UMIN-ICDS Clinical Trial

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

Adult-onset Still's disease

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

kaoru_t@yokohama-cu.ac.jp

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

Email

kaoru_t@yokohama-cu.ac.jp

Institute

Yokohama City University Graduate School of Medicine

Institute

Department

Personal name

Organization

Yokohama City University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Yokohama City University Graduate School of Medicine

Address

3-9, Kanazawa, Fukuura, Yokohama

Tel

045-787-2630

Email

kaoru_t@yokohama-cu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

10

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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/icdr_e/ctr_view.cgi?recptno=R000056084