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

Condition(s) studied

Investigational drug(s) / intervention(s)

UPLIZNA: Enrolled female participants with NMOSD who were exposed to UPLIZNA during pregnancy will be assessed. No study drug will be administered.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Number of newborns with Major Congenital Malformations (MCMs) — Minimum of 10 years
• Number of newborns with Preterm birth — Minimum of 10 years
• Number of newborns with low birth weight — Minimum of 10 years
• Number of stillbirths — Minimum of 10 years

Trial sites (1)