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).
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.
Interventions
13-valent pneumococcal conjugate vaccine (13-PCV)
23-valent pneumococcal polysaccharide vaccine (23-PPV)
Keyhole limpet hemocyanin (KLH) neo-antigen
Ofatumumab
Seasonal Quadrivalent influenza vaccine
Tetanus toxoid (TT) containing vaccine (Td, Tdap)
Eligibility Criteria
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
Josephson Wallack Munshower Neurology P.C
Recruiting
Indianapolis,Indiana,46256,United States
Craig Edward Herrman
Henry Ford Hospital
Recruiting
Detroit,Michigan,48202 2689,United States
Mirela Cerghet
Lonestar Neurology of San Antonio
Recruiting
San Antonio,Texas,78258,United States
Ann Bass
Jem Research Institute
Recruiting
Atlantis,Florida,33462-6608,United States
Mark Allen Goldstein
Neuro Medical Clinic of Cenla LLC
Recruiting
Alexandria,Louisiana,71301,United States
Ariel Antezana-Antezana
University of Tennessee Medical Center
Recruiting
Knoxville,Tennessee,37920,United States
Randall Trudell
Billings Clinic
Recruiting
Billings,Montana,59101,United States
Sara Qureshi
The Neuromedical Center
Recruiting
Baton Rouge,Louisiana,70810,United States
Jon Olson
University of Kansas Hospital
Recruiting
Kansas City,Kansas,66160,United States
Sharon Lynch
Texas Institute for Neurological Disorders
Recruiting
Sherman,Texas,75092,United States
Bharathy E. Sundaram
Neurology Offices of South Florida PLLC
Recruiting
Delray Beach,Florida,33445,United States
Brian Costell
University of Alabama at Birmingham
Recruiting
Birmingham,Alabama,35233-0271,United States
Khurram Bashir
Hope Neurology
Recruiting
Knoxville,Tennessee,37922,United States
Sibyl Wray
Cleveland Clinic Foundation
Recruiting
Cleveland,Ohio,44195,United States
Jeffrey Cohen
Wayne State University Multiple Sclerosis Clinic
Recruiting
Detroit,Michigan,48201,United States
Jacob Rube
College Park Family Care Center
Recruiting
Overland Park,Kansas,66210,United States
Jeffrey Kaplan
Rush University Medical Center
Recruiting
Chicago,Illinois,60612,United States
Thomas Shoemaker
Evergreen Health Multiple Sclerosis Center
Recruiting
Kirkland,Washington,98034,United States
Theodore Brown
North Central Neurology Associates PC
Recruiting
Cullman,Alabama,35058,United States
Christopher LaGanke
Neurology and Sleep Center
Recruiting
Lubbock,Texas,79410,United States
Bhupesh Dihenia
Wesley Neurology Clinic
Recruiting
Cordova,Tennessee,38018,United States
Kendrick K Henderson
Worldwide Contacts
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