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NCT05909761
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
Conditions: Neuromyelitis Optica Spectrum Disorder, Pregnancy Related
Sex: Female
Ages: 15 Years – N/A
Healthy volunteers: No
Enrollment: 60
Sponsor: Amgen
Location: University of Colorado Denver Aurora Colorado
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 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
Source: ClinicalTrials.gov (NCT05909761). StuddyBuddy aggregates publicly available trial information.