Offenarmige Studie zur Langzeit-Sicherheit, -Verträglichkeit und Effektivität von Ofatumumab in Patienten mit schubförmiger multipler Sklerose

Biological: Ofatumumab;Biological: Tetanus toxoid (TT) containing vaccine (Td, Tdap);Biological: 13-valent pneumococcal conjugate vaccine (13-PCV);Biological: 23-valent pneumococcal polysaccharide vaccine (23-PPV);Biological: Seasonal Quadrivalent influenza vaccine;Biological: Keyhole limpet hemocyanin (KLH) neo-antigen

Gender: All
Maximum age: 100 Years
Minimum age: 18 Years

Inclusion Criteria:

1. Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every
4 weeks

2. 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

1. Informed consent

2. Actively enrolled in the COMB157G2399 Study

3. 12 weeks of continuous treatment within the COMB157G2399 Study

4. 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