AzTrials
AzTrials

Relapsing Multiple SclerosisPhase 3ALITHIOSNCT03650114

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

A Phase 3 study testing Ofatumumab, Tetanus toxoid (TT) containing vaccine (Td, Tdap) and 13-valent pneumococcal conjugate vaccine (13-PCV) in people with Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals at 295 sites in 37 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Relapsing Multiple Sclerosis
What is being tested?
Ofatumumab, Tetanus toxoid (TT) containing vaccine (Td, Tdap) and 13-valent pneumococcal conjugate vaccine (13-PCV)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,882 participants
Where
295 sitesin 37 countries
Study dates
28 Dec 2018to 30 Sep 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
  • Written informed consent
  • Informed consent
  • Actively enrolled in the COMB157G2399 Study
  • 12 weeks of continuous treatment within the COMB157G2399 Study
  • prior vaccination history as per protocol-defined

Who cannot join

  • 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:
  • known hypersensitivity or history of systemic allergic, neurologic or other reactions to vaccines
Show all 10Show fewer
  • 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

Trial locations and contacts

295 sites in 37 countries.

295 sites in 37 countries

United States86 sites

  • Neurology and Neuroscience Assos

    Akron, Ohio, 44320

  • University of New Mexico

    Albuquerque, New Mexico, 87131-0001

  • Neuro Medical Clinic of Cenla LLC

    Alexandria, Louisiana, 71301

  • Asheville Neurology Specialists PA

    Asheville, North Carolina, 28806

  • Jem Research Institute

    Atlantis, Florida, 33462-6608

  • CU Anschutz Med Campus

    Aurora, Colorado, 80045

  • Mountain Neuro Research Center PC

    Basalt, Colorado, 81621

  • The Neuromedical Center

    Baton Rouge, Louisiana, 70810

  • Billings Clinic

    Billings, Montana, 59101

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233-0271

  • Alpine Clinical Research Center

    Boulder, Colorado, 80301

  • The Neurological Institute PA

    Charlotte, North Carolina, 28204

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Colorado Springs Neurological Associates

    Colorado Springs, Colorado, 80907

  • Ohio Health Research Institute

    Columbus, Ohio, 43214

  • Wesley Neurology Clinic

    Cordova, Tennessee, 38018

  • North Central Neurology Associates PC

    Cullman, Alabama, 35058

  • Neurology Offices of South Florida PLLC

    Delray Beach, Florida, 33445

  • Colorado Neurological Research PC

    Denver, Colorado, 80210

  • Wayne State University Multiple Sclerosis Clinic

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202-2689

  • Med Research Inc

    El Paso, Texas, 79935

  • University of Colorado Health Neurology

    Fort Collins, Colorado, 80528

  • Fullerton Neuro and Headache Ctr

    Fullerton, California, 92835

  • Advanced Neurology Specialists

    Great Falls, Montana, 59405

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Guilford Neurologic Associate Research

    Greensboro, North Carolina, 27405

  • Premier Neurology

    Greenville, South Carolina, 29605

  • Infinity Clinical Research LLC

    Hollywood, Florida, 33024

  • Homestead Assoc In Research Inc

    Homestead, Florida, 33033

  • Hawaii Pacific Neuroscience LLC

    Honolulu, Hawaii, 96817

  • Josephson Wallack Munshower Neurology PC

    Indianapolis, Indiana, 46256

  • Tri State Mountain Neurology

    Johnson, Tennessee, 37604

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • Evergreen Health Multiple Sclerosis Center

