UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031081 |
|---|---|
| Receipt number | R000035500 |
| Scientific Title | Bone structure analysis by 3T-MRI in patients with rheumatoid arthritis |
| Date of disclosure of the study information | 2018/01/31 |
| Last modified on | 2018/02/02 14:32:49 |
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Basic information
Public title
Bone structure analysis by 3T-MRI in patients with rheumatoid arthritis
Acronym
Bone structure analysis using MRI in RA
Scientific Title
Bone structure analysis by 3T-MRI in patients with rheumatoid arthritis
Scientific Title:Acronym
Bone structure analysis using MRI in RA
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the features of bone structure using MRI in patients with rheumatoid arthritis and osteoarthritis
Basic objectives2
Others
Basic objectives -Others
To investigate factors which associate bone structure parameters in patients with rheumatoid arthritis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To identify the difference in bone structure parameters between patients with rheumatoid arthritis and osteoarthritis
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients diagnosed with rheumatoid arthritis based on the American College of Rheumatology (ACR)/ EULAR 2010 criteria for the classification of RA
2.Patients diagnosed with Osteoarthritis based on the American College of Rheumatology (ACR)1986 criteria
Key exclusion criteria
1) treated with operation
2)infection
3)malignant tumor
4)other collagen disease
5)diabetes mellitus
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Suto Takahito |
Organization
Gunma University Graduate School of Medicine
Division name
Orthopaedics
Zip code
Address
3-39-22, Showamachi, Maebashisi, Gunma, Japan
TEL
027-220-8275
sdosdosdo11@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Suto Takahito |
Organization
Gunma University Graduate School of Medicine
Division name
Orthopaedics
Zip code
Address
3-39-22, Showamachi, Maebashisi, Gunma, Japan
TEL
027-220-8275
Homepage URL
sdosdosdo11@gmail.com
Sponsor or person
Institute
Department of Orthopaedic Surgery, Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Gunma University Graduate School of Medicine
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
| 2018 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing particular
Management information
Registered date
| 2018 | Year | 01 | Month | 31 | Day |
Last modified on
| 2018 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035500
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