes:
measure: Annual percentage of decline from baseline in Forced Vital Capacity (FVC, %) per cohort of IPF, SSc-ILD, or PF-ILD
timeFrame: Up to 5 years
measure: Annual decline from baseline in Diffusing capacity of the Lungs for Carbon monoxide (DLco, %)
timeFrame: Up to 5 years
measure: Annual decline from baseline in resting and exercise Oxygen Saturation (SpO2, %)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Time to first acute exacerbation (AE) of IPF; or time to ILD worsening for SSc-ILD/PF-ILD after study enrollment
timeFrame: Up to 5 years
measure: Annual change from baseline in St George's Respiratory Questionnaire (SGRQ) for IPF or King's Brief Interstitial Lung (K-BILD) for other ILDs
timeFrame: Up to 5 years
measure: Annual change from baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT)
timeFrame: Up to 5 years
measure: Annual change from baseline in Six-Minutes Walking Test (6MWT)
timeFrame: Up to 5 years
measure: Annual change from baseline in Berlin questionnaire
timeFrame: Up to 5 years
measure: Change from baseline in quantification of biomarkers
timeFrame: Up to 5 years
measure: Mortality (with cause of death): respiratory- and non-respiratory-related death
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Chang-Hua Christian Hospital
city: Chiayi
country: Taiwan
facility: Chang Gung Memorial Hospital Chiayi
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital-Hsin-Chu Branch
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Kaohsiung
country: Taiwan
facility: E-Da Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Tzu Chi General Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taichung
country: Taiwan
facility: Cheng Ching Hospital
city: Taichung
country: Taiwan
facility: Asia University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taipei
country: Taiwan
facility: Cheng Hsin Rehabilitation Medical Center
city: Taitung
country: Taiwan
facility: Taitung MacKay Memorial Hospital
city: Taoyuan County
country: Taiwan
facility: TaoYuan General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital(Linkou)
city: Yilan
country: Taiwan
facility: National Yang-Ming University Hospital
city: Yunlin County
country: Taiwan
facility: National Taiwan University Hospital Yun-Lin Branch
Study officials:
References: