UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060821 |
|---|---|
| Receipt number | R000069513 |
| Scientific Title | A medical chart review evaluating pregnancy outcomes and infant safety in pregnant patients with neuromyelitis optica spectrum disorder (NMOSD) who were exposed to satralizumab |
| Date of disclosure of the study information | 2026/03/06 |
| Last modified on | 2026/03/04 18:04:28 |
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Basic information
Public title
A medical chart review evaluating pregnancy outcomes and infant safety in pregnant patients with neuromyelitis optica spectrum disorder (NMOSD) who were exposed to satralizumab
Acronym
SAkuraPreg study
Scientific Title
A medical chart review evaluating pregnancy outcomes and infant safety in pregnant patients with neuromyelitis optica spectrum disorder (NMOSD) who were exposed to satralizumab
Scientific Title:Acronym
SAkuraPreg study
Region
| Japan |
Condition
Condition
Neuromyelitis optica spectrum disorder
Classification by specialty
| Neurology | Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of satralizumab on pregnancy outcomes in patients with neuromyelitis optica spectrum disorder (NMOSD)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pregnancy outcomes
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
Female
Key inclusion criteria
1.Patients who have been fully informed about the study and have provided voluntary written informed consent
2.Patients diagnosed with aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD)
3.Patients who received satralizumab within 6 months prior to the last menstrual period (LMP) or during pregnancy
4.Patients for whom the pregnancy outcome is known as of March 31, 2026. In cases of live birth, the infant is older than 1 year as of June 30, 2026; however, cases in which the infant died before reaching 1 year of age are eligible
Key exclusion criteria
No exclusion criteria will be established in this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Katsuhisa |
| Middle name | |
| Last name | Yamashita |
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 (Reception15F) Chuo-ku, Tokyo
TEL
03-3281-6611
cma-clinicaltrial@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Sanae |
| Middle name | |
| Last name | Sakamoto |
Organization
Kyushu Studygroup of Clinical Cancer
Division name
Clinical Research
Zip code
812-0011
Address
3-4-25 Hakata Ekimae, Hakata-ku, Fukuoka
TEL
092-419-7260
Homepage URL
sakamoto.sanae@ks-cc.org
Sponsor or person
Institute
Chugai Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
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 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
| 2026 | Year | 03 | Month | 06 | 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
| 2025 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2026 | 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.
[Statistical Analysis Agency]
Medical Edge Co., Ltd.
[Medical Professionals]
Department of Medical Safety and Department of Neurology, Tokyo Women's Medical University
Yuko Shimizu
Japan Drug Information Institute in Pregnancy, Integrated Center for Women's Health, National Center for Child Health and Development
Mikako Goto
[Research Advisor]
Medical Education Center, Niigata University School of Medicine; Department of Neurology, Brain Research Institute, Niigata University
Izumi Kawachi
Department of Neurology, Graduate School of Medicine, Chiba University
Akiyuki Uzawa
Management information
Registered date
| 2026 | Year | 03 | Month | 04 | Day |
Last modified on
| 2026 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069513
