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
- Registration Number
- NCT04614441
- Lead Sponsor
- Boehringer Ingelheim
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 214
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
- Lung transplantation expected within the next 6 months.
--Included in ongoing interventional trials
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Progressive Fibrosing Interstitial Lung Disease (PF-ILD) OFEV® - Systemic Sclerosis-associated-Interstitial Lung Disease (SSc-ILD) OFEV® - Idiopathic Pulmonary Fibrosis (IPF) OFEV® -
- Primary Outcome Measures
Name Time Method Annual decline from baseline in resting and exercise Oxygen Saturation (SpO2, %) Up to 5 years Annual percentage of decline from baseline in Forced Vital Capacity (FVC, %) per cohort of IPF, SSc-ILD, or PF-ILD Up to 5 years IPF: Idiopathic Pulmonary Fibrosis PF-ILD: Progressive Fibrosing Interstitial Lung Disease SSc-ILD: Systemic Sclerosis-associated-Interstitial Lung Disease
Annual decline from baseline in Diffusing capacity of the Lungs for Carbon monoxide (DLco, %) Up to 5 years
- Secondary Outcome Measures
Name Time Method Annual change from baseline in Berlin questionnaire Up to 5 years Time to first acute exacerbation (AE) of IPF; or time to ILD worsening for SSc-ILD/PF-ILD after study enrollment Up to 5 years Annual change from baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Up to 5 years Annual change from baseline in Six-Minutes Walking Test (6MWT) Up to 5 years Annual change from baseline in St George's Respiratory Questionnaire (SGRQ) for IPF or King's Brief Interstitial Lung (K-BILD) for other ILDs Up to 5 years IPF: Idiopathic Pulmonary Fibrosis ILD: Interstitial Lung Disease
Mortality (with cause of death): respiratory- and non-respiratory-related death Up to 5 years Change from baseline in quantification of biomarkers Up to 5 years Biomarkers include but not limited to Platelet Derived Growth Factor (PDGF), Vascular Endothelial Growth Factor (VEGF), Fibroblast Growth Factor (FGF), Transforming Growth Factor β1 (TGF-β1), Hepatocyte Growth Factor (HGF), Matrix Metalloproteinase (MMP): MMP-1, MMP-7, MMP-9, α-defensin 1, High Mobility Group Box 1 (HMGB1), Tissue of Metalloproteinase (TIMP), Heat-Shock Protein (HSP): HSP-27, bile acid conjugated, Lysophosphatidic Acid (LPA), Lysophosphatidic Acid Receptor 1 (LPAR1), Prostagladin E2 (PGE2), Interleukin (IL): IL-1β, IL-4, IL-18, IL-13, IL-17, Monocyte Chemoattractant Protein 1 (MCP-1), Macrophage Inflammatory Protein 2 (MIP-2), periostin, osteopontin, Surfactant Protein A (SPA), Surfactant Protein D (SPD), Krebs von den Lungen 6 / Mucin 1 (KL-6/MUC1), anti-HSP70 Immunoglobolin (IgG), Bone Morphogenic Protein (BMP), Carbonhydrate Antigen-199 (CA-199), C-Reaktiv Protein degraded by MMPs (CRPM), chemokine ligand (CCL): CCL 2, CCL-18
Trial Locations
- Locations (27)
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
E-Da Hospital
🇨🇳Kaohsiung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
National Yang-Ming University Hospital
🇨🇳Yilan, Taiwan
Chang-Hua Christian Hospital
🇨🇳Changhua, Taiwan
Chang Gung Memorial Hospital Chiayi
🇨🇳Chiayi, Taiwan
National Taiwan University Hospital-Hsin-Chu Branch
🇨🇳Hsinchu, Taiwan
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
Far Eastern Memorial Hospital
🇨🇳New Taipei City, Taiwan
Taipei Tzu Chi General Hospital
🇨🇳New Taipei City, Taiwan
Cheng Ching Hospital
🇨🇳Taichung, Taiwan
Taipei Medical University Hospital
🇨🇳Taipei City, Taiwan
TaoYuan General Hospital
🇨🇳Taoyuan County, Taiwan
National Taiwan University Hospital Yun-Lin Branch
🇨🇳Yunlin County, Taiwan
Cheng Hsin Rehabilitation Medical Center
🇨🇳Taipei, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan
Taipei Medical University-Shuang Ho Hospital
🇨🇳New Taipei City, Taiwan
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
🇨🇳Taipei, Taiwan
Asia University Hospital
🇨🇳Taichung, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Taitung MacKay Memorial Hospital
🇨🇳Taitung, Taiwan
Chang Gung Memorial Hospital(Linkou)
🇨🇳Taoyuan, Taiwan
Mackay Memorial Hospital
🇨🇳Taipei, Taiwan