    Kirkland, Washington, 98034

  • University of Tennessee Medical Ctr

    Knoxville, Tennessee, 37920

  • Sibyl Wray MD Neurology PC

    Knoxville, Tennessee, 37922

  • Cleveland Clinic Foundation

    Las Vegas, Nevada, 89106

  • Ms Ctr Of Northeastern Ny

    Latham, New York, 12110

  • Neurology and Sleep Center

    Lubbock, Texas, 79410

  • University of Wisconsin Madison

    Madison, Wisconsin, 53792

  • Neurology Associates PA

    Maitland, Florida, 32751

  • UM Department Of Neurology

    Miami, Florida, 33136

  • Ascension St Francis Center

    Milwaukee, Wisconsin, 53215

  • St Luke s Medical Center Aurora

    Milwaukee, Wisconsin, 53215

  • Aqualane Clinical Research

    Naples, Florida, 34105

  • Christiana Care Health Services

    Newark, Delaware, 19713

  • Consultants in Neurology

    Northbrook, Illinois, 60062

  • Multiple Sclerosis Center of Excellence of OMRF

    Oklahoma City, Oklahoma, 73104

  • MS and Neuromuscular Center of Excellence

    Oldsmar, Florida, 34677

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida, 32174

  • College Park Family Care Center

    Overland Park, Kansas, 66210

  • Sharlin Health and Neurology

    Ozark, Missouri, 65721

  • Emerald Coast Neurology

    Pensacola, Florida, 32514

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107-5098

  • Barrow Neurological Clinics at St Josephs Hospital and MC

    Phoenix, Arizona, 85013

  • Vivo Infusion

    Plymouth, Minnesota, 55446

  • Neurostudies Inc

    Port Charlotte, Florida, 33952

  • Providence Neurological Services West

    Portland, Oregon, 97225

  • Velocity Clinical Research

    Raleigh, North Carolina, 27607

  • Central TX Neuro Consultants P A

    Round Rock, Texas, 78681

  • University of California Davis

    Sacramento, California, 95817

  • Rocky Mountain MS Clinic

    Salt Lake City, Utah, 84103

  • The University of Utah

    Salt Lake City, Utah, 84132-0001

  • Lonestar Neurology of San Antonio

    San Antonio, Texas, 78258

  • Negroski Neurology

    Sarasota, Florida, 34233

  • Roskamp Institute Inc

    Sarasota, Florida, 34243

  • Velocity Clinical Research

    Savannah, Georgia, 31406

  • Texas Institute for Neurological Disorders

    Sherman, Texas, 75092

  • BG Neurology

    Spartanburg, South Carolina, 29303

  • Upstate Clinical Trials LLC

    Spartanburg, South Carolina, 29303

  • WA Uni School Of Med

    St Louis, Missouri, 63110

  • Mercy Research

    St Louis, Missouri, 63141

  • Georgia Neurology and Sleep Medicine Assoc

    Suwanee, Georgia, 30024

  • MultiCare Research Institute for Research and Innovation

    Tacoma, Washington, 98405

  • AMO Corporation

    Tallahassee, Florida, 32312

  • Clinical Research of West Florida Inc

    Tampa, Florida, 33606

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • University Of South Florida

