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New hope for MS patients: ofatumumab cuts relapses in switchers

NCT ID NCT04353492

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well ofatumumab works in 562 people with relapsing multiple sclerosis who switched from other drugs (fumarates or fingolimod) because their disease was still active. The main goal was to see how many relapses they had per year. Researchers also tracked side effects. The study is complete and provides real-world evidence on this treatment option.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

562 people

The number who actually took part.

Started

Jul 2020

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of MS according to the 2017 Revised McDonald criteria * Relapsing MS: relapsing forms of MS (RMS) including RMS and secondary progressive MS (SPMS) * Disability status at screening defined by Expanded Disability Status Scale (EDSS) score of 0 to 4 (inclusive) * MS treatment history with a maximum of 3 Disease Modifying Therapies (DMTs), where all fumarates are considered as one DMT * Subject transitioning from either any fumarate-based RMS approved therapies, such as dimethyl fumarate (DMF) or diroximel fumarate (DRF), or fingolimod which was administered for a period of at least 6 months, as their last DMT before first study drug administration * Breakthrough disease activity while the participant was adequately using fumarates or fingolimod prior to transitioning for a minimum of 6 months as evidenced by one or more clinically reported relapses or one or more signs of Magnetic Resonance Imaging (MRI) activity (e.g. Gd+ enhancement, new or enlarging T2 lesions) * Neurologically stable within one month prior to first study drug administration Exclusion Criteria: * Subjects with primary progressive MS or SPMS without disease activity * Subjects meeting criteria for neuromyelitis optica * Disease duration of more than 10 years since diagnosis * Pregnant or nursing (lactating) women * Women of child-bearing potential unless they are using highly effective forms of contraception during dosing and for at least 6 months after stopping study medication * Subjects with active chronic disease of the immune system other than MS or with immunodeficiency syndrome * Subjects with active systemic bacterial, fungal or viral infections (such as hepatitis, HIV, COVID-19), or known to have Acquired Immunodeficiency Syndrome (AIDS) * Subjects with neurological symptoms consistent with Progressive Multifocal Leukoencephalopathy (PML) or with confirmed PML * Subjects at risk of developing or having reactivation of syphilis or tuberculosis (e.g. subjects with known exposure to, or history of syphilis, or active or latent tuberculosis, even if previously treated), as confirmed by medical history or per local practice * Subjects with active hepatitis B and C disease, assessed locally * Have received any live or live-attenuated vaccines within 4 weeks prior to first study drug administration * Have been treated with medications as specified or within timeframes specified (e.g. corticosteroids, ofatumumab, rituximab, ocrelizumab, alemtuzumab, natalizumab, daclizumab, cyclophosphamide, teriflunomide etc.) * Subjects suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the investigator

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Conditions

The condition(s) this trial relates to.

multiple sclerosis relapsing-remitting multiple sclerosis secondary progressive multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsing multiple sclerosis

Contacts and locations

Locations

  • Ascension St Francis Center

    Milwaukee, Wisconsin, 53215, United States

  • Atlanta Neuroscience Institute

    Atlanta, Georgia, 30327, United States

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • CU Anschutz Med Campus

    Aurora, Colorado, 80045, United States

  • Christiana Care Health Services

    Newark, Delaware, 19713, United States

  • Cleveland Clinic Foundation

    Las Vegas, Nevada, 89106, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Columbus Neuroscience

    Westerville, Ohio, 43082, United States

  • Five Towns Neuroscience Research

    Woodmere, New York, 11598, United States

  • Fullerton Neuro and Headache Ctr

    Fullerton, California, 92835, United States

  • Georgia Neurology and Sleep Medicine Assoc

    Suwanee, Georgia, 30024, United States

  • Homestead Assoc In Research Inc

    Homestead, Florida, 33033, United States

  • INOVA Medical Group

    Fairfax, Virginia, 22030, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Memorial Healthcare System

