UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030671 |
|---|---|
| Receipt number | R000035018 |
| Scientific Title | Study on the validity of rheumatoid arthritis lesion evaluation by SMI joint echo |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2023/07/10 15:46:47 |
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Basic information
Public title
Study on the validity of rheumatoid arthritis lesion evaluation by SMI joint echo
Acronym
Validity evaluation test of SMI joint echo
Scientific Title
Study on the validity of rheumatoid arthritis lesion evaluation by SMI joint echo
Scientific Title:Acronym
Validity evaluation test of SMI joint echo
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the validity of arthritis evaluation by SMI joint echo
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between SMI method, MRI and clinical score of rheumatoid arthritis, compared with Power Doppler method
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients satisfying the diagnostic criteria of rheumatoid arthritis
Key exclusion criteria
Cases participating in other clinical studies
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Mori |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
0227177245
yu-mori@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Mori |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Orthopeadic Surgery
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
0227177245
Homepage URL
yu-mori@med.tohoku.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Tohoku University Hospital
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
Tel
0227284105
ec@rinri.hosp.tohoku.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 | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.med.tohoku.ac.jp/public/doc/
Publication of results
Unpublished
Result
URL related to results and publications
https://www.med.tohoku.ac.jp/public/doc/
Number of participants that the trial has enrolled
30
Results
Analysis continues on arthritis assessment by SMI and power Doppler.
Results date posted
| 2022 | Year | 07 | Month | 09 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Delayed analysis
Date of the first journal publication of results
Baseline Characteristics
Before treatment of rheumatoid arthritis or before treatment change after arthritis exacerbation due to secondary invalidity
Participant flow
Joint ultrasonography in cases of rheumatoid arthritis before treatment for rheumatoid arthritis or before changing treatment after arthritis exacerbation due to secondary invalidity.
Adverse events
None
Outcome measures
Quantitative Evaluation of Synovitis by Ultrasonography
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
described above
Management information
Registered date
| 2018 | Year | 01 | Month | 04 | Day |
Last modified on
| 2023 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035018
| 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 |
