Actively Recruiting
Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder Exposed to UPLIZNA During Pregnancy
Led by Amgen · Updated on 2026-01-27
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an observational study to monitor women with Neuromyelitis Optica Spectrum Disorder (NMOSD) who were exposed to UPLIZNA during pregnancy. The purpose is to collect detailed information on pregnancy outcomes and related factors in this group. This study spans at least 10 years to gather long-term safety data about UPLIZNA exposure during pregnancy or within six months before conception. Female participants with NMOSD who have received UPLIZNA at any time during pregnancy or within six months before conception will be observed. There is no administration of study drug during the trial. The schedule of medical visits and treatment routines will be determined by each participant's healthcare provider, allowing personalized care throughout the study. Participants will voluntarily report pregnancies and related data, which may include pregnancy outcomes and potential confounding factors. Researchers will monitor newborn health outcomes such as major and minor congenital malformations, preterm birth, low birth weight, stillbirths, developmental milestones, neurological and immune system abnormalities, and pregnancy loss over a minimum of 10 years. This extensive follow-up will help understand the safety profile of UPLIZNA exposure in pregnancy.
CONDITIONS
Brief Title
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent
- Are a female of reproductive potential with a confirmed or suspected diagnosis of NMOSD
- Have been exposed to UPLIZNA during pregnancy or within 6 months preceding conception
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 years
Participants who were exposed to UPLIZNA during pregnancy are observed for safety outcomes related to pregnancy and infant health.
Periodic visits or contacts over 10 years to assess newborn and infant health outcomes
Trial Site Locations
Total: 1 location
1
University of Colorado Denver
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
A
Amgen Call Center
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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