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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026293
Receipt No. R000030200
Scientific Title Rituximab for anti-NMDAR encephalitis
Date of disclosure of the study information 2017/03/31
Last modified on 2017/02/24

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Basic information
Public title Rituximab for anti-NMDAR encephalitis
Acronym Rituximab for anti-NMDAR encephalitis
Scientific Title Rituximab for anti-NMDAR encephalitis
Scientific Title:Acronym Rituximab for anti-NMDAR encephalitis
Region
Japan

Condition
Condition anti-NMDAR encephalitis
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To improve symptoms in intractable patients with anti-NMDAR encephalitis using rituixmab
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes cerebrospinal fluid (anti-NMDAR antibodies titer)
This item is evaluated before and after RTX administration (at 1, 3, 6months)
Key secondary outcomes blood examination (CD20+ lymphocyte, anti-NMDAR antibodies titer)
brain MRI
EEG
modified Rankin scale
These items are evaluated before and after RTX administration (at 1, 3, 6, 9, and 12 months)

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Rituximab
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
15 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria intractable patients with anti-NMDAR encephalitis
Key exclusion criteria infant, pregnant woman
Target sample size 2

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuji Kaji
Organization Tokushima University Hospital
Division name Neurology
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima, Tokushima
TEL 088-633-7207
Email rkaji@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko Matsui
Organization Tokushima University Hospital
Division name Neurology
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima, Tokushima
TEL 088-633-7207
Homepage URL
Email naoko@tokushima-u.ac.jp

Sponsor
Institute Tokushima University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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 徳島大学病院

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 31 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 Preinitiation
Date of protocol fixation
2017 Year 02 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 24 Day
Last modified on
2017 Year 02 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030200

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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