UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014886
Receipt number 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 2021/10/22 11:11:39

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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 or person

Institute

Nagasaki University Hospital

Institute

Department

Personal name



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

Value
https://center6.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