UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019215 |
|---|---|
| Receipt number | R000022061 |
| Scientific Title | The research for immunological alteration in the pathogenesis of chronic inflammatory skin diseases including psoriasis, atopic dermatitis, SLE. |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2016/02/12 15:36:45 |
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Basic information
Public title
The research for immunological alteration in the pathogenesis of chronic inflammatory skin diseases including psoriasis, atopic dermatitis, SLE.
Acronym
The immunological alteration in the chronic inflammatory skin diseases
Scientific Title
The research for immunological alteration in the pathogenesis of chronic inflammatory skin diseases including psoriasis, atopic dermatitis, SLE.
Scientific Title:Acronym
The immunological alteration in the chronic inflammatory skin diseases
Region
| Japan |
Condition
Condition
chronic inflammatory skin diseases including psoriasis, atopic dermatitis, SLE
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The pathogenesis of psoriasis is associated with IL-23/Th 17 axis. However, there are a lot of unknown phenomena in the development of psoriasis. Therefore, we investigate the immunological alterations using samples taken from patients with psoriasis. We also examine the immunological changes in atopic dermatitis and SLE.
Basic objectives2
Others
Basic objectives -Others
The evaluation circulating Th 17 cells after the treatment with anti-TNF-a blockers.
The assessment immunological changes in samples of skin blood taken from patients with psoriasis
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
TNF blocker inhibitors down-regulate at least two distinct pathways to attenuate IL-17 signalling in psoriasis: a direct effect on Th17 cells and an indirect effect via other types of cells, such as TipDCs.
Key secondary outcomes
Anti-TNFa antibody didn't affect Th1 pathway.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with psoriasis, atopic dermatitis, SLE
Key exclusion criteria
Patients with other inflammatory skin diseases
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimiko Nakajima |
Organization
Kochi Medical School, Kochi University
Division name
Department of Dermatology
Zip code
Address
185-1 Kohasu, Okohcho, Nankoku, Kochi
TEL
088-880-2363
nakajimk@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimiko Nakajima |
Organization
Kochi Medical School, Kochi University
Division name
Department of Dermatology
Zip code
Address
185-1 Kohasu, Okohcho, Nankoku, Kochi
TEL
088-880-2363
Homepage URL
nakajimk@kochi-u.ac.jp
Sponsor or person
Institute
Department of Dermatology, Kochi Medical School, Kochi University
Institute
Department
Personal name
Funding Source
Organization
Department of Dermatology, Kochi Medical School, Kochi University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
高知大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 01 | 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
TNF inhibitors directly target Th17 cells via attenuation of autonomous TNF/TNFR2 signalling in psoriasis. In vitro Th17-polarized cells from PBMC produced TNF-a in FACS analysis. In addition, TH17-polarized cells exhibited inceased expression of TNFR2. FACS and ELISA confirmed the reduction of IL-17A proteins levels by THF inhibitor. The treatment with anti-TNFR2 significantly down-regulated the production of IL-17A from Th17 cells from psoriasis patients as well as treatment with TNF inhibitor.
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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 30 | Day |
Other
Other related information
We will assess the immunological abnormal findings in patients with psoriasis who visit the Department of Dermatology, Kochi Medical School.
Management information
Registered date
| 2015 | Year | 10 | Month | 02 | Day |
Last modified on
| 2016 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022061
