UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the pathogenesis and development of new treatments for autoimmune diseases, such as systemic lupus erythematosus
Title of the study (Brief title)	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
Name of lead principal investigator	Koichi Amano
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Rheumatology and Clinical Immunology
Address	1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan
TEL	049-228-3859
Email	amanokoi@saitama-med.ac.jp

Public contact
Name of contact person	Koichi Amano
Organization	Saitama Medical Center, Saitama Medical Universitity
Division name	Department of Rheumatology & Clinical Immunology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000008276