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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008186
Receipt No. R000009647
Scientific Title Neutralizing antibody of Interferon beta on multiple sclerosis (Multi-center clinical studies)
Date of disclosure of the study information 2012/07/01
Last modified on 2017/06/20

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Basic information
Public title Neutralizing antibody of Interferon beta on multiple sclerosis
(Multi-center clinical studies)
Acronym Neutralizing antibody of IFN-beta on MS
(Multi-center clinical studies)
Scientific Title Neutralizing antibody of Interferon beta on multiple sclerosis
(Multi-center clinical studies)
Scientific Title:Acronym Neutralizing antibody of IFN-beta on MS
(Multi-center clinical studies)
Region
Japan

Condition
Condition Multiple sclerosis
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify a utility of the examination system of measurement neutralizing antibody of interferon beta on multiple sclerosis and analyze the frequency of antibody positive
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To analyze the frequency of neutralizing antibody positive of interferon beta
Key secondary outcomes

Base
Study type Interventional

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 Prevention
Type of intervention
Maneuver
Interventions/Control_1 Blood for analysis (10ml)
Term of analysis is from January 13, 2012 to March 31, 2016.
Frequency of analysis is a time or two.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Among MS patients during IFN -beta treatment, the group of patients that the IFN-beta neutralizing antibody is useful
Key exclusion criteria Not MS patients
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Koyano
Organization Yokohama City University
Division name Department of Neurology
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama
TEL 045-787-2725
Email koya77@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Douglas Sato
Organization Tohoku University Graduate School of Medicine
Division name Department of Multiple Sclerosis Therapeutics
Zip code
Address 1-1 Seiryo-cho, Aoba-ku, Sendai
TEL 022-717-7190
Homepage URL
Email nab@neurol.med.tohoku.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization None
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

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 01 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 Open public recruiting
Date of protocol fixation
2012 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2016 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 06 Month 16 Day
Last modified on
2017 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009647

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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