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:
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 Location
Novartis Investigative Site
Recruiting
Sofia,1413,Bulgaria
Novartis Investigative Site
Recruiting
Sofia,1113,Bulgaria
Novartis Investigative Site
Recruiting
Pleven,5800,Bulgaria
Novartis Investigative Site
Recruiting
Havirov,Czech Republic,736 01,Czech Republic
Novartis Investigative Site
Recruiting
Brno,Czech Republic,656 91,Czech Republic
Novartis Investigative Site
Recruiting
Hradec Kralove,CZE,500 05,Czech Republic
Novartis Investigative Site
Recruiting
Teplice,Czech Republic,415 01,Czech Republic
Novartis Investigative Site
Recruiting
Ostrava Poruba,708 52,Czech Republic
Novartis Investigative Site
Recruiting
Paris 13,75651,France
Novartis Investigative Site
Recruiting
Lille Cedex,59037,France
Novartis Investigative Site
Recruiting
Nice,Cedex1,06001,France
Novartis Investigative Site
Recruiting
Strasbourg,67000,France
Novartis Investigative Site
Recruiting
Nantes Cedex 1,44093,France
Novartis Investigative Site
Recruiting
Thessaloniki,GR 54636,Greece
Novartis Investigative Site
Recruiting
Pecs,7623,Hungary
Novartis Investigative Site
Recruiting
Budapest,HUN,1135,Hungary
Novartis Investigative Site
Recruiting
Budapest,HUN,1138,Hungary
Novartis Investigative Site
Recruiting
Budapest,HUN,1204,Hungary
Novartis Investigative Site
Recruiting
Rzeszow,35 055,Poland
Novartis Investigative Site
Recruiting
Kielce,25 726,Poland
Novartis Investigative Site
Recruiting
Katowice,40 571,Poland
Novartis Investigative Site
Recruiting
Warszawa,02 957,Poland
Novartis Investigative Site
Recruiting
Bydgoszcz,Woj Kujawsko-pomorskie,85-796,Poland
Novartis Investigative Site
Recruiting
Santa Maria da Feira,4520 211,Portugal
Novartis Investigative Site
Recruiting
Braga,4710243,Portugal
Novartis Investigative Site
Recruiting
Coimbra,3000 075,Portugal
Novartis Investigative Site
Recruiting
Novosibirsk,630007,Russian Federation
Novartis Investigative Site
Recruiting
Ekaterinburg,620109,Russian Federation
Novartis Investigative Site
Recruiting
Novosibirsk,630087,Russian Federation
Novartis Investigative Site
Recruiting
St Petersburg,190000,Russian Federation
Novartis Investigative Site
Recruiting
St. Petersburg,197376,Russian Federation
Novartis Investigative Site
Recruiting
Tyumen,625000,Russian Federation
Novartis Investigative Site
Recruiting
Sestroretsk,197706,Russian Federation
Novartis Investigative Site
Recruiting
Moscow,125367,Russian Federation
Novartis Investigative Site
Recruiting
Saint Petersburg,194044,Russian Federation
Novartis Investigative Site
Recruiting
Nizhny Novgorod,603137,Russian Federation
Novartis Investigative Site
Recruiting
Kazan,420043,Russian Federation
Novartis Investigative Site
Recruiting
Moscow,127015,Russian Federation
Novartis Investigative Site
Recruiting
Saransk,430032,Russian Federation
Novartis Investigative Site
Recruiting
Saint Petersburg,197022,Russian Federation
Novartis Investigative Site
Recruiting
Krasnoyarsk,660049,Russian Federation
Novartis Investigative Site
Recruiting
Nizhny Novgorod,603155,Russian Federation
Novartis Investigative Site
Recruiting
Kemerovo,650066,Russian Federation
Novartis Investigative Site
Recruiting
Martin,036 59,Slovakia
Novartis Investigative Site
Recruiting
Banska Bystrica,975 17,Slovakia
Novartis Investigative Site
Recruiting
Bratislava,83305,Slovakia
Novartis Investigative Site
Recruiting
Trnava,917 75,Slovakia
Novartis Investigative Site
Recruiting
Nitra,94901,Slovakia
Novartis Investigative Site
Recruiting
Bratislava,813 69,Slovakia
Novartis Investigative Site
Recruiting
Bratislava,82606,Slovakia
Novartis Investigative Site