    Tampa, Florida, 33612

  • Sentara Neuroscience Institute

    Virginia Beach, Virginia, 23456

  • Dragonfly Research LLC

    Wellesley Hills, Massachusetts, 02481

  • Premiere Research Institute

    West Palm Beach, Florida, 33407

  • Columbus Neuroscience

    Westerville, Ohio, 43082

  • Abington Neurological Associates Ltd

    Willow Grove, Pennsylvania, 19090

  • PMG Research of Winston Salem

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany20 sites

  • Novartis Investigative Site

    Barsinghausen, 30890

  • Novartis Investigative Site

    Bayreuth, 95445

  • Novartis Investigative Site

    Bielefeld, 33647

  • Novartis Investigative Site

    Bochum, 44791

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50935

  • Novartis Investigative Site

    Dresden, Saxony, 01307

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Hamburg, 22179

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Leipzig, Saxony, 04103

  • Novartis Investigative Site

    Marburg, Hesse, 35043

  • Novartis Investigative Site

    Minden, 32429

  • Novartis Investigative Site

    München, 80377

  • Novartis Investigative Site

    Munich, Bavaria, 81377

  • Novartis Investigative Site

    Neuburg A.d. Donau, Bavaria, 86633

  • Novartis Investigative Site

    Potsdam, 14471

  • Novartis Investigative Site

    Siegen, 57076

  • Novartis Investigative Site

    Ulm, 89073

  • Novartis Investigative Site

    Unterhaching, Bavaria, 82008

Other trials in Germany

Spain19 sites

  • Novartis Investigative Site

    Barakaldo, Vizcaya, 48903

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Barcelona, 08035

  • Novartis Investigative Site

    Barcelona, 08036

  • Novartis Investigative Site

    Barcelona, 08041

  • Novartis Investigative Site

    Cadiz, Andalusia, 11009

  • Novartis Investigative Site

    Castilleja de la Cuesta, Sevilla, 41950

  • Novartis Investigative Site

    Donostia / San Sebastian, Gipuzkoa, 20014

  • Novartis Investigative Site

    El Palmar, Murcia, 30120

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Novartis Investigative Site

    Madrid, 28006

  • Novartis Investigative Site

    Madrid, 28034

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Majadahonda, Madrid, 28222

  • Novartis Investigative Site

    Málaga, 29010

  • Novartis Investigative Site

    Pozuelo de Alarcón, Madrid, 28223

  • Novartis Investigative Site

    Salt, Girona, 17190

  • Novartis Investigative Site

    Seville, 41009

  • Novartis Investigative Site

    Valencia, 46026

Other trials in Spain

Russia17 sites

  • Novartis Investigative Site

    Kazan', 420043

  • Novartis Investigative Site

    Kemerovo, 650066

  • Novartis Investigative Site

    Krasnoyarsk, 660049

  • Novartis Investigative Site

    Moscow, 119415

  • Novartis Investigative Site

    Moscow, 125367

  • Novartis Investigative Site

    Moscow, 127015

  • Novartis Investigative Site

    Nizhny Novgorod, 603137

  • Novartis Investigative Site

    Nizhny Novgorod, 603155

  • Novartis Investigative Site

    Novosibirsk, 630007

  • Novartis Investigative Site

    Novosibirsk, 630087

  • Novartis Investigative Site

