UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047794
Receipt number R000054485
Scientific Title Japan-systemic sclerosis observational study and registry
Date of disclosure of the study information 2022/05/18
Last modified on 2022/05/18 17:34:40

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Basic information

Public title

Japan-systemic sclerosis observational study and registry

Acronym

J-STAR

Scientific Title

Japan-systemic sclerosis observational study and registry

Scientific Title:Acronym

J-STAR

Region

Japan


Condition

Condition

Systemic sclerosis

Classification by specialty

Clinical immunology Chest surgery Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In this registry, data shown below will be collected prospectively and retrospectively.
To assess prevalence rate of SSc organ involvement, mortality rate, and time to organ involvement in Japanese patients with systemic sclerosis (SSc).
To assess cumulative frequency of progressive fibrosing interstitial lung disease (ILD) in Japanese patients with SSc for 12 and 36 months of follow-up.
To identify clinical and physiological findings, imaging features, and biomarkers that predict SSc major organ involvement, including progression of ILD.

Basic objectives2

Others

Basic objectives -Others

Others

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Time to onset of SSc organ involvement defined by previous studies
A)ILD
B)PH
C)Renal crisis
D)Upper gastrointestinal involvement
E)Lower gastrointestinal involvement
F)Myocardial involvement
G)Digital ulcer

Key secondary outcomes

A)Time to onset of organ failure event
B)Time to death
C)Rate of patients who meet the criteria of low disease activity advocated by World Scleroderma Foundation: WSF (at 1, 2, 3 years)
D)Rate of patients with progressive pulmonary fibrosis (at 1, 3 years)
E)Predictive factor for progression of pulmonary fibrosis in patients with SSc-ILD


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 who give written consent (provide opportunity to refuse, to the patients who had been registered in EUSTAR database and with difficulty in written consent)
2)20 years or older at the time of consent
3)Patients who are diagnosed as having SSc and meet the 2013 American college of Rheumatology (ACR)/ European League against Rheumatism (EULAR) classification criteria for SSc;
4)Patients with or without ILD. In case of SSc-ILD patients, ILD has been confirmed by high-resolution computed tomography (HRCT) at the time of baseline or follow-up.
5)Accepted whether registered in EUSTAR database or not. In patients who have been registered in EUSTAR database, the data recorded in EUSTAR database may be collected retrospectively.

Key exclusion criteria

1)Participation in clinical trials for NDA concurrently or scheduled during this registry, excluding studies other than clinical trials for NDA (e.g., specified clinical trial defined in Clinical Trials Act)
2)Unsuitable for enrolment into this study by the investigator's or sub-investigator's judgment

Target sample size

800


Research contact person

Name of lead principal investigator

1st name Masataka
Middle name
Last name Kuwana

Organization

Nippon Medical School Hospital

Division name

Department of Rheumatology

Zip code

113-8603

Address

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

TEL

03-3822-2131

Email

kuwanam@nms.ac.jp


Public contact

Name of contact person

1st name Takako
Middle name
Last name Osato

Organization

EPS Corporation

Division name

Clinical Research Center, Real World Evidence Business Headquarters

Zip code

162-0814

Address

Acropolis TOKYO, 6-29 Shin-ogawamachi, Shinjuku-ku, Tokyo, Japan

TEL

03-5804-5045

Homepage URL


Email

prj-jstar@eps.co.jp


Sponsor or person

Institute

NPO Japan PH Registry

Institute

Department

Personal name



Funding Source

Organization

Nippon Boehringer lngelheim Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Central Ethics Committee of Nippon Medical School

Address

1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan 113-8603

Tel

03-3822-2131

Email

chuorinri.group@nms.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

日本医科大学付属病院(東京都)、公立陶生病院(愛知県)、産業医科大学病院(福岡県)、北海道大学病院(北海道)、東京女子医科大学病院(東京都)、藤田医科大学病院(愛知県)、札幌医科大学附属病院(北海道)、長崎大学病院(長崎県)、浜松医科大学医学部附属病院(静岡県)、久留米大学病院(福岡県)、大阪医科薬科大学病院(大阪府)、香川大学医学部附属病院(香川県)、学校法人北里研究所 北里大学病院(神奈川県)、慶應義塾大学病院(東京都)、東北大学病院(宮城県)
、地方独立行政法人 神奈川県立病院機構 神奈川県立循環器呼吸器病センター 
(神奈川県)、徳島大学病院(徳島県)、九州大学病院(福岡県)、独立行政法人 地域医療機能推進機構 中京病院(愛知県)、公立大学法人 横浜市立大学附属病院(神奈川県)


Other administrative information

Date of disclosure of the study information

2022 Year 05 Month 18 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

Open public recruiting

Date of protocol fixation

2021 Year 10 Month 21 Day

Date of IRB

2021 Year 12 Month 20 Day

Anticipated trial start date

2022 Year 01 Month 05 Day

Last follow-up date

2028 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

NA


Management information

Registered date

2022 Year 05 Month 18 Day

Last modified on

2022 Year 05 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054485


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name