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
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
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
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
