An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy
Amgen
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.
Description
Acquired from Horizon in 2024.
Eligibility
- Age range
- 15+ years
- Sex
- Female
- Healthy volunteers
- No
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
Interventions
- DrugUPLIZNA
Enrolled female participants with NMOSD who were exposed to UPLIZNA during pregnancy will be assessed. No study drug will be administered.
Location
- University of Colorado DenverAurora, Colorado