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
- Registration Number
- NCT04353492
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 562
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ofatumumab Ofatumumab Ofatumumab 20 mg subcutaneous injections every 4 weeks, following loading of 3 doses in the first 14 days
- Primary Outcome Measures
Name Time Method Annual Relapse Rate (ARR) Up to 96 weeks from baseline ARR is the number of confirmed relapses in a year calculated based on cumulative number of relapses by patient adjusted for time-in-study by patient
- Secondary Outcome Measures
Name Time Method Safety evaluation 96 weeks Proportion of patients with adverse events, including injection related reactions, abnormal laboratory results or vital signs, as well as proportion of patients discontinuing treatment due to insufficient effectiveness or tolerability/safety reasons
Trial Locations
- Locations (25)
Fullerton Neuro and Headache Ctr
🇺🇸Fullerton, California, United States
CU Anschutz Med Campus
🇺🇸Aurora, Colorado, United States
Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Memorial Hospital
🇺🇸Hollywood, Florida, United States
Homestead Assoc In Research Inc
🇺🇸Homestead, Florida, United States
Neurology Associates PA
🇺🇸Maitland, Florida, United States
University of Miami Miller School of Medicine
🇺🇸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
🇺🇸Cleveland, Ohio, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Five Towns Neuroscience Research
🇺🇸Woodmere, New York, 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
North TX Inst of Neuro and Headache
🇺🇸Plano, Texas, United States
INOVA Medical Group
🇺🇸Fairfax, Virginia, United States
Ascension St Francis Center
🇺🇸Milwaukee, Wisconsin, United States
Novartis Investigative Site
🇬🇧Swansea, United Kingdom