UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049243 |
|---|---|
| Receipt number | R000056084 |
| Scientific Title | The incidence of macrophage activation syndrome in patients with adult-onset Still's disease receiving biological therapy |
| Date of disclosure of the study information | 2022/10/17 |
| Last modified on | 2023/07/18 23:35:55 |
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Basic information
Public title
The incidence of macrophage activation syndrome in patients with adult-onset Still's disease receiving biological therapy
Acronym
The incidence of macrophage activation syndrome in patients with adult-onset Still's disease receiving biological therapy
Scientific Title
The incidence of macrophage activation syndrome in patients with adult-onset Still's disease receiving biological therapy
Scientific Title:Acronym
The incidence of macrophage activation syndrome in patients with adult-onset Still's disease receiving biological therapy
Region
| Japan |
Condition
Condition
Adult-onset Still's disease
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Adult-onset Still's disease (AOSD) is a rare systemic inflammatory disease, and treated with NASIDs, corticosteroids, and immunosuppressant. But for refractory cases, biologics are used. AOSD is often complicated by macrophage activation syndrome (MAS), even under biologics. However, it is unknown whether the type of biologics affects the incidence of MAS. Therefore, we will conduct a systematic review and meta-analysis to examine the incidence of MAS based on different type of biologics.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome: The prevalence of MAS will be pooled using random effects model meta-analysis.
Key secondary outcomes
Secondary outcome: The frequency of serious adverse events will be pooled using random effects model meta-analysis.
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)The published study including case-control study, cohort study, and randomized clinical trial.
(2)The patients are clinically diagnosed with AOSD.
(3)The experimental group of the study is treated by biologics, with or without control treatment arm.
(5)The study illustrates the safety of biologics.
(6)Only full-text papers are used to analyze.
Key exclusion criteria
(1)Systematic review or meta-analysis articles.
(2)Case reports or case series reporting less than 5 cases.
(3)The republished research literature is excluded unless the research includes new findings related to adverse events listed in inclusion criteria.
(4)Studies with no or insufficient safety results at the time of the literature search.
(5)Studies 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
| 2022 | Year | 10 | Month | 17 | 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
439
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
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will search for candidate articles using PubMed, Cochrane, EMBASE, and Web of Science Core Collection in October 2022.
Studies meeting the following criteria will be considered for inclusion:
Participants: The patients were clinically diagnosed with AOSD.
Intervention: Biological therapy.
Comparison: No comparison.
Outcome: Incidence of MAS and other adverse events.
Two investigators independently screened all titles, abstracts, and full texts for eligibility. Final inclusion will be decided after resolving discrepancies between the two investigators.
The risk of bias of each study will be assessed by the Newcastle-Ottawa Scale for cohort studies.
Management information
Registered date
| 2022 | Year | 10 | Month | 17 | Day |
Last modified on
| 2023 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056084
