UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062548 |
|---|---|
| Receipt number | R000071598 |
| Scientific Title | Circulating Interleukin-6 Levels Across Behcet's Disease and Large Vessel Vasculitis: A Systematic Review and Meta-analysis |
| Date of disclosure of the study information | 2026/08/10 |
| Last modified on | 2026/08/10 22:42:17 |
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Basic information
Public title
Circulating Interleukin-6 Levels Across Behcet's Disease and Large Vessel Vasculitis: A Systematic Review and Meta-analysis
Acronym
Circulating Interleukin-6 Levels Across Behcet's Disease and Large Vessel Vasculitis: A Systematic Review and Meta-analysis
Scientific Title
Circulating Interleukin-6 Levels Across Behcet's Disease and Large Vessel Vasculitis: A Systematic Review and Meta-analysis
Scientific Title:Acronym
Circulating Interleukin-6 Levels Across Behcet's Disease and Large Vessel Vasculitis: A Systematic Review and Meta-analysis
Region
| Japan |
Condition
Condition
Behcet's Disease
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Behcet's disease (BD) is an inflammatory disease that can involve severe organ manifestations affecting the eyes, nervous system, blood vessels, and gastrointestinal tract, potentially leading to irreversible organ damage. Circulating interleukin-6 (IL-6) levels have been reported to be associated with disease activity and severe organ involvement in BD. IL-6 is also known to play an important role in the pathogenesis of large vessel vasculitis.
This study aims to conduct a systematic review and meta-analysis of studies comparing circulating IL-6 levels between patients with BD, Takayasu arteritis, or giant cell arteritis and healthy controls, and to quantitatively evaluate the elevation of circulating IL-6 levels in each disease.
Basic objectives2
Others
Basic objectives -Others
Evaluation of circulating IL-6 levels
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in circulating IL-6 levels between patients with Behcet's disease, Takayasu arteritis, or giant cell arteritis and healthy controls.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Studies including patients with Behcet's disease (BD), Takayasu arteritis, or giant cell arteritis
2. Studies including a healthy control group
3. Studies evaluating circulating IL-6 levels in both patients and healthy controls
4. Studies providing sufficient data on circulating IL-6 levels for meta-analysis
Key exclusion criteria
1. Case reports and case series including five or fewer patients
2. Duplicate publications based on the same or overlapping study population
3. Studies published in languages other than English
4. Conference abstracts or presentations not published as full-text original articles
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Minegishi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Stem Cell and Immune Regulation
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
045-787-2630
kaoru_t@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Minegishi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Stem Cell and Immune Regulation
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
045-787-2630
Homepage URL
kaoru_t@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Graduate School of Medicine
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
Yokohama City University Graduate School of Medicine
Address
3-9, Kanazawa, Fukuura, Yokohama
Tel
045-787-2630
kaoru_t@yokohama-cu.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
| 2026 | Year | 08 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A literature search was conducted on July 16, 2026, using PubMed, the Cochrane Library, and Web of Science Core Collection. Two reviewers will independently screen all titles, abstracts, and full-text articles for eligibility. Disagreements regarding study inclusion will be resolved through discussion between the reviewers.
Participants: Patients with Behcet's disease, Takayasu arteritis, or giant cell arteritis
Intervention: Not applicable
Comparison: Healthy controls
Outcome: Circulating IL-6 levels
Management information
Registered date
| 2026 | Year | 08 | Month | 10 | Day |
Last modified on
| 2026 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071598
