UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009421
Receipt number R000009223
Scientific Title Efficacy and safety of rituximab for intractable immunogenic neurological disorder in children
Date of disclosure of the study information 2012/11/28
Last modified on 2016/06/29 11:04:50

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Basic information

Public title

Efficacy and safety of rituximab for intractable immunogenic neurological disorder in children

Acronym

rituximab for pediatric neurological disorder

Scientific Title

Efficacy and safety of rituximab for intractable immunogenic neurological disorder in children

Scientific Title:Acronym

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



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



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

1st name
Middle name
Last name Hiroaki Nagase

Organization

Kobe University Graduate School of Medicine

Division name

Department of Pediatrics

Zip code


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

1st name
Middle name
Last name Hiroaki Nagase

Organization

Kobe University Graduate School of Medicine

Division name

Department of Pediatrics

Zip code


Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe

TEL

078-382-6090

Homepage URL


Email

nagase@med.kobe-u.ac.jp


Sponsor or person

Institute

Department of Pediatrics, Kobe Universtiy Graduate School of Medicine

Institute

Department

Personal name



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)



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

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


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

Enrolling by invitation

Date of protocol fixation

2012 Year 06 Month 28 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009223


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name