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An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis


Brief Summary:

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).


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

– 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


  • Novartis Investigative Site, Fullerton, California, United States, 92835
  • Novartis Investigative Site, Sacramento, California, United States, 95817
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