UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027672 |
|---|---|
| Receipt number | R000031696 |
| Scientific Title | immunity and inflammation related to osteoarthrosis and rheumatoid arthritis |
| Date of disclosure of the study information | 2018/03/31 |
| Last modified on | 2019/12/09 18:13:08 |
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Basic information
Public title
immunity and inflammation related to osteoarthrosis and rheumatoid arthritis
Acronym
immunity and inflammation related to osteoarthrosis and rheumatoid arthritis
Scientific Title
immunity and inflammation related to osteoarthrosis and rheumatoid arthritis
Scientific Title:Acronym
immunity and inflammation related to osteoarthrosis and rheumatoid arthritis
Region
| Japan |
Condition
Condition
osteoarthrosis and rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to know the mechanism of chronic inframmation and immunity
Basic objectives2
Others
Basic objectives -Others
no
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
immunity cells
Key secondary outcomes
immunity cells
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
OA
Kellgren-Lawrence more than grade2
RA
ACR/EULAR2010 more than 6/10
more than 20 years old
Key exclusion criteria
cancer patient
another connective tissue disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromichi Tsuchiya |
Organization
Showa University School of Medicine
Division name
Medical education
Zip code
Address
1-5-8 Hatanodai Shinagawa Tokyo
TEL
03-3784-8125
hiromichi@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromichi Tsuchiya |
Organization
Showa University School of Medicine
Division name
Medical education
Zip code
Address
1-5-8 Hatanodai Shinagawa Tokyo
TEL
03-3784-8125
Homepage URL
hiromichi@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Showa University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
昭和大学医学部
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 31 | 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
| 2017 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 07 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 09 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 09 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 09 | Day |
Other
Other related information
no result
Management information
Registered date
| 2017 | Year | 06 | Month | 07 | Day |
Last modified on
| 2019 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031696
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
