Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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).
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
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