UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028406
Receipt number R000032181
Scientific Title Observational study of rheumatic disease for early diagnosis, elucidation of pathogenesis, and establishment of therapeutic strategy
Date of disclosure of the study information 2017/08/16
Last modified on 2023/01/30 16:36:59

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Basic information

Public title

Observational study of rheumatic disease for early diagnosis, elucidation of pathogenesis, and establishment of therapeutic strategy

Acronym

KURAMA cohort study

Scientific Title

Observational study of rheumatic disease for early diagnosis, elucidation of pathogenesis, and establishment of therapeutic strategy

Scientific Title:Acronym

KURAMA cohort study

Region

Japan


Condition

Condition

Rheumatic diseases

Classification by specialty

Clinical immunology Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To establish the diagnostic criteria and treatment strategy for rheumatic diseases.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Disease activity of rheumatic diseases

Key secondary outcomes



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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

All the rheumatic disease patients who visited our department and agreed for the study

Key exclusion criteria

Patients with dementia

Target sample size

3000


Research contact person

Name of lead principal investigator

1st name Kosaku
Middle name
Last name Murakami

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Rheumatology and Clinical Immunology

Zip code

606-8507

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto

TEL

075-751-4380

Email

kosaku@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Kosaku
Middle name
Last name Murakami

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Rheumatology and Clinical Immunology

Zip code

606-8507

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto

TEL

075-751-4380

Homepage URL


Email

kosaku@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University

Institute

Department

Personal name



Funding Source

Organization

DAIICHI SANKYO COMPANY, LIMITED; Mitsubishi Tanabe Pharma Corporation; CHUGAI PHARMACEUTICAL CO., LTD; AYUMI Pharmaceutical Corporation; UCB Japan Co. Ltd

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

Kyoto University Graduate School of Medicine

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto

Tel

0757514380

Email

kosaku@kuhp.kyoto-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

京都大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2017 Year 08 Month 16 Day


Related information

URL releasing protocol

https://www.racenter.kuhp.kyoto-u.ac.jp/activity/running-study/kurama-study/papers

Publication of results

Unpublished


Result

URL related to results and publications

https://www.racenter.kuhp.kyoto-u.ac.jp/activity/running-study/kurama-study/papers

Number of participants that the trial has enrolled

1460

Results

From KURAMA cohort Registry, a number of research articles hase been published until the end of 2022.

Results date posted

2023 Year 01 Month 30 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Rheumatoid arhtirits patients who have been admitted on Kyoto University Hospital and assigned the informed concent of the study.

Participant flow

Clinical information of ordinaly practice for rheumatoid arthritis was obtained.

Adverse events

No adverse event was reported because the study was a retrospective observational study.

Outcome measures

All the data related with clinical information of rheumatoid arhtirits without private information.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2016 Year 03 Month 24 Day

Date of IRB

2019 Year 05 Month 30 Day

Anticipated trial start date

2016 Year 03 Month 24 Day

Last follow-up date

2022 Year 01 Month 11 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Nothing declared


Management information

Registered date

2017 Year 07 Month 27 Day

Last modified on

2023 Year 01 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032181


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name