UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006153 |
|---|---|
| Receipt number | 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 12:01:53 |
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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
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
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007116
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| Registered date | File name |
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| Registered date | File name |
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