Last Update: Feb 05, 2024
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:
Novartis Reference Number:COMB157G2399
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).

Relapsing Multiple Sclerosis
Phase 3
Recruiting
2060
Dec 28, 2018
Sep 07, 2028
All
18 Years - 100 Years (Adult, Older Adult)

Interventions

Biological

13-valent pneumococcal conjugate vaccine (13-PCV)

0.5mL Vial/Syringe
Biological

23-valent pneumococcal polysaccharide vaccine (23-PPV)

0.5mL Vial/Syringe
Biological

Keyhole limpet hemocyanin (KLH) neo-antigen

1mg Vial
Biological

Ofatumumab

subcutaneous injection of 20 mg ofatumumab every 4 weeks
Biological

Seasonal Quadrivalent influenza vaccine

Seasonal 2020-2021 0.5mL Vial/Syringe (trivalent may be used where quadrivalent is not available)
Biological

Tetanus toxoid (TT) containing vaccine (Td, Tdap)

0.5mL Vial/Syringe Containing 5 limit of flocculation (LF) tetanus toxoid

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

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Sofia,1113,Bulgaria

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Sofia,1413,Bulgaria

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Pleven,5800,Bulgaria

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Havirov,Czech Republic,736 01,Czech Republic

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Brno,Czech Republic,656 91,Czech Republic

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Hradec Kralove,CZE,500 05,Czech Republic

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Ostrava Poruba,708 52,Czech Republic

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Teplice,Czech Republic,415 01,Czech Republic

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Lille Cedex,59037,France

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Paris 13,75651,France

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Nice,Cedex1,06001,France

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Strasbourg,67000,France

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Nantes Cedex 1,44093,France

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Thessaloniki,GR 54636,Greece

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Pecs,7623,Hungary

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Budapest,HUN,1135,Hungary

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Budapest,HUN,1138,Hungary

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Budapest,HUN,1204,Hungary

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Warszawa,02 957,Poland

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Rzeszow,35 055,Poland

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Bydgoszcz,Woj Kujawsko-pomorskie,85-796,Poland

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Kielce,25 726,Poland

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Katowice,40 571,Poland

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Coimbra,3000 075,Portugal

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Santa Maria da Feira,4520 211,Portugal

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Braga,4710243,Portugal

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Novosibirsk,630007,Russian Federation

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Kemerovo,650066,Russian Federation

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Novosibirsk,630087,Russian Federation

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Ekaterinburg,620109,Russian Federation

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St Petersburg,190000,Russian Federation

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St. Petersburg,197376,Russian Federation

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Tyumen,625000,Russian Federation

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Sestroretsk,197706,Russian Federation

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Saint Petersburg,194044,Russian Federation

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Moscow,125367,Russian Federation

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Nizhny Novgorod,603137,Russian Federation

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Saint Petersburg,197022,Russian Federation

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Moscow,127015,Russian Federation

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Krasnoyarsk,660049,Russian Federation

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Nizhny Novgorod,603155,Russian Federation

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Kazan,420043,Russian Federation

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Saransk,430032,Russian Federation

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Bratislava,813 69,Slovakia

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Martin,036 59,Slovakia

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Bratislava,82606,Slovakia

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Banska Bystrica,975 17,Slovakia

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Bratislava,83305,Slovakia

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Trnava,917 75,Slovakia

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Nitra,94901,Slovakia

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Pretoria,0041,South Africa

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Rosebank,2196,South Africa

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Madrid,28006,Spain

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Cadiz,Andalucia,11009,Spain

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Madrid,28034,Spain

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Castilleja De La Cuesta,Sevilla,41950,Spain

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Madrid,28040,Spain

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Pozuelo de Alarcon,Madrid,28223,Spain

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El Palmar,Murcia,30120,Spain

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Baracaldo,Vizcaya,48903,Spain

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San Sebastian,Pais Vasco,20080,Spain

