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NCT05909761 · ClinicalTrials.gov registry record
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
A clinical trial of Pregnancy Related and Neuromyelitis Optica Spectrum Disorder, sponsored by Amgen.
- Recruiting
- Registry status
- 60
- Enrollment target
- 1
- Study location
NCT05909761 is a study of Pregnancy Related and Neuromyelitis Optica Spectrum Disorder that is actively recruiting participants, run by Amgen. The registered enrollment target is 60 participants, below the 1,962-participant average among 99 other Pregnancy Related trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05909761, a study of Pregnancy Related and Neuromyelitis Optica Spectrum Disorder, is actively recruiting participants, sponsored by Amgen.
- RECRUITING
- Registry status
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG UPLIZNA
Study Locations (1)
Colorado
- University of Colorado Denver - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-04-15 |
| Est. Completion | 2032-10-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05909761
The ClinicalTrials.gov registry entry for NCT05909761 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,962-participant average among 99 other Pregnancy Related trials with a reported enrollment target (97% lower). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pregnancy Related appearing as the primary indexed condition, and to 1 intervention - of which UPLIZNA is the first listed.
NCT05909761 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT05909761 about?
NCT05909761 is a clinical study titled "Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy". 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 c...
What is the current status of trial NCT05909761?
This trial is currently recruiting. The enrollment target is 60 participants. The study started on 2026-04-15. Estimated completion is 2032-10-31.
What conditions does trial NCT05909761 study?
This clinical trial studies the following conditions: Pregnancy Related, Neuromyelitis Optica Spectrum Disorder.
What interventions are being tested in trial NCT05909761?
The interventions under investigation include: UPLIZNA (DRUG).
Who is sponsoring clinical trial NCT05909761?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05909761 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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