A medical chart review evaluating pregnancy outcomes and infant safety in pregnant patients with neuromyelitis optica spectrum disorder (NMOSD) who were exposed to satralizumab

A medical chart review evaluating pregnancy outcomes and infant safety in pregnant patients with neuromyelitis optica spectrum disorder (NMOSD) who were exposed to satralizumab - SAkuraPreg study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060821

Enrollment

Registered

2026-03-06

Start date

2026-03-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromyelitis optica spectrum disorder

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: No exclusion criteria will be established in this study.

Design outcomes

Primary

Measure	Time frame
Pregnancy outcomes	—

Countries

Japan

Contacts

Public ContactSanae Sakamoto

Kyushu Studygroup of Clinical Cancer Clinical Research

sakamoto.sanae@ks-cc.org092-419-7260

Outcome results