UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046198
Receipt number R000052722
Scientific Title An observational study to determine biomarkers for prognosis of lung lesions in patients with polymyositis/dermatomyositis complicated by interstitial lung disease
Date of disclosure of the study information 2021/12/01
Last modified on 2023/05/27 11:37:15

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Basic information

Public title

An observational study to determine biomarkers for prognosis of lung lesions in patients with polymyositis/dermatomyositis complicated by interstitial lung disease

Acronym

PM/DM-ILD biomarkers study

Scientific Title

An observational study to determine biomarkers for prognosis of lung lesions in patients with polymyositis/dermatomyositis complicated by interstitial lung disease

Scientific Title:Acronym

PM/DM-ILD biomarkers study

Region

Japan


Condition

Condition

Polymyositis/dermatomyositis complicated with interstitial lung disease (PM/DM-ILD)

Classification by specialty

Medicine in general Pneumology Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to explore biomarkers that define the change of lung lesions in PM/DM-ILD when immunosuppressive therapy is to be initiated.

Basic objectives2

Others

Basic objectives -Others

Stratification of changes in lung lesions according to myositis-specific antibodies and search for biomarkers in bronchoalveolar lavage fluid that are associated with lung lesions.

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Search for biomarkers associated with change in high-resolution CT fibrosis volume and FVC change at 52 weeks from baseline

Key secondary outcomes

FVC at baseline assessment, 26 weeks, and 52 weeks
5% or more deterioration in relative change in %FVC at 52 weeks
5% or more improvement in relative change in %FVC at 52 weeks
10% or more deterioration in relative change in %FVC at 52 weeks
10% or more improvement in relative change in %FVC at 52 weeks
Lung fibrosis score at baseline assessment and at 52 weeks


Base

Study type

Observational


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients diagnosed with PM/DM according to the criteria of the Ministry of Health, Labour and Welfare, Bohen and Peter criteria, or Sontheimer's Clinically amyopathic dermatomyositis (CADM), or patients with positive myositis-specific autoantibodies
2) Patients with ILD
3) Patients who are 20 years of age or older at the time of obtaining consent.
4) Patients planning to receive immunosuppressive therapy or receiving corticosteroids only within 8 weeks.
5) Patients with fibrotic lung disease that affects lung capacity by more than 10% on high-resolution CT.
6) Patients with FVC more than 50% of predicted and DLCO of 20-89% predicted.
7) ability and willingness to provide written informed consent and comply with the requirements of the study protocol.

Key exclusion criteria

1) Patients who have received oral corticosteroids for more than 8 weeks prior to obtaining consent.
2) Patients with malignant tumors.
3) Patients who are using or have used an anti-fibrotic therapy.
4) Patients who have undergone more than lobectomy.
5) Other patients deemed inappropriate by the investigator.

Target sample size

125


Research contact person

Name of lead principal investigator

1st name Atsushi
Middle name
Last name Kawakami

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Department of Immunology and Rheumatology

Zip code

8528501

Address

1-7-1 Sakamoto, Nagasaki, Nagasaki, 852-8501, Japan

TEL

095-819-7260

Email

atsushik@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Toshimasa
Middle name
Last name Shimizu

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Department of Immunology and Rheumatology

Zip code

8528501

Address

1-7-1 Sakamoto, Nagasaki, Nagasaki, 852-8501, Japan

TEL

095-819-7262

Homepage URL


Email

t.shimizu@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University

Institute

Department

Personal name



Funding Source

Organization

Boehringer Ingelheim Japan, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagasaki University Hospital Clinical Research Ethics Committee

Address

1-7-1 Sakamoto, Nagasaki, Nagasaki, 852-8501, Japan

Tel

095-819-7229

Email

gaibushikin@ml.nagasaki-u.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

2021 Year 12 Month 01 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

Enrolling by invitation

Date of protocol fixation

2021 Year 10 Month 13 Day

Date of IRB

2021 Year 11 Month 22 Day

Anticipated trial start date

2021 Year 12 Month 15 Day

Last follow-up date

2025 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The study period is from the time of obtaining consent to 52 weeks.


Management information

Registered date

2021 Year 11 Month 26 Day

Last modified on

2023 Year 05 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052722


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name