An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab
Launched by NOVARTIS PHARMACEUTICALS · Apr 16, 2020
Trial Information
Current as of May 15, 2025
Completed
Keywords
ClinConnect Summary
This is a single arm, prospective, multicentre and open-label, 96-week study to evaluate the treatment effectiveness of ofatumumab (OMB) in subjects with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies, such as dimethyl fumarate (DMF), diroximel fumarate (DRF), and monomethyl fumarate (MMF), or fingolimod due to breakthrough disease activity.
Gender
ALL
Eligibility criteria
- 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
About Novartis Pharmaceuticals
Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Houston, Texas, United States
West Palm Beach, Florida, United States
Tampa, Florida, United States
Cleveland, Ohio, United States
Baltimore, Maryland, United States
Albuquerque, New Mexico, United States
Maitland, Florida, United States
Albuquerque, New Mexico, United States
Tampa, Florida, United States
Bruxelles, , Belgium
Madrid, , Spain
Kosice, , Slovakia
Fullerton, California, United States
Aurora, Colorado, United States
Hollywood, Florida, United States
Newark, Delaware, United States
Boston, Massachusetts, United States
Cleveland, Ohio, United States
Pavia, Pv, Italy
Lodz, , Poland
Basel, , Switzerland
Toronto, Ontario, Canada
Boston, Massachusetts, United States
Baltimore, Maryland, United States
Houston, Texas, United States
Milwaukee, Wisconsin, United States
Woolloongabba, Queensland, Australia
Regensburg, Bavaria, Germany
Heidelberg, , Germany
Baracaldo, Vizcaya, Spain
Swansea, , United Kingdom
Edegem, , Belgium
Miami, Florida, United States
Parkville, Victoria, Australia
Nedlands, Western Australia, Australia
Vienna, , Austria
Bonheiden, , Belgium
Brugge, , Belgium
Berlin, , Germany
Erlangen, , Germany
Albuquerque, New Mexico, United States
Detroit, Michigan, United States
Fullerton, California, United States
Lincoln, Nebraska, United States
Cincinnati, Ohio, United States
Banska Bystrica, , Slovakia
Ljubljana, , Slovenia
Maribor, , Slovenia
St Gallen, , Switzerland
Los Angeles, California, United States
Baltimore, Maryland, United States
Muenchen, , Germany
Heidelberg, Victoria, Australia
Roma, Rm, Italy
Maitland, Florida, United States
San Diego, California, United States
Barcelona, , Spain
Izmir, , Turkey
West Palm Beach, Florida, United States
Firenze, Fi, Italy
Valencia, Comunidad Valenciana, Spain
Istanbul, Tur, Turkey
Mountain View, California, United States
Colorado Springs, Colorado, United States
Honolulu, Hawaii, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Tucuman, , Argentina
Liverpool, New South Wales, Australia
Tartu, , Estonia
Koeln, Nordrhein Westfalen, Germany
Swansea, , United Kingdom
Sunrise, Florida, United States
Newark, Delaware, United States
Plano, Texas, United States
Sevilla, Andalucia, Spain
Lugano, , Switzerland
Cardiff, , United Kingdom
Rosario, Santa Fe, Argentina
Ulm, , Germany
Indianapolis, Indiana, United States
Omaha, Nebraska, United States
Tampa, Florida, United States
Burnaby, British Columbia, Canada
Brno, Czech Republic, Czechia
Hollywood, Florida, United States
Hradec Kralove, Cze, Czechia
Beirut, , Lebanon
Pleven, , Bulgaria
Potsdam, , Germany
New Lambton Heights, New South Wales, Australia
Bergen, , Norway
Ashrafieh, , Lebanon
Cullman, Alabama, United States
Alzenau, , Germany
Unterhaching, , Germany
Cottbus, , Germany
Bratislava, , Slovakia
Trnava, , Slovakia
Havirov, Czech Republic, Czechia
Minden, , Germany
Verona, Vr, Italy
Larissa, Gr, Greece
Moscow, , Russian Federation
El Palmar, Murcia, Spain
Kosice, Slovak Republic, Slovakia
Porto, , Portugal
Sarasota, Florida, United States
Bielefeld, , Germany
Koln, , Germany
Edegem, Antwerpen, Belgium
Sofia, , Bulgaria
Jeddah, , Saudi Arabia
Izmir, , Turkey
Atlanta, Georgia, United States
Praha, , Czechia
Leipzig, , Germany
Osnabrück, , Germany
Siegen, , Germany
Thessaloniki, , Greece
Pecs, , Hungary
Katowice, , Poland
Santa Cruz De Tenerife, , Spain
Samsun, , Turkey
Trabzon, , Turkey
Loma Linda, California, United States
Amherst, New York, United States
Melbourne, Victoria, Australia
Maitland, Florida, United States
Westerstede/Oldenburg, , Germany
Nitra, , Slovakia
Riyadh, Sau, Saudi Arabia
Riga, Lv, Latvia
Trnava, , Slovakia
Chihuahua, , Mexico
Tucson, Arizona, United States
Miami, Florida, United States
Suwanee, Georgia, United States
Foxboro, Massachusetts, United States
Golden Valley, Minnesota, United States
Las Vegas, Nevada, United States
Philadelphia, Pennsylvania, United States
Buenos Aires, , Argentina
Tallinn, , Estonia
Lisboa, , Portugal
Thessaloniki, Gr, Greece
Oslo, , Norway
Wien, , Austria
Teplice, Czech Republic, Czechia
Budapest, Hun, Hungary
Kielce, , Poland
Braga, , Portugal
Barcelona, Cataluna, Spain
Fairfax, Virginia, United States
Linz, Oberoesterreich, Austria
Vigo, Pontevedra, Spain
Mexico, Distrito Federal, Mexico
Tartu, , Estonia
Ciudad De Mexico, Distrito Federal, Mexico
Plymouth, Devon, United Kingdom
Woodmere, New York, United States
Bielefeld, , Germany
Drammen, , Norway
Wroclaw, , Poland
Loures, , Portugal
St Petersburg, , Russian Federation
Westerville, Ohio, United States
Bydgoszcz, Woj Kujawsko Pomorskie, Poland
Brno, , Czechia
Morelia, Michoacan, Mexico
Chesaning, Michigan, United States
Woodmere, New York, United States
Pittsburgh, Pennsylvania, United States
Esneux, , Belgium
Thessaloniki, , Greece
Tatabanya, Komarom Esztergom, Hungary
Sancaktepe, Istanbul, Turkey
Miami, Florida, United States
Atlanta, Georgia, United States
Buenos Aires, , Argentina
Fairfax, Virginia, United States
Beirut, , Lebanon
Swansea, , United Kingdom
Westerstede Oldenburg, , Germany
Cleveland, Ohio, United States
Greece, , Greece
Suwanee, Georgia, United States
Tampa, Florida, United States
Las Vegas, Nevada, United States
Aurora, Colorado, United States
Sarasota, Florida, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Plano, Texas, United States
Fairfax, Virginia, United States
Milwaukee, Wisconsin, United States
Osnabrueck, Niedersachsen, Germany
Fullerton, California, United States
Westerville, Ohio, United States
Havirov, , Czechia
Teplice, , Czechia
Homestead, Florida, United States
Oslo, , Norway
Baltimore, Maryland, United States
Karachi, , Slovakia
Cottbus, Brandenburg, Germany
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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