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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Amgen
Study ID
NCT05909761
Status
Recruiting
Apply to this trial

Conditions

  • Neuromyelitis Optica Spectrum Disorder
  • Pregnancy Related

Eligibility Criteria

Sex
FEMALE
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • UPLIZNA — DRUG
    Enrolled female participants with NMOSD who were exposed to UPLIZNA during pregnancy will be assessed. No study drug will be administered.

Study Details

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.

Key Dates

Start date
Apr 15, 2026
Status verified
Jan 2026
Primary completion
Oct 31, 2032
Completion
Oct 31, 2032

Study Design

Enrollment
60 participants (estimated)

Primary Outcome Measure

Number of newborns with Major Congenital Malformations (MCMs) [ Time Frame: Minimum of 10 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado DenverAuroraColorado80045
Amanda Piquet, MD
[email protected]
303-724-4319
Dr. Amanda Piquet, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
University of Colorado Denver· Aurora, CO

Related Studies