UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053738 |
|---|---|
| Receipt number | R000061240 |
| Scientific Title | Efficacy evaluation of Toll-like receptor (TLR) 7 inhibitor using immune cells derived from connective tissue disease patients |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2024/02/29 17:02:47 |
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Basic information
Public title
Efficacy evaluation of Toll-like receptor (TLR) 7 inhibitor using immune cells derived from connective tissue disease patients
Acronym
Efficacy evaluation of Toll-like receptor (TLR) 7 inhibitor using immune cells derived from connective tissue disease patients
Scientific Title
Efficacy evaluation of Toll-like receptor (TLR) 7 inhibitor using immune cells derived from connective tissue disease patients
Scientific Title:Acronym
Efficacy evaluation of Toll-like receptor (TLR) 7 inhibitor using immune cells derived from connective tissue disease patients
Region
| Japan |
Condition
Condition
Patients with systemic lupus erythematosus (SLE) and other connective tissue diseases
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using peripheral blood mononuclear cells, we will clarify whether small molecular compounds that selectively inhibit Toll-like receptor (TLR) 7 activation, which researchers have recently discovered, also show inhibitory effects on immune cells derived from patients with systemic lupus erythematosus (SLE) and other collagen diseases. We will also use peripheral blood mononuclear cells and serum to determine whether immune cells derived from SLE patients have greater TLR7 activation than immune cells derived from non-SLE collagen disease patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the responsiveness of peripheral blood mononuclear cells and pDCs derived from collagen disease patients to TLR7 ligand and the efficacy of bacteols compounds to inhibit it, we will evaluate the following two points: SLE patients and non-SLE collagen disease patients will be compared. Protein production: Inflammatory cytokine protein production and chemokine protein production in peripheral blood mononuclear cells and pDC culture supernatants will be measured by ELISA. Gene expression: Peripheral blood monocytes. Gene expression levels: Inflammatory cytokine gene expression, chemokine gene expression and housekeeping gene expression in peripheral blood mononuclear cells and pDC are measured by real-time PCR.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 20-65 years with systemic lupus erythematosus, rheumatoid arthritis, scleroderma, dermatomyositis/polymyositis, Behcet's disease, adult Still's disease, vasculitis syndrome, Sjogren's syndrome, and mixed connective tissue disease attending outpatient clinic of the First Department of Internal Medicine, Toyama University Hospital
Key exclusion criteria
Patients with vasculitis that makes blood sampling difficult, patients with allergies to antiseptics
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Shinoda |
Organization
Toyama University Hospital
Division name
First Department of Internal Medicine
Zip code
9300194
Address
2630 Sugitani, Toyama City
TEL
076-434-7287
koichiro@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | SHINODA |
Organization
Toyama University Hospital
Division name
First Department of Internal Medicine
Zip code
9300194
Address
2630 Sugitani, Toyama City
TEL
+81764347287
Homepage URL
koichiro@med.u-toyama.ac.jp
Sponsor or person
Institute
Toyama University
Institute
Department
Personal name
Funding Source
Organization
Toyama Prefectural University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Toyama Prefectural University
Teika Pharmaceutical Co., Ltd.
Name of secondary funder(s)
Teika Pharmaceutical Co., Ltd.
IRB Contact (For public release)
Organization
Toyama University Hospital
Address
2630 Sugitani, Toyama City
Tel
0734347287
koichiro@med.u-toyama.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.med.u-toyama.ac.jp/medicin1/kenkyu/meneki.html
Publication of results
Unpublished
Result
URL related to results and publications
http://www.med.u-toyama.ac.jp/medicin1/kenkyu/meneki.html
Number of participants that the trial has enrolled
74
Results
The results showed that miR574-stimulated TNFgene expression was induced in PBMCs of all cases, and the three compounds inhibited the expression. The inhibitory effect was stronger for HCQ, B2-24-4, and B2-24-4-5A, in that order. No significant difference in the inhibitory effect of the compounds was observed in PBMCs of SLE and RA.
Results date posted
| 2024 | Year | 02 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Number of participants: 74 (SLE: 63, non-SLE: 11)
Participant flow
Blood samples were collected from patients with rheumatoid collagen disease attending the First Department of Internal Medicine, University of Toyama Hospital, after obtaining their consent to participate in the study using a written explanation of consent at the time of their outpatient visit.
Adverse events
not particular
Outcome measures
Main results: Peripheral venous blood was obtained from SLE and RA patients, and peripheral blood mononuclear cells (PBMCs) were isolated. miR574, a micro RNA that increases in SLE patient plasma, was used to stimulate PBMCs for 18 hours. Compounds (B2-24-4-5A, B2-24-4, hydroxychloroquine (HCQ)) were added 30 minutes before miR574 stimulation, and TLR7 inhibitory activity by the compounds was evaluated by real-time PCR using TNFgene expression as an indicator.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not particular
Management information
Registered date
| 2024 | Year | 02 | Month | 29 | Day |
Last modified on
| 2024 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061240
