UMIN-CTR Clinical Trial

Basic information
Public title	Prognostic factors for patients with anti-melanoma differentiation-associated gene 5 (MDA-5) antibody positive idiopathic inflammatory myopathy (IIM) associated interstitial lung disease (ILD): a single centor retrospective cohort study
Acronym	Not applicable
Scientific Title	Prognostic factors for patients with anti-melanoma differentiation-associated gene 5 (MDA-5) antibody positive idiopathic inflammatory myopathy (IIM) associated interstitial lung disease (ILD): a single centor retrospective cohort study
Scientific Title:Acronym	Not applicable
Region	Japan

Condition
Condition	anti-MDA-5 antibody-positive patients with IIM associated ILD
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to explore the prognostic factors limited to patients with anti-MDA-5 antibody positive IIM associated ILD.
Basic objectives2	Others
Basic objectives -Others	Mortality at 3months, 6 months, 12 months, and 24 months
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Mortality at 12 months
Key secondary outcomes	Mortality at 3months, 6 months, and 24 months

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	MDA-5 antibody positive IIM associated ILD
Key exclusion criteria	Not applicable
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Ryo Middle name Last name Yanai
Organization	Showa University
Division name	Division of Rheumatology, Department of Medicine
Zip code	142-8666
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL	+81-3-3784-8942
Email	ryo.yanai@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Ryo Middle name Last name Yanai
Organization	Showa University
Division name	Division of Rheumatology, Department of Medicine
Zip code	142-8666
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL	+81-3-3784-8942
Homepage URL
Email	ryo.yanai@med.showa-u.ac.jp

Sponsor
Institute	Showa University Division of Rheumatology, Department of Medicine
Institute
Department

Funding Source
Organization	Not applicable
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Not applicable
Name of secondary funder(s)	Not applicable

IRB Contact (For public release)
Organization	Not applicable
Address	Not applicable
Tel	Not applicable
Email	Not applicable

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	昭和大学病院（東京都）Showa University Hospital

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 16 Day

Related information
URL releasing protocol	Not applicable
Publication of results	Unpublished

Result
URL related to results and publications	Not applicable
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	2010 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date	2010 Year 01 Month 02 Day
Last follow-up date	2020 Year 12 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Not applicable

Management information
Registered date	2020 Year 12 Month 11 Day
Last modified on	2020 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048779