UMIN-CTR Clinical Trial

Basic information
Public title	Prospective cohort study of rheumatoid arthritis and Sjogren's syndrome (Prevention against the development of rheumatoid arthritis, through application of musculoskeletal ultrasonography and treatment for periodontal disease, collaboration with Kanazawa, Chiba and Nagasaki University
Acronym	Early arthritis cohort against the development of rheumatoid arthritis, association with periodontal disease, collaboration with Kanazawa, Chiba and Nagasaki University,
Scientific Title	Prospective cohort study of rheumatoid arthritis and Sjogren's syndrome (Prevention against the development of rheumatoid arthritis, through application of musculoskeletal ultrasonography and treatment for periodontal disease, collaboration with Kanazawa, Chiba and Nagasaki University
Scientific Title:Acronym	Early arthritis cohort against the development of rheumatoid arthritis, association with periodontal disease, collaboration with Kanazawa, Chiba and Nagasaki University,
Region	Japan

Condition
Condition	Early arthritis
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1.To verify whether the musculoske letalultrasonography improve the outcome of early arthritis 2.To verify whether the treatment of periodontal disease improve the outcome of early arthritis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Exploratory study using blood, saliva, plaque:to examine the humoral factors and cell subsets from blood, and the humoral factors,autoantibodies and bacteria (number,types,etc)from saliva and plaque, suspected to relate with the pathogenesis of RA.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Introduce patients to the dentists to confirm the presence of periodontal disease,then the treatment is performed according to severity of periodontal disease. The information of musculoskeletal ultrasonography is provided to physician
Interventions/Control_2	Introduce patients to the dentists to confirm the presence of periodontal disease, then the treatment is performed according to severity of periodontal disease. The information of musculoskeletal ultrasonography is not provided to physician
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients provided a signed consent form to participate in the study, which is approved by the each institutional review board 2. Patients with early arthritis disease duration less than 6 months.
Key exclusion criteria	1. Under twenty years old 2. Non-RA rheumatic diseases
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mami Tamai
Organization	Nagasaki University Hospital
Division name	First department of internal medicine
Zip code
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-819-7262
Email	tamai-ngs@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Mami Tamai
Organization	Nagasaki University Hospital
Division name	First department of internal medicine
Zip code
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-819-7262
Homepage URL
Email	tamai-ngs@umin.ac.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

Funding Source
Organization	1.Preventive Medical Science, Graduate School of joint expenses 2.Grants-in-Aid for Scientific Research
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
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

Other administrative information
Date of disclosure of the study information	2014 Year 09 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	Open public recruiting
Date of protocol fixation	2014 Year 08 Month 06 Day
Date of IRB	2014 Year 07 Month 29 Day
Anticipated trial start date	2015 Year 06 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2014 Year 08 Month 18 Day
Last modified on	2021 Year 10 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017309