UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042037 |
|---|---|
| Receipt number | R000047855 |
| Scientific Title | A Clinical Study to Identify Centrally Related Factors Between the Innate Immune and Autoimmune System in SLE |
| Date of disclosure of the study information | 2020/10/07 |
| Last modified on | 2024/04/09 22:56:51 |
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Basic information
Public title
A Clinical Study to Identify Centrally Related Factors Between the Innate Immune and Autoimmune System in SLE
Acronym
A Clinical Study to Identify Centrally Related Factors Between the Innate Immune and Autoimmune System in SLE
Scientific Title
A Clinical Study to Identify Centrally Related Factors Between the Innate Immune and Autoimmune System in SLE
Scientific Title:Acronym
A Clinical Study to Identify Centrally Related Factors Between the Innate Immune and Autoimmune System in SLE
Region
| Japan |
Condition
Condition
systemic lupus erythematosus
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the mechanism leading to the autoimmune pathology of SLE via the "bridging" cytokines produced by the innate immune system by activation of the TLR7/8 signal.
Basic objectives2
Others
Basic objectives -Others
Disease activity index (SELENA SLEDAI, BILAG, PGA), SLICC Damage index, PRO (EQ-5D-5L, Lupus-PRO), Laboratory test, Blood cytokine test and Biomarker test.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Disease activity index (SELENA SLEDAI, BILAG, PGA), SLICC Damage index, PRO (EQ-5D-5L, Lupus-PRO), Laboratory test, Blood cytokine test and Biomarker test.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patient diagnosed with SLE based on the 1997 ACR Classification Criteria, or 2012 SLICC Classification Criteria, or 2019 ACR/EULAR Classification Criteria.
2. Patient aged 16 years or older at the time of informed consent with the written document.
3. Patient from whom the consent can be obtained with the written document for the participation of the study. However, for the patient aged 16 or older but under 18, consent with the written document should also be obtained from his/her legal representative.
4. Patient who received a sufficient explanation, has a will to observe, and can also observe the content of explanation provided.
Key exclusion criteria
1. Patient who has a history of receiving any of following treatments for a predetermined period prior to the baseline examination.
-Steroid pulse therapy (within 1 month)
-Oral formulation of immunosuppressants (within 3 months)
Cyclophosphamide, cyclosporine, tacrolimus, azathioprine, 6-mercaptopurine, mycophenolate mofetil, methotrexate, mizoribine
-Intravenous administration of immunosuppressants (within 6 months)
-Biological product (within 12 months)
Belimumab
-Other unapproved treatments for SLE (within 12 months)
Rituximab, study drug, etc. for SLE
-Cytapheresis (within 12 months)
2.Patient diagnosed with collagen disease other than SLE and who has experienced the therapeutic intervention (including non-drug treatment) in the past.
3.Patient who is positive in any of following viral tests at screening period or within 3 months prior to baseline (including the period prior to consent for this study).
-Human immunodeficiency virus (HIV)
-Hepatitis B surface antigen (HBs antigen)
-Hepatitis B surface antibody (HBs antibody)
However, if it is clearly due to hepatitis B vaccination, and HBs antibody alone is positive and hepatitis B virus DNA (HBV-DNA) assay is negative, participation is allowed.
-Hepatitis B virus core antibody (HBc antibody)
-Hepatitis C virus antibody (HCV antibody)
-Human T-cell leukemia virus type-1 antibody (HTLV-1 antibody)
4.Other patients considered as not appropriate for participation of the study by investigator (or subinvestigator).
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshiya |
| Middle name | |
| Last name | Tanaka |
Organization
University of Occupational and Environmental Health, Japan
Division name
The First Department of Internal Medicine, School of Medicine
Zip code
807-8555
Address
1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Japan
TEL
093-603-1611
tanaka@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Junji |
| Middle name | |
| Last name | Takahashi |
Organization
MEDISCIENCE PLANNING INC.
Division name
Clinical Development Division
Zip code
107-0052
Address
2-27-1, Shinkawa, Chuo-ku, Tokyo, Japan Tokyo Sumitomo Twin Building East
TEL
03-5544-8111
Homepage URL
junji.takahashi@mpi-cro.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Eisai Co., Ltd.
Name of secondary funder(s)
Eisai Co., Ltd.
IRB Contact (For public release)
Organization
Clinical Research Review Board, University of Occupational and Environmental Health, Japan
Address
1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Japan
Tel
093-691-1611
rinshokenkyu@mbox.clnc.uoeh-u.ac.jp
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
学校法人産業医科大学（福岡県）、国立大学法人北海道大学病院(北海道)、国立大学法人東北大学 東北大学病院(宮城県)、国立大学法人大阪大学大学院(大阪府)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 07 | 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
| 2020 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2020 | Year | 10 | Month | 07 | Day |
Last modified on
| 2024 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047855
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