    Saint Petersburg, 194044

  • Novartis Investigative Site

    Saint Petersburg, 197022

  • Novartis Investigative Site

    Saint Petersburg, 197376

  • Novartis Investigative Site

    Saransk, 430032

  • Novartis Investigative Site

    Sestroretsk, 197706

  • Novartis Investigative Site

    Tyumen, 625000

  • Novartis Investigative Site

    Yekaterinburg, 620109

Other trials in Russia

Poland12 sites

  • Novartis Investigative Site

    Bydgoszcz, Woj Kujawsko Pomorskie, 85-796

  • Novartis Investigative Site

    Gdansk, 80 803

  • Novartis Investigative Site

    Gdansk, 80-214

  • Novartis Investigative Site

    Glogow Wielkopolski, 36-060

  • Novartis Investigative Site

    Katowice, 40-571

  • Novartis Investigative Site

    Kielce, 25 726

  • Novartis Investigative Site

    Lodz, 90 324

  • Novartis Investigative Site

    Poznan, 60446

  • Novartis Investigative Site

    Rzeszów, 35-055

  • Novartis Investigative Site

    Warsaw, 02-957

  • Novartis Investigative Site

    Wroclaw, 51-685

  • Novartis Investigative Site

    Zabrze, 41-800

Other trials in Poland

Czechia11 sites

  • Novartis Investigative Site

    Brno, 602 00

  • Novartis Investigative Site

    Havířov, 736 01

  • Novartis Investigative Site

    Hradec Králové, 500 05

  • Novartis Investigative Site

    Jihlava, 586 01

  • Novartis Investigative Site

    Olomouc, 779 00

  • Novartis Investigative Site

    Pardubice, 532 03

  • Novartis Investigative Site

    Prague, 100 34

  • Novartis Investigative Site

    Prague, 128 08

  • Novartis Investigative Site

    Prague, 140 59

  • Novartis Investigative Site

    Prague, 150 06

  • Novartis Investigative Site

    Teplice, 415 29

Other trials in Czechia

Japan11 sites

  • Novartis Investigative Site

    Chiba, 2608677

  • Novartis Investigative Site

    Kawagoe, Saitama, 3508550

  • Novartis Investigative Site

    Kodaira, Tokyo, 187-8551

  • Novartis Investigative Site

    Niigata, 9518520

  • Novartis Investigative Site

    Osaka, 5560016

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0630005

  • Novartis Investigative Site

    Sendai, Miyagi, 9808574

  • Novartis Investigative Site

    Sendai, Miyagi, 9838512

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 1608582

  • Novartis Investigative Site

    Shiwa-Gun, Iwate, 0283695

  • Novartis Investigative Site

    Tōon, Ehime, 7910295

Other trials in Japan

Turkey (Türkiye)11 sites

  • Novartis Investigative Site

    Istanbul, Bakirkoy, 34147

  • Novartis Investigative Site

    Istanbul, Fatih, 34098

  • Novartis Investigative Site

    Istanbul, Sancaktepe, 34785

  • Novartis Investigative Site

    Istanbul, Sultangazi, 34295

  • Novartis Investigative Site

    Izmir, Balcova, 35340

  • Novartis Investigative Site

    Izmir, Karsiyaka, 35575

  • Novartis Investigative Site

    Izmir, 35100

  • Novartis Investigative Site

    Kocaeli, 41380

  • Novartis Investigative Site

    Mersin, Yenisehir, 33110

  • Novartis Investigative Site

    Samsun, Atakum, 55200

  • Novartis Investigative Site

    Trabzon, Ortahisar, 61080

Other trials in Turkey (Türkiye)

