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NCT04998812 · ClinicalTrials.gov registry record · Phase 4
A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 70
- Enrollment target
NCT04998812 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 70 participants.
The verdict
NCT04998812, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 70 participants
- Enrollment target
Study Summary
This study will evaluate the potential placental transfer of ocrelizumab in pregnant women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) \[in line with the locally approved indications\] whose last dose of ocrelizumab was administered any time from 6 months before the last menstrual period (LMP) through to the first trimester (up to gestational week 13) of pregnancy, and the corresponding pharmacodynamic effects (B cell levels) in the infant.
Interventions
- DRUG Ocrelizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2022-04-13 |
| Est. Completion | 2025-07-14 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04998812
The ClinicalTrials.gov registry entry for NCT04998812 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ocrelizumab is the first listed.
NCT04998812 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04998812 about?
NCT04998812 is a clinical study titled "A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy". This study will evaluate the potential placental transfer of ocrelizumab in pregnant women with clinically isolated syndrome (CIS) or multiple sclerosis (MS) \[in line with the locally approved indications\] whose last dose of ocrelizumab was administered any time from 6 months before the last menst...
What is the current status of trial NCT04998812?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 70 participants. The study started on 2022-04-13. Estimated completion is 2025-07-14.
What interventions are being tested in trial NCT04998812?
The interventions under investigation include: Ocrelizumab (DRUG).
Who is sponsoring clinical trial NCT04998812?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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