UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049776 |
|---|---|
| Receipt number | R000056649 |
| Scientific Title | Role and mechanism of type I interferon in the pathogenesis of anti-MDA5 antibody-positive dermatomyositis |
| Date of disclosure of the study information | 2022/12/14 |
| Last modified on | 2024/01/04 11:13:56 |
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Basic information
Public title
Role and mechanism of type I interferon in the pathogenesis of anti-MDA5 antibody-positive dermatomyositis
Acronym
Role and mechanism of type I interferon in the pathogenesis of anti-MDA5 antibody-positive dermatomyositis
Scientific Title
Role and mechanism of type I interferon in the pathogenesis of anti-MDA5 antibody-positive dermatomyositis
Scientific Title:Acronym
Role and mechanism of type I interferon in the pathogenesis of anti-MDA5 antibody-positive dermatomyositis
Region
| Japan |
Condition
Condition
Anti-MDA5 antibody-positive dermatomyositis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
1. Analyzing the correlation between serum interferon activity and clinical manifestations, clinical course, prognosis, and treatment response in patients with anti-MDA5 antibody-positive dermatomyositis.
2. Investigating the MDA5 activation and interferon activation mechanisms induced by anti-MDA5 antibodies, and identifying the MDA5 antigen recognition sites.
3. Elucidating the inflammatory cytokine activation mechanism through the interferon-MDA5 pathway in anti-MDA5 antibody-positive dermatomyositis.
Basic objectives2
Others
Basic objectives -Others
Pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will conduct an analysis of the correlation between serum interferon activity and clinical manifestations, hematological findings, severity of interstitial lung disease (ILD), and outcomes in MDA5-DM patients. Additionally, using various clinical indicators, we will perform latent cluster analysis to establish a novel disease classification by examining the association between disease subtypes and serum interferon levels.
The measurement of interferon will be performed using the WISH IFN bioassay (Genes Immun 2007;8:492), which allows for the detection of serum interferon activity at approximately 100 times the sensitivity of conventional ELISA. Furthermore, we will use the ultra-sensitive digital ELISA method for interferon detection.
Key secondary outcomes
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Blood sampling for healthy controls
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Anti-MDA5 antibody-positive dermatomyositis group:
1) Patients diagnosed with dermatomyositis who fulfill the criteria of Bohan and Peter, or clinically amyopathic dermatomyositis who fulfill the criteria of Sontheimer.
2) Patients with positive anti-MDA5 antibody.
Connective tissue disease group:
Patients who fulfill either of the following criteria.
- 1997 American College of Rheumatology (ACR) Criteria of systemic lupus erythematosus
- ACR/European Alliance of Associations for Rheumatology (EULAR) 2010 rheumatoid arthritis classification criteria
- 2012 Revised international Chapel Hill Consensus Conference nomenclature of vasculitis
- ACR/EULAR 2013 Classification Criteria for Systemic Sclerosis
- American-European Consensus Criteria for Sjogren's Syndrome (2002)
Healthy control group:
People who do not fulfill any of the criteria of anti-MDA5 antibody-positive dermatomyositis or connective tissue disease.
Of any of the above groups, those participants who fulfill the following 1) and 2) will be included in this study.
1) The person who fully understands this study and gives his/her consent or that of his/her legal representative.
2) 18 years or older when serum was taken.
Key exclusion criteria
1) Patients or health controls who cannot give consent.
2) Patients or health controls who are unable to collect specimens.
3) Patients or health controls who are eligible to opt-out and who have requested to opt-out
4) Patients or health controls with other diseases or conditions that are considered inappropriate for this study.
5) Healthy controls with a history of connective tissue disease.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nakajima |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Allergy and Clinical Immunology
Zip code
260-8670
Address
1-8-1 Inohoana, Chuo-ku, Chiba, Chiba
TEL
043-226-2198
nakajimh@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Tomoaki |
| Middle name | |
| Last name | Ida |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Allergy and Clinical Immunology
Zip code
260-8670
Address
1-8-1 Inohoana, Chuo-ku, Chiba, Chiba
TEL
043-226-2198
Homepage URL
t.ida@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Graduate School of Medicine, Ethics Committee
Address
1-8-1 Inohoana, Chuo-ku, Chiba, Chiba
Tel
043-226-2462
inohana-rinri@chiba-u.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
千葉大学医学部附属病院（千葉県）、千葉労災病院（千葉県）、国際医療福祉大学成田病院（千葉県）、獨協医科大学病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 14 | 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
| 2022 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 14 | Day |
Last modified on
| 2024 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056649
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