India9 sites

  • Novartis Investigative Site

    Chandigarh, Punjab, 160012

  • Novartis Investigative Site

    Howrah, West Bengal, 711103

  • Novartis Investigative Site

    Hyderabad, Telangana, 500082

  • Novartis Investigative Site

    Kochi, Kerala, 682 026

  • Novartis Investigative Site

    Mangalore, Karnataka, 575018

  • Novartis Investigative Site

    Mumbai, Maharashtra, 400008

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110017

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110060

  • Novartis Investigative Site

    Pune, Maharashtra, 411004

Other trials in India

Portugal8 sites

  • Novartis Investigative Site

    Braga, 4710243

  • Novartis Investigative Site

    Coimbra, 3004-561

  • Novartis Investigative Site

    Lisbon, 1169-050

  • Novartis Investigative Site

    Lisbon, 1500 650

  • Novartis Investigative Site

    Loures, 2674-514

  • Novartis Investigative Site

    Matosinhos Municipality, 4454-513

  • Novartis Investigative Site

    Porto, 4099-001

  • Novartis Investigative Site

    Santa Maria da Feira, 4520-211

Other trials in Portugal

Canada7 sites

  • Novartis Investigative Site

    Gatineau, Quebec, J9J 0A5

  • Novartis Investigative Site

    Greenfield Park, Quebec, J4V 2J2

  • Novartis Investigative Site

    London, Ontario, N6A 5W9

  • Novartis Investigative Site

    Montreal, Quebec, H3A 2B4

  • Novartis Investigative Site

    Ottawa, Ontario, K1H 8L6

  • Novartis Investigative Site

    Québec, Quebec, G1J 1Z4

  • Novartis Investigative Site

    Toronto, Ontario, M4N 3M5

Other trials in Canada

France7 sites

  • Novartis Investigative Site

    Lille, 59037

  • Novartis Investigative Site

    Montpellier, 34090

  • Novartis Investigative Site

    Nantes, 44093

  • Novartis Investigative Site

    Nice, 06001

  • Novartis Investigative Site

    Nîmes, 30029

  • Novartis Investigative Site

    Paris, 75013

  • Novartis Investigative Site

    Strasbourg, 67000

Other trials in France

Hungary7 sites

  • Novartis Investigative Site

    Budapest, HUN, 1135

  • Novartis Investigative Site

    Budapest, 1044

  • Novartis Investigative Site

    Budapest, 1106

  • Novartis Investigative Site

    Budapest, 1204

  • Novartis Investigative Site

    Kistarcsa, 2143

  • Novartis Investigative Site

    Pécs, Baranya, 7623

  • Novartis Investigative Site

    Szeged, 6725

Other trials in Hungary

Slovakia7 sites

  • Novartis Investigative Site

    Banská Bystrica, 975 17

  • Novartis Investigative Site

    Bratislava, 813 69

  • Novartis Investigative Site

    Bratislava, 826 06

  • Novartis Investigative Site

    Bratislava, 833 05

  • Novartis Investigative Site

    Martin, 036 59

  • Novartis Investigative Site

    Nitra, 950 01

  • Novartis Investigative Site

    Trnava, 917 02

Other trials in Slovakia

United Kingdom6 sites

  • Novartis Investigative Site

    Glasgow, Scotland, G51 4TF

  • Novartis Investigative Site

    London, E1 1BB

  • Novartis Investigative Site

    London, SW17 0QT

  • Novartis Investigative Site

    Luton, Beds, LU4 0DZ

  • Novartis Investigative Site

    Oxford, OX3 9DU

  • Novartis Investigative Site

    Sheffield, South Yorkshire, S10 2JF

Other trials in United Kingdom

Argentina5 sites

  • Novartis Investigative Site

    Buenos Aires, C1424BYD

  • Novartis Investigative Site

    Córdoba, X5004CDT

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000BZL

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DSW

  • Novartis Investigative Site

    San Miguel de Tucumán, 4000

Other trials in Argentina

Belgium5 sites

  • Novartis Investigative Site

    Brasschaat, 2930

  • Novartis Investigative Site

    Bruges, 8000

  • Novartis Investigative Site

    Brussels, 1200

  • Novartis Investigative Site

    Edegem, 2650

  • Novartis Investigative Site

    Ghent, 9000

Other trials in Belgium

Bulgaria4 sites

  • Novartis Investigative Site

    Pleven, 5800

  • Novartis Investigative Site

    Sofia, 1113

  • Novartis Investigative Site

    Sofia, 1309

  • Novartis Investigative Site

    Sofia, 1431

Other trials in Bulgaria

Israel4 sites

  • Novartis Investigative Site

    Ashkelon, 7830604

  • Novartis Investigative Site

    Haifa, 3109601

  • Novartis Investigative Site

    Sefad, 1311300

  • Novartis Investigative Site

    Tel Aviv, 6423906

Other trials in Israel

Australia3 sites

  • Novartis Investigative Site

    Liverpool, 2170

  • Novartis Investigative Site

    New Lambton Heights, New South Wales, 2305

  • Novartis Investigative Site

    St Leonards, 2065

Other trials in Australia

Croatia3 sites

  • Novartis Investigative Site

    Osijek, 31000

