UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012916
Receipt number R000015021
Scientific Title Analysis of immune status in autoimmune diseases treated with Biologics
Date of disclosure of the study information 2014/01/21
Last modified on 2014/01/21 22:40:30

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Basic information

Public title

Analysis of immune status in autoimmune diseases treated with Biologics

Acronym

Analysis of immune status in autoimmune diseases treated with Biologics

Scientific Title

Analysis of immune status in autoimmune diseases treated with Biologics

Scientific Title:Acronym

Analysis of immune status in autoimmune diseases treated with Biologics

Region

Japan


Condition

Condition

Autoimmune diseases

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To analyze the changes of immune status in the patients with autoimmune diseases being treated with biologics.

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase IV


Assessment

Primary outcomes

Biomarkers in sera and the surface markers on peripheral blood cells mRNA of
disease related molecules were analyzed by ELISA,FACS and RT-PCR in autoimmune
diseases treated with biologics

Key secondary outcomes

To evaluate efficacy of Biologics
-clinical assessment;DAS 28,High sensitivity C-reactive protein etc.


Base

Study type


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Biologics

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

Males and Females diagnosed rheumatoid arthritis must
-be more than 20 years old
-be informed and will give written informed consent

Key exclusion criteria

-Complicated with active infectious disease
-The Petients who the doctors in charge
consider should not enter this study

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsushi Ogata

Organization

Osaka University

Division name

Department of Respiratory Medicine, Allergy and Rheumatic Disease

Zip code


Address

2-2 Yamadaoka,Suita,Osaka 565-0871

TEL

06-6879-3833

Email

ogata@imed3.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Atsushi Ogata

Organization

Osaka University

Division name

Department of Respiratory Medicine, Allergy and Rheumatic Disease

Zip code


Address

2-2 Yamadaoka,Suita,Osaka 565-0871

TEL

06-6879-3833

Homepage URL


Email

ogata@imed3.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University

Institute

Department

Personal name



Funding Source

Organization

Osaka 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

大阪大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 21 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

Completed

Date of protocol fixation

2008 Year 08 Month 20 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 15 Day

Last follow-up date

2014 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2013 Year 01 Month 01 Day


Other

Other related information



Management information

Registered date

2014 Year 01 Month 21 Day

Last modified on

2014 Year 01 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015021


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name