Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy

Amgen

Status: Enrolling

Conditions: Pregnancy Related; Neuromyelitis Optica Spectrum Disorder

Treatments: Drug: UPLIZNA

Study type: Observational

Funder types: Industry

Identifiers

NCT05909761

VIB0551.P4.S4

EUPAS105613 (Other Identifier)

Details and patient eligibility

About

This is an observational study to monitor female participants exposed to UPLIZNA during pregnancy. This study requires voluntary reporting of pregnancies in female participants with NMOSD exposed to UPLIZNA during pregnancy or within 6 months preceding conception. Pregnancy-related data, potential confounding factors and information related to pregnancy outcome will be collected. The schedule of office visits and all treatment regimens will be determined by the treating healthcare provider. Duration of the study is 10 years, at minimum.

Full description

Acquired from Horizon in 2024.

Enrollment: 60 estimated patients

Sex: Female

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Provide informed consent
• Are a female of reproductive potential with a confirmed or suspected diagnosis of NMOSD
• Have been exposed to UPLIZNA during pregnancy as defined by receipt of any dose during pregnancy or within 6 months preceding conception

Note: Other Protocol Defined Inclusion/Exclusion Criteria Apply