Recruiting
Pretoria,0041,South Africa
Novartis Investigative Site
Recruiting
Rosebank,2196,South Africa
Novartis Investigative Site
Recruiting
Cadiz,Andalucia,11009,Spain
Novartis Investigative Site
Recruiting
Madrid,28006,Spain
Novartis Investigative Site
Recruiting
Castilleja De La Cuesta,Sevilla,41950,Spain
Novartis Investigative Site
Recruiting
El Palmar,Murcia,30120,Spain
Novartis Investigative Site
Recruiting
Madrid,28034,Spain
Novartis Investigative Site
Recruiting
Baracaldo,Vizcaya,48903,Spain
Novartis Investigative Site
Recruiting
San Sebastian,Pais Vasco,20080,Spain
Novartis Investigative Site
Recruiting
Barcelona,Cataluna,08026,Spain
Novartis Investigative Site
Recruiting
Pozuelo de Alarcon,Madrid,28223,Spain
Novartis Investigative Site
Recruiting
Madrid,28040,Spain
Novartis Investigative Site
Recruiting
Hospitalet de Llobregat,Barcelona,08907,Spain
Novartis Investigative Site
Recruiting
Madrid,28222,Spain
Novartis Investigative Site
Recruiting
Barcelona,Catalunya,08035,Spain
Novartis Investigative Site
Recruiting
Valencia,46026,Spain
Novartis Investigative Site
Recruiting
Sevilla,Andalucia,41009,Spain
Novartis Investigative Site
Recruiting
Barcelona,Catalunya,08036,Spain
Novartis Investigative Site
Recruiting
Malaga,Andalucia,29010,Spain
Novartis Investigative Site
Recruiting
Salt,Cataluna,17190,Spain
Novartis Investigative Site
Recruiting
Trabzon,61080,Turkey
Novartis Investigative Site
Recruiting
Samsun,55139,Turkey
Novartis Investigative Site
Recruiting
Izmir,35040,Turkey
Novartis Investigative Site
Recruiting
Izmir,35575,Turkey
Novartis Investigative Site
Recruiting
Sancaktepe,Istanbul,34785,Turkey
Novartis Investigative Site
Recruiting
Istanbul,TUR,34098,Turkey
Novartis Investigative Site
Recruiting
Headington,Oxfordshire,OX3 9DU,United Kingdom
Novartis Investigative Site
Recruiting
London,E1 1BB,United Kingdom
Novartis Investigative Site
Recruiting
London,SW17 0QT,United Kingdom
Novartis Investigative Site
Recruiting
Glasgow,G51 4TF,United Kingdom
Novartis Investigative Site
Recruiting
Luton,Beds,LU4 0DZ,United Kingdom
Novartis Investigative Site
Recruiting
Overland Park,Kansas,66210,United States
Novartis Investigative Site
Recruiting
Tacoma,Washington,98405,United States
Novartis Investigative Site
Recruiting
Colorado Springs,Colorado,80907,United States
Novartis Investigative Site
Recruiting
Las Vegas,Nevada,89106,United States
Novartis Investigative Site
Recruiting
West Palm Beach,Florida,33407,United States
Novartis Investigative Site
Recruiting
Billings,Montana,59101,United States
Novartis Investigative Site
Recruiting
Port Charlotte,Florida,33952,United States
Novartis Investigative Site
Recruiting
Naples,Florida,34102,United States
Novartis Investigative Site
Recruiting
Sarasota,Florida,34243,United States
Novartis Investigative Site
Recruiting
Tallahassee,Florida,32312,United States
Novartis Investigative Site
Recruiting
Columbus,Ohio,43214,United States
Novartis Investigative Site
Recruiting
Sacramento,California,95817,United States
Novartis Investigative Site
Recruiting
Willow Grove,Pennsylvania,19090,United States
Novartis Investigative Site
Recruiting
Miami,Florida,33032,United States
Novartis Investigative Site
Recruiting
San Antonio,Texas,78258,United States
Novartis Investigative Site
Recruiting
Birmingham,Alabama,35233-0271,United States
Novartis Investigative Site
Recruiting
Portland,Oregon,97225,United States
Novartis Investigative Site
Recruiting
Newark,Delaware,19713,United States
Novartis Investigative Site
Recruiting
Savannah,Georgia,31406,United States
Novartis Investigative Site
Recruiting
Albuquerque,New Mexico,87131-0001,United States
