Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

Running, not enrolling · Phase 3

Conditions studied: Relapsing Multiple Sclerosis

In brief

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). COVID-19 sub-study: The purpose of this research sub-study is to explore the immune response following Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination in a subset of subjects on long-term ofatumumab 20 mg sc. Note: Novartis is not supplying the SARS-CoV-2 vaccine.

Key facts

Study ID

NCT03650114

Run by

Novartis Pharmaceuticals

People needed

1882

Starts

2018-12-28

Expected to finish

2028-09-30

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• North Central Neurology Associates PC — Cullman, Alabama, United States
• Barrow Neurological Clinics at St Josephs Hospital and MC — Phoenix, Arizona, United States
• Fullerton Neuro and Headache Ctr — Fullerton, California, United States
• University of California Davis — Sacramento, California, United States
• CU Anschutz Med Campus — Aurora, Colorado, United States
• Mountain Neuro Research Center PC — Basalt, Colorado, United States
• Alpine Clinical Research Center — Boulder, Colorado, United States
• Colorado Springs Neurological Associates — Colorado Springs, Colorado, United States
• Colorado Neurological Research PC — Denver, Colorado, United States
• University of Colorado Health Neurology — Fort Collins, Colorado, United States
• Christiana Care Health Services — Newark, Delaware, United States
• Jem Research Institute — Atlantis, Florida, United States
• Neurology Offices of South Florida PLLC — Delray Beach, Florida, United States
• Infinity Clinical Research LLC — Hollywood, Florida, United States
• Homestead Assoc In Research Inc — Homestead, Florida, United States
• Neurology Associates PA — Maitland, Florida, United States
• UM Department Of Neurology — Miami, Florida, United States
• Aqualane Clinical Research — Naples, Florida, United States
• MS and Neuromuscular Center of Excellence — Oldsmar, Florida, United States
• Neurology Associates of Ormond Beach — Ormond Beach, Florida, United States
• Emerald Coast Neurology — Pensacola, Florida, United States
• Neurostudies Inc — Port Charlotte, Florida, United States
• Negroski Neurology — Sarasota, Florida, United States
• Roskamp Institute Inc — Sarasota, Florida, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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