Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

To take part in the main study, you must have previously completed a specific Novartis MS study where you received ofatumumab. You also need to fully understand and agree to participate by giving your written consent.

However, you won't be able to join if you developed any significant health issues during your previous ofatumumab study that might put your safety at risk in this new study. Also, if you have active serious infections (like bacterial, viral, or fungal infections), or a long-lasting infection like AIDS, you cannot join. Taking specific medications that are not allowed by the study rules, or if you are pregnant or breastfeeding, would also prevent you from participating.

For the vaccine sub-study, you need to already be in the main study and have been on ofatumumab for at least 12 weeks continuously. You also can't have a known severe allergy or reaction to vaccines, or allergies to eggs or shellfish. If you've had certain safety issues, like very low levels of specific immune protecting proteins (IgG/IgM) that led to stopping ofatumumab, or a major infection requiring a hospital stay or strong intravenous antibiotics recently, you wouldn't be able to take part in the vaccine sub-study.

If you join the main study, you'll be followed for a long time to see how you respond to ofatumumab. The study will collect information on your health, how well you're tolerating the treatment, and if it's still working for your MS. This will involve regular visits to the clinic for check-ups and assessments, though the exact number of visits isn't detailed here.

If you also join the vaccine sub-study, you'll receive several standard vaccines, including those for tetanus, diphtheria, whooping cough, pneumonia, and the seasonal flu. The study team will then check your blood to see how your body's immune system reacts to these vaccines and how much protection you build up. You may also receive a 'neo-antigen' called KLH, which is a harmless substance used to test your general immune response. These parts of the study will involve additional visits and blood tests.

For the COVID-19 sub-study, data will be collected if you have already had your COVID-19 vaccines from your regular healthcare provider, to see how your body responded while on ofatumumab. You'll continue to receive your regular dose of ofatumumab throughout the study. The total duration of your participation isn't specified but will be long-term, as it's designed to collect ongoing information.