Multiple Sclerosis Clinical Trial
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.
Vaccinations against influenza are an important part of effective management of multiple sclerosis (MS).
Ofatumumab is a human anti-CD20 monoclonal antibody (mAb) which depletes B-cells, a component of the immune system. This study investigates if ofatumumab treated patients can have an immune response that may be protective after receiving the influenza vaccine.
There will be a one week screening period to assess eligibility for the trial. All eligible participants will receive an influenza vaccine during the Screening Period prior to the Investigational Period. This study will enroll 66 participants with relapsing multiple sclerosis into three cohorts in multiple centers. Up to 44 of the participants will begin treatment with ofatumumab or will already be receiving commercial ofatumumab. The remaining 22 participants will remain on their Injectable Disease Modifying Therapy (iDMT). There will be 4 weekly visits during the Investigational Period which will last 4 weeks. There will also be an optional, 6 month Extension Period for Cohorts 1 and 2, who received ofatumumab, to further evaluate immune response. Cohort 3 will not enter the Extension Period.
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
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.
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There are 4 Locations for this study
Phoenix Arizona, 85018, United States
Sunrise Florida, 33351, United States
Saint Louis Missouri, 63131, United States
Vienna Virginia, 22182, United States
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