Novartis Investigative Site
Recruiting
Tampa,Florida,33603,United States
Novartis Investigative Site
Recruiting
Cordova,Tennessee,38018,United States
Novartis Investigative Site
Recruiting
Saint Louis,Missouri,63110,United States
Novartis Investigative Site
Recruiting
Honolulu,Hawaii,96817,United States
Novartis Investigative Site
Recruiting
Miami,Florida,33136,United States
Novartis Investigative Site
Recruiting
Boulder,Colorado,80301,United States
Novartis Investigative Site
Recruiting
Kirkland,Washington,98034,United States
Novartis Investigative Site
Recruiting
Oklahoma City,Oklahoma,73104,United States
Novartis Investigative Site
Recruiting
Charlotte,North Carolina,28204,United States
Novartis Investigative Site
Recruiting
El Paso,Texas,79935,United States
Novartis Investigative Site
Recruiting
Kansas City,Kansas,66160-7330,United States
Novartis Investigative Site
Recruiting
Alexandria,Louisiana,71301,United States
Novartis Investigative Site
Recruiting
Pensacola,Florida,32514,United States
Novartis Investigative Site
Recruiting
Tampa,Florida,33609,United States
Novartis Investigative Site
Recruiting
Cullman,Alabama,35058,United States
Novartis Investigative Site
Recruiting
Bradenton,Florida,34205,United States
Novartis Investigative Site
Recruiting
Saint Louis,Missouri,63141,United States
Novartis Investigative Site
Recruiting
Milwaukee,Wisconsin,53215,United States
Novartis Investigative Site
Recruiting
Knoxville,Tennessee,37920,United States
Novartis Investigative Site
Recruiting
Oldsmar,Florida,34677,United States
Novartis Investigative Site
Recruiting
Chicago,Illinois,60612,United States
Novartis Investigative Site
Recruiting
Fullerton,California,92835,United States
Novartis Investigative Site
Recruiting
Lubbock,Texas,79410,United States
Novartis Investigative Site
Recruiting
Asheville,North Carolina,28806,United States
Novartis Investigative Site
Recruiting
Philadelphia,Pennsylvania,19107-5098,United States
Novartis Investigative Site
Recruiting
Tampa,Florida,33612,United States
Novartis Investigative Site
Recruiting
Delray Beach,Florida,33445,United States
Novartis Investigative Site
Recruiting
Cleveland,Ohio,44195,United States
Novartis Investigative Site
Recruiting
Knoxville,Tennessee,37922,United States
Novartis Investigative Site
Recruiting
Ormond Beach,Florida,32174,United States
Novartis Investigative Site
Recruiting
Sunrise,Florida,33351,United States
Novartis Investigative Site
Recruiting
Maitland,Florida,32751,United States
Novartis Investigative Site
Recruiting
Raleigh,North Carolina,27607,United States
Novartis Investigative Site
Recruiting
Virginia Beach,Virginia,23456,United States
Novartis Investigative Site
Recruiting
Sherman,Texas,75092,United States
Novartis Investigative Site
Recruiting
Detroit,Michigan,48201,United States
Novartis Investigative Site
Recruiting
Atlantis,Florida,33462-6608,United States
Novartis Investigative Site
Recruiting
Phoenix,Arizona,85013,United States
Novartis Investigative Site
Recruiting
Indianapolis,Indiana,46256,United States
Novartis Investigative Site
Recruiting
Suwanee,Georgia,30024,United States
Novartis Investigative Site
Recruiting
Baton Rouge,Louisiana,70810,United States
Novartis Investigative Site
Recruiting
Greenville,South Carolina,29650,United States
Novartis Investigative Site
Recruiting
Detroit,Michigan,48202 2689,United States
Novartis Investigative Site
Recruiting
Madison,Wisconsin,53792,United States
Novartis Investigative Site
Recruiting
Aurora,Colorado,80045,United States
Novartis Investigative Site
Recruiting
Sarasota,Florida,34233,United States
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.