UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of the prognosis of the patients of connective tissue disease.
Acronym	Assessment of the prognosis of the patients of connective tissue disease.
Scientific Title	Assessment of the prognosis of the patients of connective tissue disease.
Scientific Title:Acronym	Assessment of the prognosis of the patients of connective tissue disease.
Region	Japan

Condition
Condition	rheumatoid arthritis, scleroderma, polymyositis-dermatomyositis, systemic lupus erythematosus, mixed connective tissue disease, Sjogren syndrome, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, microscopic polyangiitis, IgG4-related disease.
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Reveal prognostic factor of collagen disease and complications risk factors.
Basic objectives2	Others
Basic objectives -Others	Overall survival progression-free survival complications
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	progression-free survival complications

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	16 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who meet the following of one of the diagnostic criteria. 1) 2010 ACR/EULAR classification criteria for rheumatoid arthritis. 2) 2013 classification criteria for systemic sclerosis 3) Bohan and Peter criteria for polymyositis and dermatomyositis 4) 2012 SLICC classification criteria for systemic lupus erythematosus 5) 2004 Preliminary diagnostic criteria for mixed connective tissue disease proposed by Ministry of Health, Labour and Welfare in Japan. 6) 2012 ACR classification criteria for Sjogren's syndrome 7) 1990 ACR classification of Churg-Strauss syndrome (allergic granulomatosis and angiitis) 8) 1990 ACR classification of Wegener's granulomatosis (granulomatosis and angiitis) 9) 1999 diagnostic criteria for microscopic polyangiitis by Ministry of Health and Welfare in Japan. 10) 2011 Comprehensive diagnostic criteria for IgG4-related disease by Ministry of Health, Labour and Welfare in Japan.
Key exclusion criteria	1) Patients who are judged to be inappropriate as a research subject by the principal investigator or research team members. 2) Patients who are considered to be difficult to obtain a valid consent.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Kubo Middle name Last name Makoto
Organization	Yamaguchi University Hospital
Division name	Internal Medicine 2
Zip code	755-8505
Address	1-1-1,MinamiKogushi,Ube City,Yamaguchi Prefecture,Japan
TEL	0836-22-2248
Email	mkubo@yamaguchi-u.ac.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Kubo
Organization	Yamaguchi University Hospital
Division name	Internal Medicine 2
Zip code	755-8505
Address	1-1-1,MinamiKogushi,Ube City,Yamaguchi Prefecture,Japan
TEL	0836-22-2248
Homepage URL
Email	mkubo@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University Hospital
Institute
Department

Funding Source
Organization	None
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	Center For Clinical Research, Yamaguchi University Hospital
Address	1-1-1,MinamiKogushi,Ube City,Yamaguchi Prefecture,Japan
Tel	0836-22-2428
Email	me223@yamaguchi-u.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	山口大学医学部付属病院(山口県）　Yamaguchi University Hospital

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 26 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	2016 Year 07 Month 27 Day
Date of IRB	2016 Year 07 Month 27 Day
Anticipated trial start date	2016 Year 09 Month 26 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded	2022 Year 03 Month 31 Day

Other

Other related information

This study is a prospective observational study that does not involve the intervention. The subjects of the present study are collagen vascular disease patients who meet the selection criteria and are admitted to Yamaguchi University Hospital until December 2019 from September 2016. Patients are followed for five years and are evaluated a multi-factor analysis including its prognostic factor and risk factor of complications. Analysis items are such as a blood test findings, urinary findings, imaging findings, physiological laboratory findings and biopsy findings. Survival of the subject patients, exacerbation of collagen disease, complications are evaluated after five years of registration.

Management information
Registered date	2016 Year 09 Month 25 Day
Last modified on	2020 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027786