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Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05909761). StuddyBuddy aggregates publicly available trial information.