  • Novartis Investigative Site

    Rijeka, 51000

  • Novartis Investigative Site

    Zagreb, 10000

Other trials in Croatia

Latvia3 sites

  • Novartis Investigative Site

    Riga, LV, LV-1005

  • Novartis Investigative Site

    Riga, LV 1002

  • Novartis Investigative Site

    Riga, LV-1038

Other trials in Latvia

Mexico3 sites

  • Novartis Investigative Site

    Chihuahua City, 31238

  • Novartis Investigative Site

    Mexico City, Mexico City, 03100

  • Novartis Investigative Site

    Mexico City, Mexico City, 06700

Other trials in Mexico

Netherlands3 sites

  • Novartis Investigative Site

    Amsterdam, North Holland, 1081 HV

  • Novartis Investigative Site

    Rotterdam, South Holland, 3015 GD

  • Novartis Investigative Site

    Sittard-Geleen, Limburg, 6162 BG

Other trials in Netherlands

Peru3 sites

  • Novartis Investigative Site

    Lima, 13

  • Novartis Investigative Site

    Lima Cercado, Lima region, 01

  • Novartis Investigative Site

    San Isidro, Lima region, 27

Other trials in Peru

Austria2 sites

  • Novartis Investigative Site

    Vienna, 1010

  • Novartis Investigative Site

    Vienna, 1090

Other trials in Austria

Denmark2 sites

  • Novartis Investigative Site

    Glostrup Municipality, 2600

  • Novartis Investigative Site

    Odense C, 5000

Other trials in Denmark

Estonia2 sites

  • Novartis Investigative Site

    Tallinn, 10617

  • Novartis Investigative Site

    Tartu, 50406

Other trials in Estonia

Finland2 sites

  • Novartis Investigative Site

    Tampere, 33100

  • Novartis Investigative Site

    Turku, 20520

Other trials in Finland

Greece2 sites

  • Novartis Investigative Site

    Athens, 115 25

  • Novartis Investigative Site

    Thessaloniki, 54636

Other trials in Greece

Lithuania2 sites

  • Novartis Investigative Site

    Kaunas, LTU, LT 50161

  • Novartis Investigative Site

    Vilnius, LT-08406

Other trials in Lithuania

South Africa2 sites

  • Novartis Investigative Site

    Pretoria, 0041

  • Novartis Investigative Site

    Rosebank, 2196

Other trials in South Africa

Sweden2 sites

  • Novartis Investigative Site

    Gothenburg, 413 45

  • Novartis Investigative Site

    Stockholm, 102 35

Other trials in Sweden

Switzerland2 sites

  • Novartis Investigative Site

    Basel, 4031

  • Novartis Investigative Site

    Lugano, 6900

Other trials in Switzerland

Norway1 site

  • Novartis Investigative Site

    Drammen, 3012

Other trials in Norway

Taiwan1 site

  • Novartis Investigative Site

    Tainan, 704302

Other trials in Taiwan

Thailand1 site

  • Novartis Investigative Site

    Khon Kaen, THA, 40002

Other trials in Thailand

About this study

Official title: An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis

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).

Read more

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.

Being tested
Ofatumumab, Tetanus toxoid (TT) containing vaccine (Td, Tdap), 13-valent pneumococcal conjugate vaccine (13-PCV), 23-valent pneumococcal polysaccharide vaccine (23-PPV), Seasonal Quadrivalent influenza vaccine
Keywords
ofatumumab, relapsing multiple sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OfatumumabBiological

    subcutaneous injection of 20 mg ofatumumab every 4 weeks

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

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

  • 13-valent pneumococcal conjugate vaccine (13-PCV)Biological

    0.5mL Vial/Syringe

  • 23-valent pneumococcal polysaccharide vaccine (23-PPV)Biological

    0.5mL Vial/Syringe

  • Seasonal Quadrivalent influenza vaccineBiological

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

  • Keyhole limpet hemocyanin (KLH) neo-antigenBiological

    1mg Vial

Study groups in NCT03650114
Study groupRoleWhat they receive
OfatumumabExperimentalSubcutaneous injection
Receives: Biological: Ofatumumab; Biological: Tetanus toxoid (TT) containing vaccine (Td, Tdap); Biological: 13-valent pneumococcal conjugate vaccine (13-PCV); Biological: 23-valent pneumococcal polysaccharide vaccine (23-PPV); Biological: Seasonal Quadrivalent influenza vaccine; Biological: Keyhole limpet hemocyanin (KLH) neo-antigen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients that experience an adverse event or abnormal laboratory, vital and/or ECG results and positive suicidiality outcomes

    Measured: Up to 8 years

Secondary outcomes (9)

  1. Number of relapse rates per year

    Annual Relapse Rate (ARR) time calculated as number of confirmed relapses divided by time in study per year and will also be presented for the entire duration

    Measured: Data from the core studies through the first 5 years in this study.

