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Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
Sponsor: 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.
Official title: An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy
Key Details
Gender
FEMALE
Age Range
15 Years - Any
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2026-04-15
Completion Date
2032-10-31
Last Updated
2026-01-27
Healthy Volunteers
No
Interventions
UPLIZNA
Enrolled female participants with NMOSD who were exposed to UPLIZNA during pregnancy will be assessed. No study drug will be administered.
Locations (1)
University of Colorado Denver
Aurora, Colorado, United States