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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020208
Receipt No. 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 2019/12/18

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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
Email 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
Email enomotoy@hama-med.ac.jp

Sponsor
Institute Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Institute
Department

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
Email 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 Enrolling by invitation
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
2019 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023340

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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