    Hollywood, Florida, 33021, United States

  • Multiple Sclerosis Center of Excellence of OMRF

    Oklahoma City, Oklahoma, 73104, United States

  • Negroski Neurology

    Sarasota, Florida, 34233, United States

  • Neurology Associates PA

    Maitland, Florida, 32751, United States

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000BZL, Argentina

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DSW, Argentina

  • Novartis Investigative Site

    Buenos Aires, C1424BYD, Argentina

  • Novartis Investigative Site

    San Miguel de Tucumán, 4000, Argentina

  • Novartis Investigative Site

    New Lambton Heights, New South Wales, 2305, Australia

  • Novartis Investigative Site

    Woolloongabba, Queensland, 4102, Australia

  • Novartis Investigative Site

    Parkville, Victoria, 3050, Australia

  • Novartis Investigative Site

    Vienna, State of Vienna, 1010, Austria

  • Novartis Investigative Site

    Linz, Upper Austria, A 4020, Austria

  • Novartis Investigative Site

    Linz, 4020, Austria

  • Novartis Investigative Site

    Vienna, 1090, Austria

  • Novartis Investigative Site

    Bruges, 8000, Belgium

  • Novartis Investigative Site

    Brussels, 1200, Belgium

  • Novartis Investigative Site

    Edegem, 2650, Belgium

  • Novartis Investigative Site

    Pleven, Bulgaria, 5800, Bulgaria

  • Novartis Investigative Site

    Sofia, Bulgaria, 1431, Bulgaria

  • Novartis Investigative Site

    Pleven, 5800, Bulgaria

  • Novartis Investigative Site

    Sofia, 1113, Bulgaria

  • Novartis Investigative Site

    Sofia, 1431, Bulgaria

  • Novartis Investigative Site

    Toronto, Ontario, M4N 3M5, Canada

  • Novartis Investigative Site

    Brno, 602 00, Czechia

  • Novartis Investigative Site

    Havířov, 736 01, Czechia

  • Novartis Investigative Site

    Hradec Králové, 500 05, Czechia

  • Novartis Investigative Site

    Prague, 128 08, Czechia

  • Novartis Investigative Site

    Teplice, 415 29, Czechia

  • Novartis Investigative Site

    Tallinn, 11315, Estonia

  • Novartis Investigative Site

    Tartu, 50406, Estonia

  • Novartis Investigative Site

    Munich, Bavaria, 81377, Germany

  • Novartis Investigative Site

    Cottbus, Brandenburg, 03048, Germany

  • Novartis Investigative Site

    Osnabrück, Lower Saxony, 49076, Germany

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50935, Germany

  • Novartis Investigative Site

    Bielefeld, 33647, Germany

  • Novartis Investigative Site

    Heidelberg, 69120, Germany

  • Novartis Investigative Site

    Leipzig, 04275, Germany

  • Novartis Investigative Site

    Potsdam, 14471, Germany

  • Novartis Investigative Site

    Siegen, 57076, Germany

  • Novartis Investigative Site

    Ulm, 89073, Germany

  • Novartis Investigative Site

    Ulm, 89081, Germany

  • Novartis Investigative Site

    Westerstede Olden, 26655, Germany

  • Novartis Investigative Site

    Larissa, 411 10, Greece

  • Novartis Investigative Site

    Thessaloniki, 53246, Greece

  • Novartis Investigative Site

    Thessaloniki, GR 54636, Greece

  • Novartis Investigative Site

    Budapest, HUN, 1135, Hungary

  • Novartis Investigative Site

    Budapest, 1138, Hungary

  • Novartis Investigative Site

    Budapest, 1204, Hungary

  • Novartis Investigative Site

    Pécs, 7623, Hungary

  • Novartis Investigative Site

    Florence, FI, 50134, Italy

  • Novartis Investigative Site

    Pavia, PV, 27100, Italy

  • Novartis Investigative Site

    Roma, RM, 00152, Italy

  • Novartis Investigative Site

    Verona, VR, 37134, Italy

  • Novartis Investigative Site

    Riga, LV, LV-1005, Latvia

  • Novartis Investigative Site

