UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051988 |
|---|---|
| Receipt number | R000059331 |
| Scientific Title | Neuromyelitis optica spectrum disorder Registry (Japan Neuroimmune Disease Registry) |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2024/08/26 10:53:36 |
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Basic information
Public title
Neuromyelitis optica spectrum disorder Registry (Japan Neuroimmune Disease Registry)
Acronym
JANIMA
Scientific Title
Neuromyelitis optica spectrum disorder Registry (Japan Neuroimmune Disease Registry)
Scientific Title:Acronym
JANIMA
Region
| Japan |
Condition
Condition
Neuroimmune Disease (Neuromyelitis Optica Spectrum Disorders, MOG antibody-associated disease)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We will clarify the natural history and prognostic factors of NMOSD and MOGAD by accumulating and reviewing clinical information over a long period of time.
Basic objectives2
Others
Basic objectives -Others
We will establish a system to enable efficient recruitment of patients for clinical trials. This will contribute to the development and establishment of new treatment methods for NMOSD and MOGAD in the future.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The course of clinical endpoints mainly used for each neuroimmune disease.
Key secondary outcomes
1. Severity (EDSS, Functional Score, mRS)
2. Presence or absence of recurrence and timing
3. Cerebrospinal fluid findings, imaging (MRI) findings
4. Treatment history
5. Adverse events
6. EQ-5D-5L survey
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
As follows:
Neuromyelitis Optica Spectrum Disorder (NMOSD)
1) Patients who meet the Wingerchuk 2015 criteria (International Panel criteria)
2) Patients who have given written consent to participate in the study
Anti-myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD)
1) Patients who meet the International Panel 2023 criteria
2) Patients who have given written consent to participate in the study
Key exclusion criteria
Patients deemed inappropriate for inclusion by the investigator.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Nakashima |
Organization
School of Medicine, Tohoku Medical and Pharmaceutical University
Division name
Division of Neurology, Professor
Zip code
9838536
Address
1-15-1 Fukumuro, Miyagino-ku, Sendai, Miyagi Prefecture
TEL
0222908850
nakashima@tohoku-mpu.ac.jp
Public contact
Name of contact person
| 1st name | Juichi |
| Middle name | |
| Last name | Fujimori |
Organization
School of Medicine, Tohoku Medical and Pharmaceutical University
Division name
Division of Neurology, Associate Professor
Zip code
9838536
Address
1-15-1 Fukumuro, Miyagino-ku, Sendai, Miyagi Prefecture
TEL
0222908850
Homepage URL
https://www.janima.org
info@janima.org
Sponsor or person
Institute
The Japanese Society for Neuroimmunology
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
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
| 2023 | Year | 12 | Month | 01 | 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
| 2023 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2043 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Personal information, management information, background information, complications, severity at registration, relapse frequency, autoantibody information, cerebrospinal fluid findings, MRI findings, details of treatment
Management information
Registered date
| 2023 | Year | 08 | Month | 23 | Day |
Last modified on
| 2024 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059331
