UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011850 |
|---|---|
| Receipt number | R000013850 |
| Scientific Title | Search of the pathogenicity factor in peripheral blood and its removing method in a rheumatic disease. |
| Date of disclosure of the study information | 2013/12/01 |
| Last modified on | 2014/09/25 15:05:45 |
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Basic information
Public title
Search of the pathogenicity factor in peripheral blood and its removing method in a rheumatic disease.
Acronym
Search of the pathogenicity factor in peripheral blood and its removing method in a rheumatic disease.
Scientific Title
Search of the pathogenicity factor in peripheral blood and its removing method in a rheumatic disease.
Scientific Title:Acronym
Search of the pathogenicity factor in peripheral blood and its removing method in a rheumatic disease.
Region
| Japan |
Condition
Condition
Rheumatic disease(ex Systemic Lupus Erythematosus, rheumatoid arthritis).
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Apheresis is a safe and effective method even in an intractable rheumatic disease(ex Systemic Lupus Erythematosus, Rheumatoid arthritis).
The aims of this study are to analyze proteins distributions which trapped in an adsorption column and to inspect removal method for a pathogenic factor.
This study may find out an improved apheresis devices which fit more intractable disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Peripheral blood cytokine levels before and after apheresis procedures.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Over 20 years Rheuatic disease patients who treated with an usual apheresis therapy at Juntendo university hospital, Tokyo, Japan.
Key exclusion criteria
Patients who reject to entry this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Yamaji |
Organization
Juntendo Universitiy
Division name
Department of Internal Medicine and Rheumatology
Zip code
Address
3-1-3 Hongo, Bunkyo, Tokyo, Japan
TEL
03-3813-3111
k.yamaji@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makio Kusaoi |
Organization
Juntendo Universitiy
Division name
Department of Internal Medicine and Rheumatology
Zip code
Address
3-1-3 Hongo, Bunkyo, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
k.yamaji@juntendo.ac.jp
Sponsor or person
Institute
Juntendo Universitiy,Department of Internal Medicine and Rheumatology
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2013 | Year | 12 | Month | 01 | 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
| 2013 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | 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
retrospective study
Management information
Registered date
| 2013 | Year | 09 | Month | 24 | Day |
Last modified on
| 2014 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013850
| Research Plan | |
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