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
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
Study Location
University of Miami Miller School of Medicine
Recruiting
Miami,Florida,33136,United States
Silvia R Delgado
Hawaii Pacific Neuroscience LLC
Recruiting
Honolulu,Hawaii,96817,United States
Kore Liow
Barrow Neurological Clinics at St Josephs Hospital and MC
Recruiting
Phoenix,Arizona,85013,United States
Aimee Borazanci
MS and Neuromuscular Center of Excellence
Recruiting
Oldsmar,Florida,34677,United States
Jean-Raphael Schneider
Emerald Coast Neurology
Recruiting
Pensacola,Florida,32514,United States
David Bear
University of Alabama at Birmingham
Recruiting
Birmingham,Alabama,35233-0271,United States
Khurram Bashir
North Cntrl Neurology Associates PC
Recruiting
Cullman,Alabama,35058,United States
Christopher LaGanke
Wayne Stat Uni Multi Sclerosis Clnc
Recruiting
Detroit,Michigan,48201,United States
Evanthia Bernitsas
AMO Corporation
Recruiting
Tallahassee,Florida,32312,United States
Ricardo Ayala
Infinity Clinical Research LLC
Recruiting
Hollywood,Florida,33024,United States
Barry Cutler
College Park Family Care Center
Recruiting
Overland Park,Kansas,66210,United States
Jeffrey Kaplan
Neurology Associates, PA
Recruiting
Maitland,Florida,32751,United States
William David Honeycutt
University Of South Florida
Recruiting
Tampa,Florida,33612,United States
Derrick Robertson
Bradenton Research Center inc
Recruiting
Bradenton,Florida,34205,United States
Eric Folkens
University of California Davis
Recruiting
Sacramento,California,95817,United States
Michelle Apperson
Jem Research Institute
Recruiting
Atlantis,Florida,33462-6608,United States
Mark Goldstein
Aqualane Clinical Research
Recruiting
Naples,Florida,34102,United States
Matthew J Baker
Rush University Medical Center
Recruiting
Chicago,Illinois,60612,United States
Thomas Shoemaker
Henry Ford Hospital Main Centre
Recruiting
Detroit,Michigan,48202 2689,United States
Mirela Cerghet
Fullerton Neuro and Headache Ctr
Recruiting
Fullerton,California,92835,United States
Jack H Florin
Premiere Research Institute
Recruiting
West Palm Beach,Florida,33407,United States
Paul K. Winner
Neurology Offices of South Florida PLLC CBAF312A2304
Recruiting
Delray Beach,Florida,33445,United States
Brian Costell
Colorado Springs Neurological Associates .
Recruiting
Colorado Springs,Colorado,80907,United States
Kimberly Wagner
Velocity Clinical Research
Recruiting
Savannah,Georgia,31406,United States
J Michael Hemphill
Neuro Medical Clinic of Cenla LLC COMB157G2301
Recruiting
Alexandria,Louisiana,71301,United States
Ariel Antezana-Antezana
Christiana Care Health Services
Recruiting
Newark,Delaware,19713,United States
Jason M Silversteen
University of Kansas Medical Center .
Recruiting
Kansas City,Kansas,66160-7330,United States
Sharon Lynch
Josephson Wallack Munshower Neurology P.C
Recruiting
Indianapolis,Indiana,46256,United States
Craig Edward Herrman
Axiom Clinical Research of Florida
Recruiting
Tampa,Florida,33609,United States
Mark Cascione
The Neuromedical Center
Recruiting
Baton Rouge,Louisiana,70810,United States
Jon Olson
Homestead Associates in Research Inc
Recruiting
Miami,Florida,33032,United States
Angel Carrasco
Alpine Clinical Research Center
Recruiting
Boulder,Colorado,80301,United States
Paul Brownstone
Georgia Neurology and Sleep Medicine Assoc
Recruiting
Suwanee,Georgia,30024,United States
David Lesch
Neurostudies Inc
Recruiting
Port Charlotte,Florida,33952,United States
Liliana Montoya
CU Anschutz Med Campus
Recruiting
Aurora,Colorado,80045,United States
Enrique Alvarez
WA Uni School Of Med
Recruiting
Saint Louis,Missouri,63110,United States
Robert Naismith
Neurology Associates of Ormond Beach
Recruiting
Ormond Beach,Florida,32174,United States
James Scott
Clinical Research Of West FL Inc
Recruiting
Tampa,Florida,33603,United States
Lon D. Lynn
Worldwide Contacts
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