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Madrid,28222,Spain

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Barcelona,Cataluna,08026,Spain

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Hospitalet de Llobregat,Barcelona,08907,Spain

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Valencia,46026,Spain

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Sevilla,Andalucia,41009,Spain

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Barcelona,Catalunya,08035,Spain

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Malaga,Andalucia,29010,Spain

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Barcelona,Catalunya,08036,Spain

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Salt,Cataluna,17190,Spain

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Samsun,55139,Turkey

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Istanbul,TUR,34098,Turkey

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Trabzon,61080,Turkey

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Izmir,35040,Turkey

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Izmir,35575,Turkey

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Sancaktepe,Istanbul,34785,Turkey

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London,E1 1BB,United Kingdom

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Headington,Oxfordshire,OX3 9DU,United Kingdom

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London,SW17 0QT,United Kingdom

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Luton,Beds,LU4 0DZ,United Kingdom

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Glasgow,G51 4TF,United Kingdom

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Las Vegas,Nevada,89106,United States

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Indianapolis,Indiana,46256,United States

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Overland Park,Kansas,66210,United States

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Baton Rouge,Louisiana,70810,United States

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Greenville,South Carolina,29650,United States

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Sarasota,Florida,34233,United States

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Port Charlotte,Florida,33952,United States

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Aurora,Colorado,80045,United States

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Detroit,Michigan,48202 2689,United States

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Tacoma,Washington,98405,United States

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Naples,Florida,34102,United States

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West Palm Beach,Florida,33407,United States

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Miami,Florida,33032,United States

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Sacramento,California,95817,United States

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Colorado Springs,Colorado,80907,United States

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Billings,Montana,59101,United States

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Sarasota,Florida,34243,United States

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Portland,Oregon,97225,United States

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Tallahassee,Florida,32312,United States

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Newark,Delaware,19713,United States

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San Antonio,Texas,78258,United States

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Willow Grove,Pennsylvania,19090,United States

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Columbus,Ohio,43214,United States

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Miami,Florida,33136,United States

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Saint Louis,Missouri,63110,United States

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Oklahoma City,Oklahoma,73104,United States

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Birmingham,Alabama,35233-0271,United States

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Kirkland,Washington,98034,United States

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Savannah,Georgia,31406,United States

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Tampa,Florida,33603,United States

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Pensacola,Florida,32514,United States

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Cordova,Tennessee,38018,United States

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Milwaukee,Wisconsin,53215,United States

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Albuquerque,New Mexico,87131-0001,United States

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Saint Louis,Missouri,63141,United States

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Honolulu,Hawaii,96817,United States

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Oldsmar,Florida,34677,United States

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Boulder,Colorado,80301,United States

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Knoxville,Tennessee,37920,United States

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Charlotte,North Carolina,28204,United States

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El Paso,Texas,79935,United States

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Tampa,Florida,33609,United States

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Kansas City,Kansas,66160-7330,United States

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Philadelphia,Pennsylvania,19107-5098,United States

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Lubbock,Texas,79410,United States

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Cullman,Alabama,35058,United States

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Alexandria,Louisiana,71301,United States

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Ormond Beach,Florida,32174,United States

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Bradenton,Florida,34205,United States

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Knoxville,Tennessee,37922,United States

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Raleigh,North Carolina,27607,United States

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Chicago,Illinois,60612,United States

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Maitland,Florida,32751,United States

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Fullerton,California,92835,United States

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Tampa,Florida,33612,United States

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Phoenix,Arizona,85013,United States

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Delray Beach,Florida,33445,United States

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Sunrise,Florida,33351,United States

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Asheville,North Carolina,28806,United States

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Virginia Beach,Virginia,23456,United States

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Cleveland,Ohio,44195,United States

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Sherman,Texas,75092,United States

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Madison,Wisconsin,53792,United States

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Atlantis,Florida,33462-6608,United States

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Detroit,Michigan,48201,United States

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Suwanee,Georgia,30024,United States

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