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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014886
Receipt No. R000017309
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
Date of disclosure of the study information 2014/09/01
Last modified on 2016/07/05

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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 Preinitiation
Date of protocol fixation
2014 Year 08 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 08 Month 18 Day
Last modified on
2016 Year 07 Month 05 Day


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

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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