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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006153
Receipt No. R000007116
Scientific Title Multicenter Randomized control study of Immunoadsorption therapy (IAPP) for acute attacks relapsing-remitting Multiple Sclerosis
Date of disclosure of the study information 2011/09/01
Last modified on 2020/02/10

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Basic information
Public title Multicenter Randomized control study of Immunoadsorption therapy (IAPP) for acute attacks relapsing-remitting Multiple Sclerosis
Acronym Japanese trial of Immunoadsorption therapy for acute attacks of relapsing-remitting Multiple Sclerosis (JIMS study)
Scientific Title Multicenter Randomized control study of Immunoadsorption therapy (IAPP) for acute attacks relapsing-remitting Multiple Sclerosis
Scientific Title:Acronym Japanese trial of Immunoadsorption therapy for acute attacks of relapsing-remitting Multiple Sclerosis (JIMS study)
Region
Japan

Condition
Condition Relapsing-remitting Multiple Sclerosis
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Multicenter Randomized control study of Immunoadsorption therapy (IAPP) for acute attacks relapsing-remitting Multiple Sclerosis is aimed to evaluate the efficacy of IAPP compare to the intra vinous steroids pause therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changing EDSS score at 3 weeks
Key secondary outcomes EDSS score, FS grade
QOL assessment
MRI, Blood tests

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 IAPP group
:treated by Immunoadsorption theapy 5 times/2weeks
Interventions/Control_2 HIMP control group
:treated by steroid pulse therapy (1g/day), 3 3sessions/week during 2weeks.
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
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Relapsing-remitting Multiple Sclerosis patients fulfill the McDonald diagnostic criteria.
Key exclusion criteria High-risk patients of hypovolemia with sever cardiovascular disease, brain disorder and autonomic disorder.

MRI evidence of a contiguous spinal cord lesion 3 or more segments in length and/or anti-AQP4-IgG seronegativity.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TAKASHI YAMAMURA, M.D., Ph., D.
Organization National Center of Neurology and Psychiatry
Division name Department of Immunology
Zip code
Address 4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8502, Japan
TEL 042-341-2711
Email

Public contact
Name of contact person
1st name
Middle name
Last name LIN YOUWEI, MD.,
Organization National Center of Neurology and Psychiatry
Division name National Center Hospital
Zip code
Address 4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8502, Japan
TEL
Homepage URL
Email

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 独立行政法人 国立精神・神経医療研究センター(東京都)
順天堂大学医学部附属順天堂医院(東京都)
横浜市立大学附属病院(神奈川県)
東京女子医科大学八千代医療センター(千葉県)
横浜労災病院(神奈川県)
東京女子医科大学東医療センター(東京都)
大森赤十字病院(東京都)
東京医科大学八王子医療センター(東京都)
東京女子医科大学病院(東京都)
聖マリアンナ医科大学病院(神奈川県)
千葉大学医学部附属病院(千葉県)

Other administrative information
Date of disclosure of the study information
2011 Year 09 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 Terminated
Date of protocol fixation
2010 Year 12 Month 27 Day
Date of IRB
2011 Year 10 Month 28 Day
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2015 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
2011 Year 08 Month 12 Day
Last modified on
2020 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007116

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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