UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053213 |
|---|---|
| Receipt number | R000060719 |
| Scientific Title | Patient characteristics and treatment patterns of antifibrotics in patients with fibrosing interstitial lung diseases initiating antifibrotics in Japanese clinical practice: Real world results from a Japanese administrative database in Japan |
| Date of disclosure of the study information | 2024/01/31 |
| Last modified on | 2024/01/09 10:30:40 |
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Basic information
Public title
Patient characteristics and treatment patterns of antifibrotics in antifibrotics-treated fibrosing interstitial lung disease patients in Japan
Acronym
Patient characteristics and treatment patterns of antifibrotics in antifibrotics-treated fibrosing interstitial lung disease patients in Japan
Scientific Title
Patient characteristics and treatment patterns of antifibrotics in patients with fibrosing interstitial lung diseases initiating antifibrotics in Japanese clinical practice: Real world results from a Japanese administrative database in Japan
Scientific Title:Acronym
Patient characteristics and treatment patterns of antifibrotics in patients with fibrosing interstitial lung diseases initiating antifibrotics in Japanese clinical practice: Real world results from a Japanese administrative database in Japan
Region
| Japan |
Condition
Condition
Fibrosing interstitial lung disease (ILD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify patient characteristics and treatment patterns of patients of antifibrotics in antifibrotics-treated patients with fibrosing ILDs in Japanese clinical practice.
Basic objectives2
Others
Basic objectives -Others
Actual use conditions
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
･Baseline characteristics of patients with idiopathic pulmonary fibrosis (IPF), Systemic sclerosis-interstitial lung disease (SSc-ILD) and progressive fibrosing interstitial lung diseases (PF-ILDs) other than IPF; treated with antifibrotics or oral and intravenous injectable corticosteroids/immunosuppressive drugs/anti-connective tissue disease (CTD) drugs for ILD treatment
･The number and classes of drugs for ILD treatment concomitant with antifibrotics at the time of initiation of antifibrotic treatment in patients with IPF, SSc-ILD and PF-ILDs other than IPF treated with antifibrotics
･The number and classes of drugs for ILD treatment prior to initiation of antifibrotics in patients with IPF, SSc-ILD and PF-ILDs other than IPF treated with antifibrotics
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
･Nintedanib/pirfenidone users in patients with IPF
1) Patients prescribed pirfenidone or nintedanib
2) Patients for whom data can be extracted for at least 6 months prior to the index date as baseline data and for at least 2 months after the index date as follow-up period
3) Patients with IPF disease codes within 6 months before or on the index date
4) Patients aged 20 years and older on the index date
･Nintedanib users and users of oral and intravenous injectable corticosteroids/immunosuppressive drugs/anti-CTD drugs for ILD treatment in patients with SSc-ILD
1) Patients prescribed nintedanib or oral and intravenous injectable corticosteroids/immunosuppressive drugs/anti-CTD drugs for ILD treatment
2) Patients for whom data can be extracted for at least 6 months prior to the index date as baseline data and for at least 2 months after the index date as follow-up period
3) Patients with SSc-ILD disease codes or ICD-10/disease codes for both fibrosing ILD and SSc within 6 months before or on the index date
4) Patients aged 20 years and older on the index date
･Nintedanib users and users of oral and intravenous injectable corticosteroids/immunosuppressive drugs/anti-CTD drugs for ILD treatment in patients with PF-ILD other than IPF
1) Patients prescribed nintedanib or oral and intravenous injectable corticosteroids/immunosuppressive drugs/anti-CTD drugs for ILD treatment
2) Patients for whom data can be extracted for at least 6 months prior to the index date as baseline data and for at least 2 months after the index date as follow-up period
3) Patients with fibrosing ILD ICD-10/disease codes within 6 months before or on the index date
4) Patients aged 20 years and older on the index date
Key exclusion criteria
･Nintedanib/pirfenidone users in patients with IPF
1) Patients prescribed pirfenidone before 31-Aug-2015
2) Patients with fibrosing ILD disease codes other than IPF and/or any underlying disease code within 6 months before or on the index date
･Nintedanib users and users of oral and intravenous injectable corticosteroids/immunosuppressive drugs/anti-CTD drugs for ILD treatment in patients with SSc-ILD
1) Patients prescribed oral and intravenous injectable corticosteroids/immunosuppressive drugs/anti-CTD drugs for ILD treatment before 20 Dec 2019
･Nintedanib users and users of oral and intravenous injectable corticosteroids/immunosuppressive drugs/anti-CTD drugs for ILD treatment in patients with PF-ILD other than IPF
1) Patients with only IPF disease codes without any fibrosing-ILD codes other than IPF and/or any underlying disease codes within 6 months before or on the index date
2) Patients prescribed oral and intravenous injectable corticosteroids/immunosuppressive drugs/anti-CTD drugs for ILD treatment before 29 May 2020
Target sample size
41000000
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ito |
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Division name
Medical Affairs
Zip code
141-6017
Address
2-1-1 Osaki, Shinagawa-ku, Tokyo, Japan
TEL
03-6417-2200
tomohiro.ito@boehringer-ingelheim.com
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ito |
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Division name
Medical Affairs
Zip code
141-6017
Address
2-1-1 Osaki, Shinagawa-ku, Tokyo, Japan
TEL
03-6417-2200
Homepage URL
tomohiro.ito@boehringer-ingelheim.com
Sponsor or person
Institute
Nippon Boehringer Ingelheim Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takahashi Clinic Ethics Committee
Address
Medicalhat 1F, 5-1-31, kitamachi, iwaya, nada-ku, kobe-shi, Hyogo
Tel
078-882-6432
kishimoto.satoshi@neues.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational and non-interventional study using an existing database, the MDV database.The data is anonymized and no identifiable personal information is included in the database. Therefore, this study does not require informed consent from the patients.
Management information
Registered date
| 2023 | Year | 12 | Month | 25 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060719
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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