UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of the pathogenic mechanism of rheumatoid arthritis by focusing on the oral microbiome
Acronym	RA-OralMB Study
Scientific Title	Analysis of the pathogenic mechanism of rheumatoid arthritis by focusing on the oral microbiome
Scientific Title:Acronym	RA-OralMB Study
Region	Japan

Condition
Condition	Rheumatoid Arthritis
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	In the two groups of ACPA-positive/negative RA, we focus on environmental factors (oral dysbiosis, periodontal disease, smoking, and HTLV-1 infection) and genetic factors (HLA-SE) that are associated with the production of ACPA to elucidate the mechanism of RA.
Basic objectives2	Others
Basic objectives -Others	To elucidate the pathogenesis of RA, we focused on 1) what environmental factors are associated with ACPA production (oral disbiosis, periodontal disease, smoking, and HTLV-1 infection) 2) what families of microbiome is represented in the oral microbiome of ACPA-positive RA patients and 3) whether ACPA maturation (i.e., elevated ACPA levels and isotype expansion) progresses in a population with HLA-DR shared epitope (SE) in addition to environmental factors.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	difference of oral microbiome composition
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
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)Rheumatoid Arthritis patients (2) Those who, after receiving a full explanation of their participation in this study, have obtained written consent of their own free will with a full understanding of the research subject.
Key exclusion criteria	(1)Those with no remaining teeth (2)Others who are deemed unsuitable as research subjects by the attending physician or principal investigator.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Kawakami
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences
Zip code	8528501
Address	1-7-1, Sakamoto,Nagasaki-shi,Nagasaki
TEL	0958197200
Email	atsushik@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Yoshika Middle name Last name Tsuji
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences
Zip code	8528501
Address	1-7-1, Sakamoto,Nagasaki-shi,Nagasaki
TEL	0958197200
Homepage URL
Email	yoshikatsuji@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University
Institute
Department

Funding Source
Organization	Nagasaki University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical research cencer, Nagasaki univrtsity
Address	1-7-1 Sakamoto
Tel	0958197200
Email	rinshou7726@umin.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

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 01 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	Preinitiation
Date of protocol fixation	2020 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date	2021 Year 01 Month 04 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is a single-center observational study.

Management information
Registered date	2020 Year 11 Month 01 Day
Last modified on	2020 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048291

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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