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NCT04878211 · ClinicalTrials.gov registry record · Phase 4
A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
NCT04878211: Clinical Trial Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT04878211 is a Phase 4 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 24 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04878211, a Phase 4 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study evaluated if relapsing multiple sclerosis (MS) participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once monthly could develop an adequate immune response to the COVID-19 mRNA vaccine compared to participants on an interferon or glatiramer acetate.
Primary Outcome
An immune response is defined as a positive SARS-CoV-2 qualitative IgG antibody assay ≥14 days after full course \[2 doses\] vaccination to non live mRNA COVID-19 vaccine, Participants with a negative or borderline result were considered non-responders, as well as participants with a missing or invalid immune response assessment at 14 days post-vaccination (imputed as non-responders).
Interventions
- DRUG Ofatumumab
- BIOLOGICAL mRNA COVID-19 vaccine
- DRUG interferon or glatiramer acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-06-10 |
| Est. Completion | 2023-04-14 |
| Phase | Phase 4 |
Why NCT04878211 stopped before completion
NCT04878211 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Ofatumumab is the first listed.
NCT04878211 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04878211 about?
NCT04878211 is a clinical study titled "A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab". This study evaluated if relapsing multiple sclerosis (MS) participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once monthly could develop an adequate immune response to the COVID-19 mRNA vaccine compared to participants on an interferon or glatiramer acetate.
What is the current status of trial NCT04878211?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2021-06-10. Estimated completion is 2023-04-14.
What interventions are being tested in trial NCT04878211?
The interventions under investigation include: Ofatumumab (DRUG), mRNA COVID-19 vaccine (BIOLOGICAL), interferon or glatiramer acetate (DRUG).
Who is sponsoring clinical trial NCT04878211?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04878211's enrollment target sits among peer trials
24 1699th of 2000 higher than 276 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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