UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012844
Receipt number R000014907
Scientific Title The examination of the usefulness of anti-Sm antibody mesuremant with SmD peptide.
Date of disclosure of the study information 2014/01/14
Last modified on 2015/01/16 18:44:01

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Basic information

Public title

The examination of the usefulness of anti-Sm antibody mesuremant with SmD peptide.

Acronym

The examinatin of the usefulness of
anti-Sm antibody mesuremant with SmD peptide.

Scientific Title

The examination of the usefulness of anti-Sm antibody mesuremant with SmD peptide.

Scientific Title:Acronym

The examinatin of the usefulness of
anti-Sm antibody mesuremant with SmD peptide.

Region

Japan


Condition

Condition

Systemic lupus erythematosus,Mixed connective tissue disease,Sjogren's syndrome,Polymyositis/Dermatomyositis,Rheumatoid arthritis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of the clinical utility of the new and old anti Sm (EliA SmDp and EliA Sm )antibody tests for systemic lupus erythematosus.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Correlatitivity and concordance rate between Elia SmDp and Elia Sm,
Clinical sensitivity,specificity and ROC analysis of Elia SmDp and Elia SmD,
Antibody titer of Elia SmDp and Elia SmD for control disease,
Conformation test in discordant samples between Elia SmDp and Elia SmD

Key secondary outcomes



Base

Study type


Study design

Basic design

Single arm

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

obtain a blood sample

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

To meet following criteria.
SLE classification criteria,
SS diagnostic criteria,
SSc diagnostic criteria,
PM/DM diagnostic criteria,
RA classification criteria.

Key exclusion criteria

Patient diagnosed with overlap syndrome

Target sample size

225


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshinari Takasaki

Organization

Juntendo University, Sclool of Medicine

Division name

Depertment of internal medicine and rheumatology

Zip code


Address

3-1-3 hongou bunnkyou-ku, Tokyo Japan

TEL

03-3813-3111

Email

tyoshi@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masakazu matsushita

Organization

Juntendo University, Sclool of Medicine

Division name

Depertment of internal medicine and rheumatology

Zip code


Address

3-1-3 hongou bunnkyou-ku, Tokyo Japan

TEL

03-3813-3111

Homepage URL


Email

collagen@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University, Sclool of Medicine

Institute

Department

Personal name



Funding Source

Organization

Phadia K.K.

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

2014 Year 01 Month 14 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

2.sensitivity and specificity
The sensitivity of EliA SmDp, EliA Sm and DID were 14.4%, 1.9% and 4.8% respectively.
The sensitivity of EliA SmDp, EliA Sm and DID were 94.2%, 98.3% and 98.3% respectively.

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

2013 Year 01 Month 27 Day

Date of IRB


Anticipated trial start date

2014 Year 02 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



Management information

Registered date

2014 Year 01 Month 14 Day

Last modified on

2015 Year 01 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014907


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name