ALITHIOS · COMB157G2399

Extension research aimed at long-term monitoring of patients with relapsing multiple sclerosis treated with ofatumumab. This study observes the drug's evolution regarding its safety and tolerability in an open-label clinical setting.

An open-label, single-arm, multicenter extension study evaluating the long-term safety, tolerability, and efficacy of ofatumumab in patients with relapsing multiple sclerosis. EudraCT: 2017-004703-51.

Sponsor: NOVARTIS

Phase: III

Status: Follow-up

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Public study eligibility criteria

Inclusion

  • 1. Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
  • 2. Written informed consent

Exclusion

  • * 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

  • 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

  • * 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