UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050027 |
|---|---|
| Receipt number | R000056971 |
| Scientific Title | Effectiveness and safety of Satralizumab in Japan; Interleukin-6 receptor inhibition in Neuromyelitis Optica Spectrum Disorders, multicentre medical chart review |
| Date of disclosure of the study information | 2023/01/13 |
| Last modified on | 2023/07/25 13:24:11 |
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Basic information
Public title
Effectiveness and safety of Satralizumab in Japan; Interleukin-6 receptor inhibition in Neuromyelitis Optica Spectrum Disorders, multicentre medical chart review
Acronym
SAkuraBeyond
Scientific Title
Effectiveness and safety of Satralizumab in Japan; Interleukin-6 receptor inhibition in Neuromyelitis Optica Spectrum Disorders, multicentre medical chart review
Scientific Title:Acronym
SAkuraBeyond
Region
| Japan |
Condition
Condition
Neuromyelitis optica spectrum disorder
Classification by specialty
| Neurology | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe NMOSD relapse under satralizumab treatment in Japanese real world.
Basic objectives2
Others
Basic objectives -Others
Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Clinical measures related to disease activity through 26 weeks and 130 weeks after the start of treatment with satralizumab
- Annualized relapse rate
- Time to first relapse
- Proportion of relapse-free patients
2. Details of relapse
- Position of relapse
- Chief complaint of relapse
- Visual acuity at the time of relapse
- Content of acute treatment
- Proportion of hospitalization due to relapse
- Length of hospital stay at the time of relapse
- Proportion of patients who re-started satralizumab after relapse and time to restart
- Types and doses of concomitant medications at relapse
- Biologics started after relapse under satralizumab treatment
3. Dose of concomitant medication over time for the patient who had relapse during satralizumab treatment
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
| 7 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Have a diagnosis of neuromyelitis optica spectrum disorder (including neuromyelitis optica).
2) Have a diagnosis of AQP4 antibody seropositive prior to satralizumab initiation prior to administration of satralizumab, which can be confirmed in the medical record.
3) Started satralizumab after 26th August 2020 at our study site.
4) 7 years old or older at the start of satralizumab treatment.
5) Registered in the satralizumab post marketing surveillance (all-case survey).
6) Signed informed consent has been obtained from the patient or the legally acceptable representative to participate in the study. For patient aged 7-16 years, signed informed consent in writing if possible. Or, if it is difficult to obtain appropriate consent for reasons such as changing hospital at the time of screening in this study, medical institutions are provided with the opportunity to notify or disclose the use of information to research subjects and refuse it.
7) Satralizumab has been selected as the most appropriate medical care.
Key exclusion criteria
Any previous treatment with IL-6 inhibitory therapy except satralizumab.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Fujihara |
Organization
Southern TOHOKU Research Institute for Neuroscience
Division name
Multiple Sclerosis and Neuromyelitis Optica Center
Zip code
963-8563
Address
7-115 Yatsuyamada, Koriyama-City, Fukushima, Japan
TEL
024-934-5322
fujikazu@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Kubo |
Organization
EPS Corporation
Division name
Clinical Research Center, Real World Evidence Business Headquarters
Zip code
162-0814
Address
Acropolis TOKYO, 6-29 Shin-ogawamachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5804-5045
Homepage URL
prj-sakurabeyond@eps.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
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Southern TOHOKU General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Research Ethics Committee
Address
5-20-9-401,Mita,Minato-ku,Tokyo 108-0073
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
| 2023 | Year | 01 | Month | 13 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Sponsor>
CHUGAI PHARMACEUTICAL CO., LTD.
<Co-sponsor>
Southern TOHOKU General Hospital
<Contract Research Organization>
EPS Corporation
Management information
Registered date
| 2023 | Year | 01 | Month | 13 | Day |
Last modified on
| 2023 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056971
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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