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

Recruiting
years of age
Female
Phase N/A
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

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

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

Study details

Neuromyelitis Optica Spectrum Disorder, Pregnancy Related

NCT05909761

Amgen

16 May 2024

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