UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026293 |
|---|---|
| Receipt number | R000030200 |
| Scientific Title | Rituximab for anti-NMDAR encephalitis |
| Date of disclosure of the study information | 2017/03/31 |
| Last modified on | 2017/02/24 17:02:06 |
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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
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
naoko@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030200