  2. Patients with confirmed 3 and 6 month disability worsening

    A confirmed disability worsening is an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at last 3, or 6 months EDSS consists of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral functions (Fatigue contributes).

    Measured: During the first 5 years of treatment in the study.

  3. Patients with confirmed 6, 12, and 24 month disability improvement and improvement during the first 5 years of the study.

    Confirmed disability improvement is a decrease from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 6, 12 or 24 months EDSS consists of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral functions (Fatigue contributes).

    Measured: During the first 5 years of treatment in the study.

  4. Patients with changes in Expanded Disability Status Scale (EDSS) scores

    Score changes in Expanded Disability Status Scale (EDSS) over time EDSS consists of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral functions (Fatigue contributes).

    Measured: Data from the core studies through the first 5 years in this study, (depending on if first dose was in the core or in this extension study or comparator randomization)

  5. Changes in and time to 6 month confirmed worsening of Symbol Digit Modalities Test Scores

    Score changes and confirmed 4-point worsening sustained for 6 months in Symbol Digit Modalities Test (SDMT) scores The Symbol Digit Modalities Test is a neuropsychological, timed test for sustained attention and concentration. 3 versions will be used, alternating at each visit where done. The number of correct responses will be counted for the score.

    Measured: During the first 5 years of the study.

  6. Changes in the Magnetic Resonance Image (MRI) related to brain volume loss

    Percent change from baseline in brain volume loss (BVL)

    Measured: Data from the core studies through the first 5 years in this study.

  7. Changes in the Magnetic Resonance Image (MRI) related to T2 lesions

    Number of new or enlarging T2 lesions

    Measured: Data from the core studies through the first 5 years in this study.

  8. Changes in the Magnetic Resonance Image (MRI) related to Gd-enhancing lesions

    Total number of Gd-enhancing lesions on all MRI scans adjusted for different time of scan versus follow up time in study

    Measured: Data from the core studies through the first 5 years in this study.

  9. Changes in neurofilament light change serum concentration

    Extent of neurofilament light change concentration in blood NfL is a component of the neuronal cytoskeleton and is released into the cerebrospinal fluid and into subsequently blood following neuro-axonal damage

    Measured: Data from the core studies through the first 5 years in this study.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2018
  2. Study start28 Dec 2018
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,882 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03650114
Sponsor's protocol ID
COMB157G2399
Other IDs
2023-507906-15, 2023
Acronym
ALITHIOS
Status last verified
May 2026
First submitted
17 Aug 2018
Last updated
27 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Hauser SL, Cohen JA, de Seze J, Meuth SG, Giacomini PS, Nakahara J, Oreja-Guevara C, Robertson D, Wray S, Bhatt A, Hu X, Xi J, Piccolo R, Jehl V, Sullivan R, Boer I, Wiendl H, Kappos L. Five-Year Safety and Efficacy Outcomes with Ofatumumab in Patients with Relapsing Multiple Sclerosis. Neurol Ther. 2025 Oct;14(5):1975-1992. doi: 10.1007/s40120-025-00784-0. Epub 2025 Jul 13.

    PubMed 40652442

  • Hauser SL, Zielman R, Das Gupta A, Xi J, Stoneman D, Karlsson G, Robertson D, Cohen JA, Kappos L. Efficacy and safety of four-year ofatumumab treatment in relapsing multiple sclerosis: The ALITHIOS open-label extension. Mult Scler. 2023 Oct;29(11-12):1452-1464. doi: 10.1177/13524585231195346. Epub 2023 Sep 11.

    PubMed 37691530

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ofatumumab, Tetanus toxoid (TT) containing vaccine (Td, Tdap) and 13-valent pneumococcal conjugate vaccine (13-PCV) in people with Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals at 295 sites in 37 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 295 sites in United States, Germany, Spain, Russia, Poland and 32 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients that experience an adverse event or abnormal laboratory, vital and/or ECG results and positive suicidiality outcomes (time frame: Up to 8 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03650114, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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