UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052195 |
|---|---|
| Receipt number | R000059567 |
| Scientific Title | Efficacy and safety of antifibrotic agents for interstitial lung disease associated with rheumatoid arthritis |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2024/08/05 11:54:12 |
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Basic information
Public title
Efficacy and safety of antifibrotic agents for interstitial lung disease associated with rheumatoid arthritis
Acronym
Efficacy and safety of antifibrotic agents for interstitial lung disease associated with rheumatoid arthritis
Scientific Title
Efficacy and safety of antifibrotic agents for interstitial lung disease associated with rheumatoid arthritis
Scientific Title:Acronym
Efficacy and safety of antifibrotic agents for interstitial lung disease associated with rheumatoid arthritis
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of antifibrotic agents in patients with rheumatoid arthritis-associated interstitial lung disease (RA-ILD) in a retrospective, multicenter study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To collect clinical information from patients registered in the Yokohama City University Rheumatic disease Database (Y-CURD) and patients with RA-ILD attending the Kanagawa Cardiovascular and Respiratory Disease Center.
1. Lung cancer complication rate
2. ILD relapse rate
3. Overall survival
We evaluate these outcomes with/without antifibrotic agents.
Key secondary outcomes
Base
Study type
Observational
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet the following criteria will be considered:
1. patients who meet the 2010 ACR/EULAR Classification Criteria for Rheumatoid Arthritis
2. patients with interstitial pneumonia on chest x-ray or chest CT
Key exclusion criteria
Patients who are in conflict with any of the following will not be included in this study:
1. patients complicated with collagen diseases other than RA
2. patients with a hospital history of less than 6 months
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Minegishi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Stem Cell and Immune Regulation
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
045-787-2630
kaoru_t@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Minegishi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Stem Cell and Immune Regulation
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
045-787-2630
Homepage URL
kaoru_t@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Graduate School of Medicine
Address
3-9, Kanazawa, Fukuura, Yokohama
Tel
045-787-2630
kaoru_t@yokohama-cu.ac.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
| 2023 | Year | 10 | Month | 01 | 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
13
Results
A retrospective analysis of the continuation rate and efficacy of nintedanib for ILD associated with collagen disease patients attending Yokohama City University showed that the nintedanib continuation rate after 1 year was 76.9% (10/13 patients), and no acute exacerbations of ILD were seen in patients who continued nintedanib. Due to the limited number of patients, the planned detailed analysis with lung cancer could not be performed, and the study was discontinued.
Results date posted
| 2024 | Year | 08 | Month | 05 | Day |
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
Terminated
Date of protocol fixation
| 2023 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the lung cancer complication rate, ILD relapse rate, and overall survival in RA-ILD patients and to examine fibrosis markers (KL-6, SP-D), autoantibodies (RF, anti-CCP antibodies), and anti-fibrosis drugs, and the analysis will be adjusted for confounding factors such as age, smoking, and complications.
Management information
Registered date
| 2023 | Year | 09 | Month | 13 | Day |
Last modified on
| 2024 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059567
