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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034665
Receipt No. R000039519
Scientific Title Analysis of the effect of periodontal infectious disease on response to biological disease-modifying antirheumatic drug in patients with rheumatoid arthritis.
Date of disclosure of the study information 2018/11/01
Last modified on 2019/04/28

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Basic information
Public title Analysis of the effect of periodontal infectious disease on response to biological disease-modifying antirheumatic drug in patients with rheumatoid arthritis.
Acronym Analysis of the effect of periodontal infectious disease on response to biological disease-modifying antirheumatic drug in patients with rheumatoid arthritis.
Scientific Title Analysis of the effect of periodontal infectious disease on response to biological disease-modifying antirheumatic drug in patients with rheumatoid arthritis.
Scientific Title:Acronym Analysis of the effect of periodontal infectious disease on response to biological disease-modifying antirheumatic drug in patients with rheumatoid arthritis.
Region
Japan

Condition
Condition Periodontal disease, Rheumatoid arthritis
Classification by specialty
Clinical immunology Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess whether periodontal infectious disease can affect response to biological disease-modifying antirheumatic drug in patients with rheumatoid arthritis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Disease activity score including 28 joints (DAS28) after 6 months of medication.
Key secondary outcomes Tender joint count (TJC), Swollen joint count (SJC), and visual analogue scale (VAS) after 6 months of medication.

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
35 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with rheumatoid arthritis and periodontal disease.
Key exclusion criteria Having less than 15 teeth, the presenc
e of pregnancy, history or the presence of any periodontal and antibiotic treatment within the previous 3 months.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Tetsuo
Middle name
Last name Kobayashi
Organization Niigata University Medical and Dental Hospital
Division name General Dentistry and Clinical Education Unit
Zip code 951-8514
Address 2-5274 Gakkocho-Dori, Chuo-ku, Niigata, 951-8514 Japan
TEL 025-227-2870
Email kotetsuo@dent.niigata-u.ac.jp

Public contact
Name of contact person
1st name Tetsuo
Middle name
Last name Kobayashi
Organization Niigata University Medical and Dental Hospital
Division name General Dentistry and Clinical Education Unit
Zip code 951-8514
Address 2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514, Japan
TEL 025-227-2870
Homepage URL
Email kotetsuo@dent.niigata-u.ac.jp

Sponsor
Institute Niigata University Medical and Dental Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Niigata University Medical and Dental Hospital
Address 2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514,
Tel 025-227-2870
Email kotetsuo@dent.niigata-u.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
2018 Year 11 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 Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 18 Day
Date of IRB
2018 Year 09 Month 27 Day
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
2021 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 retrospective study that had been performed as the analysis of the effect of cytokine targeted therapy on periodontal condition in patients with rheumatois arthritis(UMIN000013750).

Management information
Registered date
2018 Year 10 Month 26 Day
Last modified on
2019 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039519

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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