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This is a single arm, pilot multicenter prospective study in up to 22 participants with relapsing multiple sclerosis. Patients screened for the study can either be scheduled for vaccine, have received a single vaccine with a scheduled second dose, or already completed full course (two dose) vaccination. Fully vaccinated participants must be able to complete immune assay No.1 ≥ 14 days after the second dose of vaccine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| participants with RMS treated with ofatumumab | Relapsing MS participants receiving a full course (two doses) of a COVID-19 mRNA vaccine after starting ofatumumab 20 mg subcutaneous treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ofatumumab | Other | Prospective observational cohort study. There is no treatment allocation. Patients administered Ofatumumab by prescription that have started before inclusion of the patient into the study will be enrolled. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving immune response - immune assay No. 1 | Achieving immune response as defined by a positive SARS-CoV-2 qualitative IgG antibody assay. (yes/no) | 14 days after full course vaccination (two doses) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving immune response - immune assay No. 2 | Achieving immune response as defined by a positive SARS-CoV-2 qualitative IgG antibody assay 90 days after assay No. 1 (yes/no) | 90 days post assay 1 |
| Adverse events/serious adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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Relapsing MS participants receiving a full course (two doses) of a COVID-19 mRNA vaccine after starting ofatumumab 20 mg subcutaneous treatment
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Phoenix | Arizona | 85018 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37769429 | Derived | Bar-Or A, Aburashed R, Chinea AR, Hendin BA, Lucassen E, Meng X, Stankiewicz J, Tullman MJ, Cross AH. Humoral immune response to COVID-19 mRNA vaccines in patients with relapsing multiple sclerosis treated with ofatumumab. Mult Scler Relat Disord. 2023 Nov;79:104967. doi: 10.1016/j.msard.2023.104967. Epub 2023 Aug 28. |
| Label | URL |
|---|---|
| Results for COMB157GUS18 from the Novartis Clinical Trials Website | View source |
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| Covid-19 vaccine | Other | Prospective observational cohort study. There is no treatment allocation. Participants will obtain the COVID-19 FDA approved Emergency Use mRNA vaccine through their HCP (private insurance) or appropriate federal, state or local program. |
|
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. |
| 120 days after full course vaccination |
| Owosso |
| Michigan |
| 48867 |
| United States |
| Novartis Investigative Site | St Louis | Missouri | 63131 | United States |
| Novartis Investigative Site | Plainview | New York | 11803 | United States |
| Novartis Investigative Site | Guaynabo | 00968 | Puerto Rico |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C527517 | ofatumumab |
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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