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

Completed · Phase 3

Conditions studied: Relapsing Multiple Sclerosis

In brief

Open-label study to evaluate the effectiveness of treatment with ofatumumab in subjects transitioning from any fumarate-based RMS approved therapy or fingolimod due to breakthrough disease.

Key facts

Study ID

NCT04353492

Run by

Novartis Pharmaceuticals

People needed

562

Starts

2020-07-14

Expected to finish

2025-03-11

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CU Anschutz Med Campus — Aurora, Colorado, United States
• Christiana Care Health Services — Newark, Delaware, United States
• Memorial Healthcare System — Hollywood, Florida, United States
• Homestead Assoc In Research Inc — Homestead, Florida, United States
• Neurology Associates PA — Maitland, Florida, United States
• UM Department Of Neurology — Miami, Florida, United States
• Negroski Neurology — Sarasota, Florida, United States
• Axiom Clinical Research of Florida — Tampa, Florida, United States
• University Of South Florida — Tampa, Florida, United States
• Premiere Research Institute — West Palm Beach, Florida, United States
• Atlanta Neuroscience Institute — Atlanta, Georgia, United States
• Georgia Neurology and Sleep Medicine Assoc — Suwanee, Georgia, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Cleveland Clinic Foundation — Las Vegas, Nevada, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Five Towns Neuroscience Research — Woodmere, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Columbus Neuroscience — Westerville, Ohio, United States
• Multiple Sclerosis Center of Excellence of OMRF — Oklahoma City, Oklahoma, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• Saturn Research Solutions LLC — Plano, Texas, United States
• INOVA Medical Group — Fairfax, Virginia, United States
• Ascension St Francis Center — Milwaukee, Wisconsin, United States
• Fullerton Neuro and Headache Ctr — Fullerton, California, United States

Full record on ClinicalTrials.gov

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