Phase
Condition
Multiple Sclerosis
Neurologic Disorders
Memory Loss
Treatment
Ofatumumab
Clinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants eligible for inclusion in this study must meet all of the following criteria:
Written informed consent must be obtained before any assessment is performed.
Male or female participants aged 18 to 60 years (inclusive) at screening.
Diagnosis of relapsing MS (RMS) according to the 2017 Revised McDonald criteria (Thompson et al. 2018), including CIS, RRMS or SPMS with disease activity as definedby (Lublin et al. 2014).
Disability status at Screening with an EDSS score of 0 to 5.5 (inclusive).
Received at least 2 courses of intravenous aCD20 mAb (loading doses are considered 1course):
• Participants currently treated with ocrelizumab must have received (meet all threecriteria below):
- 2 fully infused initial 300 mg ocrelizumab iv infusions 2. At least 1 fully infused 600 mg ocrelizumab iv infusions 6 months (+/- one month) 3. Last fully infusedocrelizumab dose must have occurred within 4-9 months prior to baseline
•Participants currently treated with rituximab must have received (meet both criteria below):
At least 2 fully infused courses of rituximab 500 mg - 1000 mg iv every 6 months (+/- one month).
Initial loading regimens of rituximab i.e. 500 mg - 1000 mg on day 1 and on day 15, are allowed but this is consider a single course and must be followed byadditional infusion(s) every 6 months (+/- one month)
Last fully infused rituximab dose must have occurred within 4-9 months prior tobaseline.
Participants discontinuing aCD20 therapy for reasons including, but not limited to:physician/participant preference, access to commercial drug (e.g. insurance coverageissues) or for other logistical reasons (such as geographical relocation, travel,etc.) are eligible for this study. 7. Neurologically stable within 1 month prior tofirst study drug administration.
Must be able to use a smart device or have a caregiver that can assist.
Exclusion
Exclusion Criteria:
Participants meeting any of the following criteria are not eligible for inclusion in this study:
- Participants that have demonstrated suboptimal response to aCD20 therapy to include: a. Signs of MRI activity, defined as ≥ 2 active Gd+ T1 lesions, or any new or newlyenlarging T2 lesions, documented within the past 6 months
If a prior MRI within the last 6 months is not available, then new or newlyenlarging T2 lesions should be considered "not documented" and the patient maycontinue screening b. Documented relapse while on stable, previous aCD20treatment.
Relapses during the first 3 months of intravenous aCD20 therapy are allowableif the participant is then relapse-free for the 12 months following the relapsewhile on intravenous aCD20 therapy c. Any signs of clinical worsening asmeasured by EDSS or any clinical measure documented within the last 6 months
Discontinuing aCD20 mAb therapy due to the following treatment- emergent adverseevents:
Severe infusion-related reactions (Grade 3 or above)
Recurrent infections defined as ≥ 2 severe infections or ≥ 3 respiratoryinfections or the need for ≥ 2 courses of antibiotics since starting aCD20therapy, if the Investigator believes this is related to therapy.
Decreased IgG requiring treatment with Intravenous immunoglobulin
Participants with primary progressive MS (Polman et al 2011) or SPMS without diseaseactivity (Lublin et al 2014).
Participants meeting criteria for neuromyelitis optica (Wingerchuk et al 2015).
Pregnant or nursing (lactating) women
Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, unless they are using highly effective methods of contraceptionduring dosing and for at least 6 months after stopping study medication.
Participants with active chronic disease (or stable but treated with immune therapy)of the immune system other than MS (e.g. rheumatoid arthritis, scleroderma,Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or withimmunodeficiency syndrome (hereditary immune deficiency, drug-induced immunedeficiency).
Participants with active systemic bacterial, viral or fungal infections, or known tohave acquired immunodeficiency syndrome (AIDS).
Participants with neurological symptoms consistent with PML or with confirmed PML.
