Phase 4
Completed N=63
A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab
Source: ClinicalTrials.gov NCT04667117 ↗Enrolled (actual)
63
Serious AEs
1.6%
Results posted
Aug 2024
Primary outcomePrimary: Percentage of Participants Achieving Seroprotection at Week 4 (Observed Case) — 100.00; 100.00; 100.00; 100.00 percentage of participants
◆ Published Evidence
Emerging
2citations · ~2 / year
Immune response to influenza vaccine in patients with relapsing multiple sclerosis treated with ofatumumab: Results from an open-label, multicenter, phase 4 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.
Linked Publications
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Immune response to influenza vaccine in patients with relapsing multiple sclerosis treated with ofatumumab: Results from an open-label, multicenter, phase 4 study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Seroprotection at Week 4 (Observed Case) |
100.00; 100.00; 100.00; 100.00; 80.00; 85.71 | — |
| PRIMARY Percentage of Participants Achieving Seroprotection at Week 4 (Non-responder Imputation) |
55.56; 66.67; 100.00; 86.67; 80.00; 66.67 | — |
| SECONDARY Percentage of Participants Achieving Seroconversion at Week 4 (Observed Case) |
80.00; 0.00; 0.00; 84.62; 20.00; 42.86 | — |
| SECONDARY Percentage of Participants Achieving Seroconversion at Week 4 (Non-responder Imputation) |
44.44; 0.00; 0.00; 73.33; 20.00; 33.33 | — |
| SECONDARY Fold Change From Baseline in Hemagglutination Inhibition Titers |
5.3; 1.4; 2.0; 9.4; 1.4; 2.9 | — |
| SECONDARY Number of Participants With Adverse Events (AEs), AEs Leading to Discontinuation and Serious Adverse Events (SAEs) |
16; 6; 2; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent must be obtained prior to participation in the study
- Age 18-55 years old
- Diagnosis of relapsing MS by 2017 revised McDonald criteria
- Must be willing to comply with the study schedule
- Planning to receive a 2020-2021, 2021-2022, or 2022-2023 inactivated influenza vaccine
- Planning to start treatment with ofatumumab or already on commercially prescribed ofatumumab for at least 2 weeks prior to the screening visit
Participants in Cohort 3 must fulfill criteria 1-5 above in addition to the following:
- Participant must currently be receiving iDMT
Exclusion Criteria
- Already has received the 2020-2021, 2021-2022, or 2022-2023 season influenza vaccine
- Known hypersensitivity to any component of the influenza vaccine
- Any safety finding including low IgG and/or low IgM levels requiring an ofatumumab treatment interruption within the 12 weeks immediately prior to Week 0
- Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to or oral antibiotics within two weeks prior to Week 0
- Known clinical diagnosis of influenza infection during the 2020-2021 influenza season prior to starting the study based on investigator's or subject's personal physician's judgement (laboratory report of confirmed influenza infection is not required)
- Prior treatment with B-cell targeted therapies (e.g., rituximab or ocrelizumab), lymphocyte-trafficking blockers, alemtuzumab, anti-CD4, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, bone marrow transplantation. Treatment with a natalizumab within 6 months of week 0
- Treatment with an S1P modulator within 60 days prior to Week 0
- Participants with any known active systemic bacterial, fungal or viral or fungal infections (such as hepatitis, progressive multifocal leukocencephalopathy, COVID-19 or HIV), or known to have acquired immunodeficiency syndrome (AIDS)
- Participation in another interventional clinical trial within 14 days prior to the screening visit
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
- Women of child-bearing potential
- Patients with a history of Guillain-Barre syndrome within 6 weeks of receiving the influenza vaccination.
Data sourced from ClinicalTrials.gov (NCT04667117) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.