UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058445 |
|---|---|
| Receipt number | R000066826 |
| Scientific Title | Efficacy of Interleukin-6 Inhibitors in Neuro-Behcet's Disease: A Systematic Review and Meta-Analysis |
| Date of disclosure of the study information | 2025/07/12 |
| Last modified on | 2025/07/12 21:52:54 |
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Basic information
Public title
Efficacy of Interleukin-6 Inhibitors in Neuro-Behcet's Disease: A Systematic Review and Meta-Analysis
Acronym
Efficacy of Interleukin-6 Inhibitors in Neuro-Behcet's Disease: A Systematic Review and Meta-Analysis
Scientific Title
Efficacy of Interleukin-6 Inhibitors in Neuro-Behcet's Disease: A Systematic Review and Meta-Analysis
Scientific Title:Acronym
Efficacy of Interleukin-6 Inhibitors in Neuro-Behcet's Disease: A Systematic Review and Meta-Analysis
Region
| Japan |
Condition
Condition
Neuro-Behcet's disease
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Behcet's disease is a chronic, relapsing, systemic inflammatory disorder characterized by four major clinical manifestations: oral aphthous ulcers, genital ulcers, skin lesions, and ocular involvement. While the efficacy of TNF inhibitors has been well established, their effects on neurological involvement are often insufficient. The effectiveness of interleukin-6 (IL-6) inhibitors for neuro-Behcet's disease remains unclear. This study aims to evaluate the efficacy of IL-6 inhibitors in patients with neuro-Behcet's disease through a systematic review and meta-analysis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete Remission Rate: The proportion of patients meeting all of the following criteria: Complete resolution of clinical symptoms of neuro-Behcet's disease Normalization of C-reactive protein (CRP) levels Resolution of brain lesions on MRI (disappearance of contrast-enhanced lesions) Prednisolone maintenance dose =< 0.1 mg/kg/day Absence of neurological sequelae (modified Rankin Scale <1)
Key secondary outcomes
Changes in prednisolone dosage
Improvement in inflammatory markers and disease activity
Improvement in quality of life (QOL)
Relapse rate
Adverse events (safety 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) Case reports, case series, case-control studies, cohort studies, and randomized clinical trials are eligible.
(2) Studies involving patients clinically diagnosed with neuro-Behcet's disease are eligible.
(3) Studies evaluating the efficacy and safety of IL-6 inhibitors in neuro-Behcet's disease are eligible.
Key exclusion criteria
(1) Systematic reviews or meta-analysis papers.
(2) Republished research literature will be excluded unless it contains new findings related to the efficacy or safety of IL-6 inhibitors.
(3) Research published in languages other than English.
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
| 2025 | Year | 07 | Month | 12 | 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
| 2025 | Year | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We plan to search for candidate papers using PubMed, Cochrane, EMBASE, and Web of Science Core Collection in July 2025. Hand searches will be conducted by two researchers. Each researcher will independently review all titles, abstracts, and full texts to assess eligibility. The final inclusion will be determined after resolving any discrepancies between the two researchers.
Participants: Patients with neuro-Behcet's disease
Intervention: IL-6 inhibitors
Comparison: None
Outcome: Efficacy and safety
Management information
Registered date
| 2025 | Year | 07 | Month | 12 | Day |
Last modified on
| 2025 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066826
