UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013750 |
|---|---|
| Receipt number | R000016046 |
| Scientific Title | Study on effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritis |
| Date of disclosure of the study information | 2014/04/21 |
| Last modified on | 2015/04/17 09:35:29 |
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Basic information
Public title
Study on effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritis
Acronym
Study on effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritis
Scientific Title
Study on effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritis
Scientific Title:Acronym
Study on effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritis
Region
| Japan |
Condition
Condition
Rheumatoid arthritis, Periodontitis
Classification by specialty
| Clinical immunology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to evaluate clinically and biologically the effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gingival index
Bleeding on probing
Probing pocket depth
Clinical attachment level
Key secondary outcomes
Serum markers
hsCRP
IL-6
TNF-alpha
MMP-3
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
IL-6 receptor inhibition group:
Tocilizumab will be infused in 20 patients, and its effectiveness will be evaluated at 3 and 6 months later.
Interventions/Control_2
TNF inhibition group:
Infliximab, Etanercept, and Adalimumab will be infused in 20 patients, and its effectiveness will be evaluated at 3 and 6 months later.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Individuals whose consents are obtained in written form on participation in the present study.
2. Individuals with rheumatoid arthritis who have a minimum of 20 teeth.
Key exclusion criteria
1.Individuals who had received scaling and root planing within the previous 3 months before the study starts.
2.Individuals who had taken systemic antibiotics or anti-inflammatory drugs within 3 months before the study starts.
3.Individuals with severe systemic diseases
4.Individuals who are or suspected to be pregnant.
5.Individuals who are considered not eligible for the present study due to any reasons by the investigators.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromasa Yoshie |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Periodontology
Zip code
Address
2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514, Japan
TEL
025-227-2869
yoshie@dent.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuo Kobayashi |
Organization
Niigata University Medical and Dental Hospital
Division name
General Dentistry and Clinical Education Unit
Zip code
Address
2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514, Japan
TEL
025-227-2870
Homepage URL
kotetsuo@dent.niigata-u.ac.jp
Sponsor or person
Institute
Division of Periodontology, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
新潟大学大学院医歯学総合研究科（新潟県）、新潟県立リウマチセンター（新潟県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 21 | 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
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 17 | Day |
Last modified on
| 2015 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016046
