Overview
The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study.
Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).
Eligibility
Inclusion Criteria:
- Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
- Written informed consent
Exclusion Criteria:
- Emergence of any clinically significant condition/disease during the previous ofatumumab study in which study participation might result in safety risk for the subject
- Subjects with active systemic bacterial, viral or fingal infections, or chronic infection (e.g. AIDS)
- Subjects taking medications prohibited by the protocol
- Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply
Vaccination sub-study:
Inclusion criteria
- Informed consent
- Actively enrolled in the COMB157G2399 Study
- 12 weeks of continuous treatment within the COMB157G2399 Study
- prior vaccination history as per protocol-defined
Exclusion criteria
- known hypersensitivity or history of systemic allergic, neurologic or other reactions to vaccines
- allergies to egg or shellfish
- any safety findings including low IgG/IgM requiring ofatumumab interruption within 12 weeks prior to vaccination sub-study start
- any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks of the first vaccination sub-study visit
Other protocol-defined inclusion/exclusion criteria may apply