UMIN-ICDS Clinical Trial

Public title

Clinical implications of myositis autoantibody levels in people living with myositis

Acronym

Clinical implications of myositis autoantibody levels

Scientific Title

Clinical implications of myositis-specific autoantibody levels in patients with idiopathic inflammatory myopathies

Scientific Title:Acronym

Clinical implications of MSA levels in IIM

Region

Japan	Asia(except Japan)	North America
South America	Australia	Europe

Condition

Idiopathic inflammatory myopathies

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the association of myositis-specific autoantibody (MSA) levels, as measured by enzyme-linked immunosorbent assay (ELISA), with myositis disease activity measures in patients with idiopathic inflammatoory myopathies (IIMs).

Basic objectives2

Others

Basic objectives -Others

This study will explore longitudinal trajectories of MSA levels over the disease course.

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

The primary objective of this study is the correlation between each MSA level measured by ELISA and myositis disease activity. Specifically, we will evaluate the correlation between each MSA level and Physician gloval activity, a measure of myositis disease activity, at diagnosis for cases included in the retrospective cohort, and at the time of registration (0M) and at 3, 6, 9, and 12M after registration for cases enrolled in the prospective cohort, using Spearman's correlation coefficient.

Key secondary outcomes

We will evaluate the correlation between each MSA level and myositis disease activity measures other than Physician global activity (Patient global activity, Manual Muscle Testing-8 (MMT-8), Health Assessment Questionnaire Disability Index (HAQ-DI), Extra-muscular global disease activity, muscle enzymes including CK, AST, ALT, LDH, and aldolase, Myositis Disease Activity Assessment Tool (MDAAT), Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), Childhood Myositis Assessment Scale (CMAS), Childhood Health Assessment Questionnaire (CHAQ), and Disease Activity Score (DAS)) at diagnosis for cases included in the retrospective cohort, and at the time of registration (0M) and at 3, 6, 9, and 12M after registration for cases enrolled in the prospective cohort, using Spearman's correlation coefficient.

Study type

Observational

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Individuals who meet the following criteria are eligible for the study:
1. Individuals who meet any of the following classification criteria for IIM:
1.1. 2017 European Alliance and Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) classification criteria for IIM
1.2. 224th European Neuromuscular Centre (ENMC) Workshop classification criteria for immune-mediated necrotizing myopathy
1.3. Connors' criteria for anti-synthetase syndrome
2. Individuals who are positive for any of the following MSAs by autoantibody testing at each participating centre
2.1. Anti-Jo-1 autoantibody
2.2. Anti-MDA5 autoantibody
2.3. Anti-Mi-2 autoantibody
2.4. Anti-NXP2 autoantibody
2.5. Anti-SAE autoantibody
2.6. Anti-TIF1-gamma autoantibody
2.7. Anti-SRP autoantibody
2.8. Anti-HMGCR autoantibody

Key exclusion criteria

Individuals deemed unsuitable for participation in this study by the principal investigator or co-investigators

Target sample size

1150

Name of lead principal investigator

1st name	Sarah
Middle name
Last name	Tansley

Organization

University of Bath

Division name

Department of Life Sciences

Zip code

BA2 7AY

Address

Claverton Down, Bath, United Kingdom

TEL

+441225388388

Email

slt32@bath.ac.uk

Name of contact person

1st name	Akira
Middle name
Last name	Yoshida

Organization

Nippon Medical School Hospital

Division name

Department of Allergy and Rheumatology

Zip code

113-8602

Address

1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan

TEL

0358146017

Homepage URL

Email

a-yoshida@nms.ac.jp

Institute

International Myositis Assessment and Clinical Studies Group (IMACS)

Institute

Department

Personal name

Organization

Not applicable

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Central Ethics Committee of Nipppon Medical School Foundation

Address

1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan

Tel

0338222131

Email

chuorinri.group@nms.ac.jp

Secondary IDs

YES

Study ID_1

IMACS project XLI (Protocol ID: M-2025-426)

Org. issuing International ID_1

International Myositis Assessment and Clinical Studies Group (IMACS)

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2025

Year

11

Month

27

Day

Date of IRB

2025

Year

11

Month

27

Day

Anticipated trial start date

2025

Year

11

Month

27

Day

Last follow-up date

2030

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is an international collaborative observational study involving 50 centres across 21 countries belonging to the Autoantibody Special Interest Group (SIG) of the International Myositis Assessment and Clinical Studies (IMACS). This study encompasses two independent study cohorts:
1) A retrospective cohort, in which we will analyse clinical data and blood samples that were collected through previous or ongoing clinical studies in participating centres.
2) A prospective cohort, in which we will register newly-diagnosed patients with IIMs in participating centres and collect clinical data and blood samples every three months for one year following diagnosis.
In the retrospective cohort, where feasible, clinical data and blood samples will be prospectively collected from study participants for one year after registration, with their consent.
This is an exploratory, non-interventional clinical study. This study involves a minor invasive procedure, as it requires phlebotomy to obtain research blood samples in addition to routine clinical blood tests in the prospective cohort (and for some participants in the retrospective cohort who have provided consent).

Registered date

2026

Year

08

Month

01

Day

Last modified on

2026

Year

08

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071454