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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
