UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062841 |
|---|---|
| Receipt number | R000071941 |
| Scientific Title | Relapse Rates, Treatment Patterns, and Adverse Events in Patients with Neuromyelitis Optica Spectrum Disorder: A Study Using a National Database |
| Date of disclosure of the study information | 2026/09/10 |
| Last modified on | 2026/09/07 18:45:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Relapse Rates, Treatment Patterns, and Adverse Events in Patients with Neuromyelitis Optica Spectrum Disorder: A Study Using a National Database
Acronym
NMOSD NDB Study
Scientific Title
Relapse Rates, Treatment Patterns, and Adverse Events in Patients with Neuromyelitis Optica Spectrum Disorder: A Study Using a National Database
Scientific Title:Acronym
NMOSD NDB Study
Region
| Japan |
Condition
Condition
Neuromyelitis optica spectrum disorder
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the relapse-free rate and the incidence of serious infections among patients with neuromyelitis optica spectrum disorder.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to onset of an attack or relapse in the biologic-treated and non biologic treated cohorts
Temporal trends in the incidence of infections requiring hospitalization
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who met the study definition of NMOSD during the study period
Key exclusion criteria
Patients who met the study definition of myelin oligodendrocyte glycoprotein antibody associated disease (MOGAD) within 180 days before the initial diagnosis date of NMOSD.
Patients who met the study definition of MOGAD or multiple sclerosis (MS) after the initial diagnosis date of NMOSD.
Target sample size
0
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Tsuboyama |
Organization
Chugai Pharmaceutical Co., Ltd.
Division name
Specialty Medical Science Dept.
Zip code
103-8324
Address
1-1 Nihonbashi-Muromachi 2-chome, Nihonbashi Mitsui Tower Chuo-ku, Tokyo
TEL
03-3281-6611
cma-clinicaltrial@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Urakawa |
Organization
Chugai Pharmaceutical Co., Ltd.
Division name
Specialty Medical Science Dept.
Zip code
103-8324
Address
1-1 Nihonbashi-Muromachi 2-chome, Nihonbashi Mitsui Tower Chuo-ku, Tokyo
TEL
03-3281-6611
Homepage URL
cma-clinicaltrial@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
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
Non-Profit Organization MINS Institutional Review Board
Address
5-20-9-401, Mita, Minato-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 10 | 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
| 2026 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 01 | Month | 31 | Day |
Other
Other related information
<Sponsor>
CHUGAI PHARMACEUTICAL CO., LTD.
< Statistical analysis vendor >
NTT DATA Japan Corporation
Management information
Registered date
| 2026 | Year | 09 | Month | 07 | Day |
Last modified on
| 2026 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071941
