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NCT04667117 · ClinicalTrials.gov registry record · Phase 4
A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 63
- Enrollment target
NCT04667117: Completed Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT04667117 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 63 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04667117, a Phase 4 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 63 participants
- Enrollment target
Study Summary
To assess whether participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once every 4 weeks (q4) can mount an adequate immune response to inactivated influenza vaccine as measured by humoral responses compared to participants on an iDMT.
Primary Outcome
A seroprotection responder was a participant achieving seroprotection as defined by a post-vaccination hemagglutination inhibition (HI) titer ≥ 40 at Week 4. Seroprotection against ten influenza strains was analyzed. The analysis was performed taking into consideration observed data.
Interventions
- DRUG Ofatumumab
- BIOLOGICAL Quadrivalent influenza vaccine
- DRUG iDMT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2021-01-14 |
| Est. Completion | 2023-07-06 |
| Phase | Phase 4 |
What the finished NCT04667117 record still lists
NCT04667117 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which Ofatumumab is the first listed.
NCT04667117 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04667117 about?
NCT04667117 is a clinical study titled "A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab". To assess whether participants treated with ofatumumab 20 mg subcutaneous (s.c.) administered once every 4 weeks (q4) can mount an adequate immune response to inactivated influenza vaccine as measured by humoral responses compared to participants on an iDMT.
What is the current status of trial NCT04667117?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 63 participants. The study started on 2021-01-14. Estimated completion is 2023-07-06.
What interventions are being tested in trial NCT04667117?
The interventions under investigation include: Ofatumumab (DRUG), Quadrivalent influenza vaccine (BIOLOGICAL), iDMT (DRUG).
Who is sponsoring clinical trial NCT04667117?
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 NCT04667117's enrollment target sits among peer trials
63 1106th of 2000 higher than 891 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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