UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of rituximab for intractable immunogenic neurological disorder in children
Title of the study (Brief title)	rituximab for pediatric neurological disorder
Region	Japan

Condition
Condition	neuromyelitis optica (NMO), opsoclonus-myoclonus syndrome (OMS)
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Efficacy and safety of rituximab for neuromyelitis optica and opsoclonus-myoclonus syndrome
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Clinical symptom, recurrence ratio, total dose of steroid
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	administration of 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	18 years-old >
Gender	Male and Female
Key inclusion criteria	The NMO and OMS patiets 1) are less than 18-year-old patient, 2) are not effective steroid, the plasma exchange, and immunoglobulin medication, or who are anxious about strong side effects, 3) are able to be hospitalized, 4) are obtained informed-consent.
Key exclusion criteria	The patients 1) are affected for infectious disease, 2) are recieved live vaccine within 4weeks, 3) are suffered from heart, lung, liver and kidney disease, 4) have the allergy for rituximab, 5) are ruled unfit to this study.
Target sample size	10

Research contact person
Name of lead principal investigator	Hiroaki Nagase
Organization	Kobe University Graduate School of Medicine
Division name	Department of Pediatrics
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL	078-382-6090
Email	nagase@med.kobe-u.ac.jp

Public contact
Name of contact person	Hiroaki Nagase
Organization	Kobe University Graduate School of Medicine
Division name	Department of Pediatrics
Address	7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL	078-382-6090
Homepage URL
Email	nagase@med.kobe-u.ac.jp

Sponsor
Institute	Department of Pediatrics, Kobe Universtiy Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
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	神戸大学病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2012 Year 11 Month 28 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2012 Year 06 Month 28 Day
Anticipated trial start date	2012 Year 06 Month 28 Day
Last follow-up date	2016 Year 03 Month 31 Day
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	2012 Year 11 Month 28 Day
Last modified on	2016 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009223