UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007012 |
|---|---|
| Receipt number | 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 17:36:37 |
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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
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
amanokoi@saitama-med.ac.jp
Public contact
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
amanokoi@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical Universitity
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008276
