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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 20 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04614441
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boehringer Ingelheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Taiwan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Study Website: View Trial Website
Arms & Interventions

Arms

: Idiopathic Pulmonary Fibrosis (IPF)

: Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

: Systemic Sclerosis-associated-Interstitial Lung Disease (SSc-ILD)

Interventions

Drug: - OFEV®

nintedanib

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Chang-Hua Christian Hospital, Changhua, Taiwan

Status

Address

Chang-Hua Christian Hospital

Changhua, , 500

Chang Gung Memorial Hospital Chiayi, Chiayi, Taiwan

Status

Address

Chang Gung Memorial Hospital Chiayi

Chiayi, , 613

Hsinchu, Taiwan

Status

Address

National Taiwan University Hospital-Hsin-Chu Branch

Hsinchu, , 300

Kaohsiung, Taiwan

Status

Address

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, , 807

Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan

Status

Address

Kaohsiung Veterans General Hospital

Kaohsiung, , 81362

E-Da Hospital, Kaohsiung, Taiwan

Status

Address

E-Da Hospital

Kaohsiung, , 824

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan

Status

Address

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung, , 83301

Far Eastern Memorial Hospital, New Taipei City, Taiwan

Status

Address

Far Eastern Memorial Hospital

New Taipei City, , 220

Taipei Tzu Chi General Hospital, New Taipei City, Taiwan

Status

Address

Taipei Tzu Chi General Hospital

New Taipei City, , 231

New Taipei City, Taiwan

Status

Address

Taipei Medical University-Shuang Ho Hospital

New Taipei City, , 235

Chung Shan Medical University Hospital, Taichung, Taiwan

Status

Address

Chung Shan Medical University Hospital

Taichung, , 40201

China Medical University Hospital, Taichung, Taiwan

Status

Address

China Medical University Hospital

Taichung, , 404327

Taichung Veterans General Hospital, Taichung, Taiwan

Status

Address

Taichung Veterans General Hospital

Taichung, , 40705

Cheng Ching Hospital, Taichung, Taiwan

Status

Address

Cheng Ching Hospital

Taichung, , 407

Asia University Hospital, Taichung, Taiwan

Status

Address

Asia University Hospital

Taichung, , 413

Taipei Medical University Hospital, Taipei City, Taiwan

Status

Address

Taipei Medical University Hospital

Taipei City, , 110

National Taiwan University Hospital, Taipei, Taiwan

Status

Address

National Taiwan University Hospital

Taipei, , 100

Mackay Memorial Hospital, Taipei, Taiwan

Status

Address

Mackay Memorial Hospital

Taipei, , 10449

Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan

Status

Address

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, , 111

Taipei Veterans General Hospital, Taipei, Taiwan

Status

Address

Taipei Veterans General Hospital

Taipei, , 11217

Tri-Service General Hospital, Taipei, Taiwan

Status

Address

Tri-Service General Hospital

Taipei, , 114

Cheng Hsin Rehabilitation Medical Center, Taipei, Taiwan

Status

Address

Cheng Hsin Rehabilitation Medical Center

Taipei, ,

Taitung MacKay Memorial Hospital, Taitung, Taiwan

Status

Address

Taitung MacKay Memorial Hospital

Taitung, , 950

TaoYuan General Hospital, Taoyuan County, Taiwan

Status

Address

TaoYuan General Hospital

Taoyuan County, ,

Chang Gung Memorial Hospital(Linkou), Taoyuan, Taiwan

Status

Address

Chang Gung Memorial Hospital(Linkou)

Taoyuan, , 330

National Yang-Ming University Hospital, Yilan, Taiwan

Status

Address

National Yang-Ming University Hospital

Yilan, , 26058

Yunlin County, Taiwan

Status

Address

National Taiwan University Hospital Yun-Lin Branch

Yunlin County, , 632

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