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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: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT04998812 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 70 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The event rate (percentage of infants with B cell levels below LLN) and corresponding Clopper Pearson 95% CI were reported. B-cell reference ranges by week of life (absolute counts) are defined by Borriello et al. 2022.
Interventions
- DRUG Ocrelizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2022-04-13 |
| Est. Completion | 2025-07-14 |
| Phase | Phase 4 |
What the finished NCT04998812 record still lists
NCT04998812 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Ocrelizumab is the first listed.
NCT04998812 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04998812's enrollment target sits among peer trials
70 1043rd of 2000 higher than 931 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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