UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Neutralizing antibody of Interferon beta on multiple sclerosis (Multi-center clinical studies)
Title of the study (Brief title)	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	Shigeru Koyano
Organization	Yokohama City University
Division name	Department of Neurology
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2725
Email	koya77@med.yokohama-cu.ac.jp

Public contact
Name of contact person	Douglas Sato
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Multiple Sclerosis Therapeutics
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000009647