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
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
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
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
