UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008987
Receipt number R000010537
Scientific Title A study of expression levels of the interferon regulated genes in Japanese systemic lupus erythematosus patients with moderate to severe disease activities and healthy adults
Date of disclosure of the study information 2012/09/26
Last modified on 2013/12/03 15:32:34

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Basic information

Public title

A study of expression levels of the interferon regulated genes in Japanese systemic lupus erythematosus patients with moderate to severe disease activities and healthy adults

Acronym

A study of expression levels of the interferon regulated genes in Japanese systemic lupus erythematosus patients

Scientific Title

A study of expression levels of the interferon regulated genes in Japanese systemic lupus erythematosus patients with moderate to severe disease activities and healthy adults

Scientific Title:Acronym

A study of expression levels of the interferon regulated genes in Japanese systemic lupus erythematosus patients

Region

Japan


Condition

Condition

Systemic lupus erythematosus

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the expression levels of interferon regulated genes (IRGs) in SLE patients with moderate to severe Extra-Renal diseases (ERL) and Lupus Nephritis (LN) and Japanese healthy adults, and to evaluate the relation between IRGs expression and SLE disease activity

Basic objectives2

Others

Basic objectives -Others

An observational study to examine IRGs expression levels in Japanese SLE patients

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

IRGs expression levels in Japanese SLE patients

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

(ERL)
-Diagnosis of SLE according to current American College of Rheumatology (ACR) criteria and 12 months or more disease duration
(LN)
-Diagnosis of SLE according to current ACR criteria and diagnosis of Class III or IV lupus nephritis based on International Society of Nephrology/Renal Pathology Society
-1+ or more Proteinuria with qualitative urinalysis
-Proteinuria with a urinary protein/creatinine ratio of 0.5 or higher
(Healthy adults)
-Healthy Japanese

Key exclusion criteria

(ERL/LN)
-Unstable neuropsychiatric SLE at the time of sampling
-Evidence of significant uncontrolled concomitant diseases (e.g., cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders) at the time of sampling
-Conditions other than SLE that could require treatment with corticosteroids (e.g., asthma) at the time of within 12 months prior to sampling
-History of cancer within 5 years prior to sampling
-History of congenital immunodeficiency
-Signs or symptoms of infection within 31 days prior to sampling
(Healthy adults)
-Evidence of concomitant diseases (e.g., cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders) at the time of sampling
-History of cancer within 5 years prior to sampling
-Any clinically abnormal conditions at the time of sampling
-Signs or symptoms of infection within 31 days prior to sampling

Target sample size

110


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomoya Miyamura

Organization

NATIONAL HOSPITAL ORGANIZATION
KYUSHU MEDICAL CENTER

Division name

Rheumatology and internal medicine

Zip code


Address

1-8-1 Jigyouhama, Chuo-ku Fukuoka-shi, Fukuoka, JAPAN

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

NATIONAL HOSPITAL ORGANIZATION KYUSHU MEDICAL CENTER

Division name

Rheumatology and internal medicine

Zip code


Address

1-8-1 Jigyouhama, Chuo-ku Fukuoka-shi, Fukuoka, JAPAN

TEL


Homepage URL


Email



Sponsor or person

Institute

Chugai Pharmaceutical co., ltd.

Institute

Department

Personal name



Funding Source

Organization

Chugai Pharmaceutical 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


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

2012 Year 09 Month 26 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

2012 Year 08 Month 02 Day

Date of IRB


Anticipated trial start date

2012 Year 10 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

One point blood sampling and examination of IRGs expression levels.


Management information

Registered date

2012 Year 09 Month 26 Day

Last modified on

2013 Year 12 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010537


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name