UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024143 |
|---|---|
| Receipt number | R000027801 |
| Scientific Title | efficacy of aterosclerosis of tofacitinib in rheumatoid arthritis |
| Date of disclosure of the study information | 2016/09/23 |
| Last modified on | 2017/05/27 09:28:32 |
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Basic information
Public title
efficacy of aterosclerosis of tofacitinib in rheumatoid arthritis
Acronym
efficacy of aterosclerosis of tofacitinib in rheumatoid arthritis
Scientific Title
efficacy of aterosclerosis of tofacitinib in rheumatoid arthritis
Scientific Title:Acronym
efficacy of aterosclerosis of tofacitinib in rheumatoid arthritis
Region
| Japan |
Condition
Condition
atherosclerosis efficacy of tofacitinib in RA
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
safety and efficacy of tofacitinib in RA
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
AS values in 54 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
RA patients with moderate to severe active disease despite MTX treatment (disease activity score: DAS28>3.2)
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
RA patients with moderate to severe active disease despite MTX treatment (disease activity score: DAS28>3.2)
Key exclusion criteria
NP
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, Japan
TEL
082-232-0707
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, Japan
TEL
082-232-0707
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
| 2016 | Year | 09 | Month | 23 | 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
under submitting to journal
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 09 | Month | 23 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 23 | Day |
Last modified on
| 2017 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027801
