Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS
An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis
ClinicalTrials.gov Identifier: NCT03650114
Novartis Reference Number: COMB157G2399
Last Update: Jan 07, 2021
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
Study Description
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).
Interventions
Eligibility Criteria
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
Study Locations
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]