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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007012
Receipt No. R000008276
Scientific Title Investigation of the pathogenesis and development of new treatments for autoimmune diseases, such as systemic lupus erythematosus
Date of disclosure of the study information 2012/02/01
Last modified on 2017/01/10

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Basic information
Public title Investigation of the pathogenesis and development of new treatments for
autoimmune diseases, such as systemic lupus erythematosus
Acronym Pathogenesis and new treatments for autoimmune diseases
Scientific Title Investigation of the pathogenesis and development of new treatments for
autoimmune diseases, such as systemic lupus erythematosus
Scientific Title:Acronym Pathogenesis and new treatments for autoimmune diseases
Region
Japan

Condition
Condition Rheumatoid arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the pathogenesis of autoimmune diseases, and to depelop new tteatment by evaluating the immune cell function, serum soluble factors in patinets with autoimmune diseases, mainly SLE
Basic objectives2 Others
Basic objectives -Others To evaluate the function of peripheral blood mononuclear cells (PBMCs) and serum soluble factors
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes TCR zeta expression on PBMC and
Serum inflammatory cytokines before immunosuppressive therapy
Key secondary outcomes Change of the above findings after immunosuppressive treatment

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Drawing peripheral blood
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
13 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria People who had informed consent to this study
Key exclusion criteria People who did not have informed consent to this study
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Koichi Amano
Organization Saitama Medical Center,
Saitama Medical University
Division name Department of Rheumatology and Clinical Immunology
Zip code
Address 1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan
TEL 049-228-3859
Email amanokoi@saitama-med.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Koichi Amano
Organization Saitama Medical Center, Saitama Medical Universitity
Division name Department of Rheumatology & Clinical Immunology
Zip code
Address 1981 Kamoda Kawagoe, Saitama 350-8550
TEL 049-228-3859
Homepage URL
Email amanokoi@saitama-med.ac.jp

Sponsor
Institute Saitama Medical Center, Saitama Medical Universitity
Institute
Department

Funding Source
Organization Saitama Medical Center, Saitama Medical Universitity
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
2012 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2012 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
2015 Year 12 Month 01 Day
Date of closure to data entry
2016 Year 02 Month 01 Day
Date trial data considered complete
2016 Year 03 Month 01 Day
Date analysis concluded
2016 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 01 Month 04 Day
Last modified on
2017 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008276

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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