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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011850
Receipt No. 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

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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
Email 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
Email k.yamaji@juntendo.ac.jp

Sponsor
Institute Juntendo Universitiy,Department of Internal Medicine and Rheumatology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013850

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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