UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027241 |
|---|---|
| Receipt number | R000003565 |
| Scientific Title | the change of IMT of carotide artery in RA with treatment of tocilizumab |
| Date of disclosure of the study information | 2017/05/03 |
| Last modified on | 2017/05/03 20:48:42 |
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Basic information
Public title
the change of IMT of carotide artery in RA with treatment of tocilizumab
Acronym
the change of IMT of carotide artery in RA with treatment of tocilizumab
Scientific Title
the change of IMT of carotide artery in RA with treatment of tocilizumab
Scientific Title:Acronym
the change of IMT of carotide artery in RA with treatment of tocilizumab
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the efficacy of color Doppler in carotid artery with tocilizumab in RA
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
IMT
Key secondary outcomes
plaque
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
tofacitinib
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those with an active RA during the previous 12 weeks, despite prior treatment with methotrexate 12 mg per week
Key exclusion criteria
previous cardiovascular event, peripheral vascular disease, or diabetes mellitus
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kensuke kume |
Organization
hiroshima clinic
Division name
rheumatology
Zip code
Address
higashi kannon 20-16, hiroshima
TEL
0822320707
kumekensuke@live.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kensuke kume |
Organization
hiroshima clinic
Division name
rheumatology
Zip code
Address
higashi kannon 20-16, hiroshima
TEL
0822320707
Homepage URL
kumekensuke@live.jp
Sponsor or person
Institute
hiroshima clinic
Institute
Department
Personal name
Funding Source
Organization
hiroshima clinic
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
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
| 2017 | Year | 05 | Month | 03 | 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
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 03 | Day |
Last modified on
| 2017 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003565