    Riga, LV 1002, Latvia

  • Novartis Investigative Site

    Beirut, 113-0236, Lebanon

  • Novartis Investigative Site

    Beirut, 166830, Lebanon

  • Novartis Investigative Site

    Beirut, 8610, Lebanon

  • Novartis Investigative Site

    Mexico City, Mexico City, 03100, Mexico

  • Novartis Investigative Site

    Mexico City, Mexico City, 06700, Mexico

  • Novartis Investigative Site

    Morelia, Michoacán, 58260, Mexico

  • Novartis Investigative Site

    Oslo, NO-0407, Norway

  • Novartis Investigative Site

    Bydgoszcz, Woj Kujawsko Pomorskie, 85-796, Poland

  • Novartis Investigative Site

    Katowice, 40-571, Poland

  • Novartis Investigative Site

    Kielce, 25 726, Poland

  • Novartis Investigative Site

    Lodz, 90-153, Poland

  • Novartis Investigative Site

    Wroclaw, 51-685, Poland

  • Novartis Investigative Site

    Braga, 4710243, Portugal

  • Novartis Investigative Site

    Lisbon, 1349-019, Portugal

  • Novartis Investigative Site

    Loures, 2674-514, Portugal

  • Novartis Investigative Site

    Porto, 4099-001, Portugal

  • Novartis Investigative Site

    Moscow, 115516, Russia

  • Novartis Investigative Site

    Moscow, 127015, Russia

  • Novartis Investigative Site

    Saint Petersburg, 190000, Russia

  • Novartis Investigative Site

    Riyadh, SAU, 11525, Saudi Arabia

  • Novartis Investigative Site

    Jeddah, 21499, Saudi Arabia

  • Novartis Investigative Site

    Banská Bystrica, Slovakia, 975 17, Slovakia

  • Novartis Investigative Site

    Bratislava, Slovakia, 813 69, Slovakia

  • Novartis Investigative Site

    Bratislava, Slovakia, 826 06, Slovakia

  • Novartis Investigative Site

    Bratislava, Slovakia, 833 05, Slovakia

  • Novartis Investigative Site

    Košice, Slovakia, 041 90, Slovakia

  • Novartis Investigative Site

    Nitra, Slovakia, 950 01, Slovakia

  • Novartis Investigative Site

    Trnava, Slovakia, 917 02, Slovakia

  • Novartis Investigative Site

    Maribor, Slovenia, 2000, Slovenia

  • Novartis Investigative Site

    Ljubljana, 1000, Slovenia

  • Novartis Investigative Site

    Seville, Andalusia, 41009, Spain

  • Novartis Investigative Site

    El Palmar, Murcia, 30120, Spain

  • Novartis Investigative Site

    Santa Cruz, Santa Cruz de Tenerife, 38009, Spain

  • Novartis Investigative Site

    Barakaldo, Vizcaya, 48903, Spain

  • Novartis Investigative Site

    Barcelona, 08041, Spain

  • Novartis Investigative Site

    Madrid, 28040, Spain

  • Novartis Investigative Site

    Valencia, 46010, Spain

  • Novartis Investigative Site

    Valencia, 46026, Spain

  • Novartis Investigative Site

    Basel, 4031, Switzerland

  • Novartis Investigative Site

    Samsun, Atakum, 55200, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, Fatih, 34098, Turkey (Türkiye)

  • Novartis Investigative Site

    Trabzon, Ortahisar, 61080, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, Sancaktepe, 34785, Turkey (Türkiye)

  • Novartis Investigative Site

    Izmir, 35100, Turkey (Türkiye)

  • Novartis Investigative Site

    Cardiff, CF14 4XW, United Kingdom

  • Novartis Investigative Site

    Swansea, SA2 8QA, United Kingdom

  • Premiere Research Institute

    West Palm Beach, Florida, 33407, United States

  • Saturn Research Solutions LLC

    Plano, Texas, 75024, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107-5098, United States

  • UM Department Of Neurology

    Miami, Florida, 33136, United States

  • University Of South Florida

    Tampa, Florida, 33612, United States

  • University of New Mexico

    Albuquerque, New Mexico, 87131-0001, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.