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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012844
Receipt No. 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

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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
Institute Juntendo University, Sclool of Medicine
Institute
Department

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
URL(English) https://upload.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


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