UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020208 |
|---|---|
| Receipt number | R000023340 |
| Scientific Title | Prospective observational study of treatment for rheumatoid arthritis-related interstitial lung disease |
| Date of disclosure of the study information | 2016/01/12 |
| Last modified on | 2022/12/20 09:02:58 |
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Basic information
Public title
Prospective observational study of treatment for rheumatoid arthritis-related interstitial lung disease
Acronym
Observational study of treatment for rheumatoid arthritis-related interstitial lung disease
Scientific Title
Prospective observational study of treatment for rheumatoid arthritis-related interstitial lung disease
Scientific Title:Acronym
Observational study of treatment for rheumatoid arthritis-related interstitial lung disease
Region
| Japan |
Condition
Condition
Rheumatoid arthritis-related interstitial lung disease
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the regimens and outcomes of treatment for rheumatoid arthritis-related interstitial lung disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in pulmonary function after 1-year treatment
Key secondary outcomes
Treatment regimens
Changes in chest CT findings, exercise torelance, and dyspnea scores after 1-year treatment
Adverse events
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. fulfilling the diagnostic criteria for rheumatoid arthritis (Arthritis Rheum 2010;62:2569-81)
2. Diagnosed as having interstitial lung disease on the basis of chest CT findings (bilateral reticulation and/or ground glass attenuation) and clinical assessment
3. Patient consent for treatment initiation
Key exclusion criteria
1. Combined case with other collagen vascular diseases
2. Pregnancy or childbearing potential
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Suda |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Hamamatsu, Shizuoka 431-3192, Japan
TEL
053-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yasunori |
| Middle name | |
| Last name | Enomoto |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Hamamatsu, Shizuoka 431-3192, Japan
TEL
053-435-2263
Homepage URL
enomotoy@hama-med.ac.jp
Sponsor or person
Institute
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board, Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Hamamatsu, Shizuoka 431-3192, Japan
Tel
053-435-2680
rinri@hama-med.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
浜松医科大学附属病院(静岡県)、聖隷三方原病院(静岡県)、聖隷浜松病院(静岡県)、遠州病院(静岡県)、天竜病院(静岡県)、浜松労災病院(静岡県)、浜松日赤病院(静岡県)、浜松医療センター(静岡県)、磐田市立病院(静岡県)、藤枝市立総合病院(静岡県)、静岡市立静岡病院(静岡県)、静岡市立清水病院(静岡県)
、静岡日赤病院、静岡県立総合病院(静岡県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 12 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: Prospective observational study
Study subjects: Patients with inclusion criteria in our collaborating institutions between January 2016 and Novemver 2020
Outcomes:
Treatment regimens; Changes in pulmonary function, chest CT findings, exercise torelance, and dyspnea scores after 1-year treatment; Adverse events
Management information
Registered date
| 2015 | Year | 12 | Month | 15 | Day |
Last modified on
| 2022 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023340
