SATRALIZUMAB SINGLE-ARM PREGNANCY SAFETY STUDY: A GLOBAL, OBSERVATIONAL, SINGLE-ARM, 10-YEAR STUDY OF PREGNANCY AND INFANT OUTCOMES IN SATRALIZUMAB-EXPOSED WOMEN WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER

SATRALIZUMAB SINGLE-ARM PREGNANCY SAFETY STUDY: A GLOBAL, OBSERVATIONAL, SINGLE-ARM, 10-YEAR STUDY OF PREGNANCY AND INFANT OUTCOMES IN SATRALIZUMAB-EXPOSED WOMEN WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER - NMO

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031718

Enrollment

Registered

2023-04-20

Start date

2023-05-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

G36.0

Interventions

Group 1: This global, observational, single-arm, 10-year study will collect and describe maternal, fetal and infant adverse outcomes among women with NMOSD exposed to satralizumab during the 6 months

Eligibility

Sex/Gender

Female

Age

12 Years to No maximum

Inclusion criteria

Inclusion criteria: Patient informed consent (written or verbal as per local regulations or Ethics Committee requirements) obtained prior to enrollment. Where applicable, consent must be obtained from the patient’s parent, guardian, or legally authorized representative, and the patient should provide assent per local and national requirements. Consent will be obtained in compliance with any country or region specific regulations and requirements. Ability to comply with the study protocol. Diagnosed with AQP4 antibody seropositive NMOSD. Prospective or retrospective pregnancy with documented exposure to satralizumab during the 6 months prior to the LMP or at any time during the pregnancy.

Exclusion criteria

Exclusion criteria: There are no exclusion criteria for this study.

Design outcomes

Primary

Measure	Time frame
To collect and describe maternal, fetal and infant adverse outcomes among women with neuromyelitis optica spectrum disorder (NMOSD) exposed to satralizumab during the 6 months prior to the last menstrual period (LMP) or at any time during pregnancy. To observe and report selected adverse pregnancy and birth outcomes (i.e., spontaneous abortions, fetal deaths/stillbirths, elective terminations, and preterm births) and pregnancy complications in women with NMOSD exposed to satralizumab during the defined exposure window.	—

Measure

Time frame

To collect and describe maternal, fetal and infant adverse outcomes among women with neuromyelitis optica spectrum disorder (NMOSD) exposed to satralizumab during the 6 months prior to the last menstrual period (LMP) or at any time during pregnancy. To observe and report selected adverse pregnancy and birth outcomes (i.e., spontaneous abortions, fetal deaths/stillbirths, elective terminations, and preterm births) and pregnancy complications in women with NMOSD exposed to satralizumab during the defined exposure window.

—

Secondary

Measure	Time frame
To observe and report selected adverse fetal/neonatal/infant outcomes (i.e., major and minor congenital malformations, small for gestational age, postnatal growth and development) at birth and through the first year of life of infants from pregnancies in women with NMOSD exposed to satralizumab during the defined exposure window.	—

Countries

France, Germany, Italy

Contacts

Public ContactKerstin Hellwig

Katholisches Klinikum Bochum gGmbH

Kerstin.Hellwig@ruhr-uni-bochum.de+49 234 509-3923

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026