UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005797
Receipt number R000006860
Scientific Title Assay for detection of neutralizing antibodies against interferon-beta in multiple sclerosis
Date of disclosure of the study information 2011/06/20
Last modified on 2015/06/18 17:39:58

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Basic information

Public title

Assay for detection of neutralizing antibodies against interferon-beta in multiple sclerosis

Acronym

Assay for detection of neutralizing antibodies against interferon-beta in multiple sclerosis

Scientific Title

Assay for detection of neutralizing antibodies against interferon-beta in multiple sclerosis

Scientific Title:Acronym

Assay for detection of neutralizing antibodies against interferon-beta in multiple sclerosis

Region

Japan


Condition

Condition

multiple sclerosis

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Analysis of frequency and significance of interferon-beta neutralizing antibody in Japanese patients with multiple sclerosis treated by interferon-beta

Basic objectives2

Others

Basic objectives -Others

epidemiology

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Analysis of frequency of interferon-beta neutralizing antibody in Japanese patients with multiple sclerosis treated by 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

Other

Interventions/Control_1

neutralizing antibody assay

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

multiple sclerosis treating with interferon-beta

Key exclusion criteria

none

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ichiro Nakashima

Organization

Tohoku University School of Medicine

Division name

Department of Neurology

Zip code


Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7188

Email

ichiro.nakashima@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Ichiro Nakashima

Organization

Tohoku Univesity School of Medicine

Division name

Department of Neurology

Zip code


Address

1-1 Seiryo-machi, Aoba-ku, Sendai

TEL

022-717-7188

Homepage URL


Email

ichiro.nakashima@gmail.com


Sponsor or person

Institute

Department of Neurology, Tohoku University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

MEXT

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Juntendo University School of Medicine
Tokyo Women's Medical University

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

2011 Year 06 Month 20 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

5% of the patients with interferon-beta-1a and 10% of the patients with interferon-beta-1b revealed to have high titer of neutralizing antibody and seemed to be influenced to clinical course.

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

Completed

Date of protocol fixation

2011 Year 06 Month 17 Day

Date of IRB


Anticipated trial start date

2011 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2015 Year 03 Month 31 Day


Other

Other related information

Analysis of inerferon-beta neutralizing antibodies


Management information

Registered date

2011 Year 06 Month 18 Day

Last modified on

2015 Year 06 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006860


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name