UMIN-CTR Clinical Trial

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

Systemic lupus erythematosus

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

IRGs expression levels in Japanese SLE patients

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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 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 2003.
-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

Name of lead principal investigator

1st name
Middle name
Last name	Tomonori Ishii

Organization

TOHOKU UNIVERSITY HOSPITAL

Division name

Hematology and rheumatology

Zip code

Address

1-1,Seiryoucho,Aoba-ku,Sendai-shi, Miyagi, JAPAN

TEL

Email

Name of contact person

1st name
Middle name
Last name	Tomonori Ishii

Organization

TOHOKU UNIVERSITY HOSPITAL

Division name

Hematology and rheumatology

Zip code

Address

1-1,Seiryoucho,Aoba-ku,Sendai-shi, Miyagi, JAPAN

TEL

Homepage URL

Email

Institute

Chugai Pharmaceutical co., ltd.

Institute

Department

Personal name

Organization

Chugai Pharmaceutical co., ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

10

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

08

Month

02

Day

Date of IRB

Anticipated trial start date

2012

Year

10

Month

20

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

One point blood sampling and examination of IRGs expression levels.

Registered date

2012

Year

10

Month

04

Day

Last modified on

2013

Year

12

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010612