UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter cohort study identifying prognostic factors in patients with polymyositis/dermatomyositis and interstitial lung disease
Acronym	PM/DM-ILD cohort study
Scientific Title	Multicenter cohort study identifying prognostic factors in patients with polymyositis/dermatomyositis and interstitial lung disease
Scientific Title:Acronym	PM/DM-ILD cohort study
Region	Japan

Condition
Condition	polymyositis/dermatomyositis with interstitial lung disease
Classification by specialty	Medicine in general Pneumology Clinical immunology Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify prognostic factors, including autoantibodies, imaging, and therapeutic regimens
Basic objectives2	Others
Basic objectives -Others	To evaluate regional and seasonal differences among disease subsets based on autoantibody profiles
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Survival at 3, 6, and 12 months
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
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Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Age equal or greater than 16 years 2. Clinical diagnosis of polymyositis or dermatomyositis, including clinically amyopathic dermatomyositis 3. Presence of interstitial lung disease by chest X ray or high-resolution CT scan 4. myositis-specific autoantibody identified or availability of serum samples used for identification of myositis-specific autoantibodies
Key exclusion criteria	Observation period < 6 months unless death
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masataka Kuwana
Organization	Nippon Medical School
Division name	Department of Allergy and Rheumatology
Zip code
Address	Sendagi 1-1-5, Bunkyo-ku, Tokyo, Japan
TEL	03-3822-2131
Email	kuwanam@nms.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Masataka Kuwana
Organization	Nippon Medical School
Division name	Department of Allergy and Rheumatology
Zip code
Address	Sendagi 1-1-5, Bunkyo-ku, Tokyo, Japan
TEL	03-3822-2131
Homepage URL
Email	kuwanam@nms.ac.jp

Sponsor
Institute	Anti-CADM-140 Antibody Study Group
Institute
Department

Funding Source
Organization	Astellas
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
Address
Tel
Email

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

日本医科大学（東京都）、東海大学（神奈川県）、長崎大学（長崎県）、東京女子医科大学（東京都）、自治医科大学付属さいたま医療センター（埼玉県）、防衛医科大学校（埼玉県）、横浜市立大学（神奈川県）、久留米大学（福岡県）、高知大学（高知県）、埼玉医科大学総合医療センター（埼玉県）、山口大学（山口県）、鹿児島大学（鹿児島県）、千葉大学（千葉県）、東京慈恵会医科大学（東京都）、東京慈恵会医科大学葛飾医療センター（東京都）、東邦大学医療センター大橋病院（東京都）、東邦大学医療センター大森病院（東京都）、東邦大学医療センター佐倉病院（千葉県）、藤田保健衛生大学（愛知県）、福島県立医科大学（福島県）、慶應義塾大学（東京都）、順天堂大学浦安病院（千葉県）、新潟大学（新潟県）、大分大学（大分県）、川崎市立川崎病院（神奈川県）、杏林大学（東京都）、複十字病院（東京都）、平塚共済病院（神奈川県）、山形済生病院（山形県）、東京逓信病院（東京都）、名古屋大学（愛知県）、名古屋市立大学（愛知県）、東京都立多摩総合医療センター（東京都）、北里大学（神奈川県）、岡山医療センター（岡山県）、神奈川県立循環器呼吸器病センター（神奈川県）、大阪南医療センター（大阪府）、済生会熊本病院（熊本県）、済生会新潟第2病院（新潟県）

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 24 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	Completed
Date of protocol fixation	2015 Year 05 Month 01 Day
Date of IRB	2015 Year 09 Month 01 Day
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A retrospective/prospective observational study for evaluating correlations between survivals and clinical parameters, including autoantibodies, imaging, and therapeutic regimens, using random sampling

Management information
Registered date	2015 Year 08 Month 13 Day
Last modified on	2022 Year 08 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021611