UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017559
Receipt number R000020351
Scientific Title To elucidate pathology of autoimmune disease and develop new treatment
Date of disclosure of the study information 2015/05/14
Last modified on 2015/05/14 12:43:36

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Basic information

Public title

To elucidate pathology of autoimmune disease and develop new treatment

Acronym

Development of new treatment in autoimmun diseases

Scientific Title

To elucidate pathology of autoimmune disease and develop new treatment

Scientific Title:Acronym

Development of new treatment in autoimmun diseases

Region

Japan


Condition

Condition

autoimmune diseases

Classification by specialty

Medicine in general Clinical immunology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To elucidate pathology of autoimmun disease and develop effective treatment

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Efficacy at following visits

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

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who are suffring from RA,SLE,pSS, SS, PM/DM. MCTD, MG, MS

Key exclusion criteria

Patients who thier physicians consider as not appropriate

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsutomu Takeuchi

Organization

Keio University School of Medicine

Division name

Division of Rheumatology, Department of Internal Medicine

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN

TEL

03-3353-1211

Email

tsutake@z5.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuko Kaneko

Organization

Keio University School of Medicine

Division name

Division of Rheumatology, Department of Internal Medicine

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN

TEL

03-3353-1211

Homepage URL


Email

ykaneko@z6.keio.jp


Sponsor or person

Institute

Keio University

Institute

Department

Personal name



Funding Source

Organization

Keio University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2015 Year 05 Month 14 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2010 Year 06 Month 07 Day

Date of IRB


Anticipated trial start date

2010 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To elucidate patology and develop treatment by analyzing mRNA, cell surface markers, cytokines when using treatment


Management information

Registered date

2015 Year 05 Month 14 Day

Last modified on

2015 Year 05 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020351


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name