UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Rituximab for anti-NMDAR encephalitis
Title of the study (Brief title)	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	Ryuji Kaji
Organization	Tokushima University Hospital
Division name	Neurology
Address	3-18-15 Kuramoto-cho, Tokushima, Tokushima
TEL	088-633-7207
Email	rkaji@tokushima-u.ac.jp

Public contact
Name of contact person	Naoko Matsui
Organization	Tokushima University Hospital
Division name	Neurology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 02 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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