Participants at risk of developing or having reactivation of syphilis ortuberculosis
Participants at risk of developing or having reactivation of hepatitis.
Have received any live or live-attenuated vaccines (including for varicella-zostervirus or measles) within 4 weeks prior to first study drug administration. a. Thereis presently no contraindication for the use of an inactivated, viral-vector-or mRNAbased Sars-CoV-2 vaccine in patients who are immunocompromised. However, differentSars-CoV-2 vaccines may have various mechanisms of action and different associatedpotential risks. Please review local prescribing information of any specificSars-CoV-2 vaccine and comply with local prescribing information requirements forspecific contra-indications and special warnings and precautions for use.
Study Design
Study Description
Connect with a study center
Caribbean Center for Clinical Research, Inc
Guaynabo, 00968
Puerto RicoSite Not Available
Caribbean Center for Clinical Research, Inc .
Guaynabo, 00968
Puerto RicoSite Not Available
Caribbean Center for Clinical Research, Inc. .
Guaynabo, 00968
Puerto RicoSite Not Available
Caribbean Ctr for Clin Resch Inc .
Guaynabo, 00968
Puerto RicoSite Not Available
Novartis Investigative Site
Guaynabo, 00968
Puerto RicoSite Not Available
Alabama Neurology Associates PC
Birmingham, Alabama 35209
United StatesSite Not Available
Alabama Neurology Associates PC Neurology
Birmingham, Alabama 35209
United StatesSite Not Available
Alabama Neurology Associates PC Suite 105
Birmingham, Alabama 35209
United StatesSite Not Available
Novartis Investigative Site
Birmingham, Alabama 35209
United StatesSite Not Available
Ctr for Neurology and Spine
Phoenix, Arizona 85018
United StatesSite Not Available
Novartis Investigative Site
Phoenix, Arizona 85018
United StatesSite Not Available
Novartis Investigative Site
Encinitas, California 92024
United StatesSite Not Available
The Research Center of Southern California .
Encinitas, California 92024
United StatesSite Not Available
Novartis Investigative Site
La Jolla, California 92037
United StatesSite Not Available
University of California San Diego UCSD ACTRI
La Jolla, California 92037
United StatesSite Not Available
Neuro Center
Pomona, California 91767
United StatesSite Not Available
Novartis Investigative Site
Pomona, California 91767
United StatesSite Not Available
Lightship
Torrance, California 90505
United StatesSite Not Available
Novartis Investigative Site
Torrance, California 90505
United StatesSite Not Available
Novartis Investigative Site
Aurora, Colorado 80045
United StatesSite Not Available
UC Health Neuroscience Ctr
Aurora, Colorado 80045
United StatesSite Not Available
Infinity Clinical Research LLC
Hollywood, Florida 33024
United StatesSite Not Available
Neurology Associates of Ormond Beach
Ormond Beach, Florida 32174
United StatesSite Not Available
Novartis Investigative Site
Ormond Beach, Florida 32174
United StatesSite Not Available
Novartis Investigative Site
Sunrise, Florida 33351
United StatesSite Not Available
AMO Corporation
Tallahassee, Florida 32312
United StatesSite Not Available
AMO Corporation .
Tallahassee, Florida 32312
United StatesSite Not Available
Novartis Investigative Site
Tallahassee, Florida 32312
United StatesSite Not Available
Novartis Investigative Site
Tampa, Florida 33612
United StatesSite Not Available
University Of South Florida
Tampa, Florida 33612
United StatesSite Not Available
University Of South Florida .
Tampa, Florida 33612
United StatesSite Not Available
International Neurorehab Institute
Lutherville, Maryland 21093
United StatesSite Not Available
Novartis Investigative Site
Lutherville, Maryland 21093
United StatesSite Not Available
Beth Israel Deaconess Medical Cente
Boston, Massachusetts 02215
United StatesSite Not Available
Dana Farber Cancer Institute
Boston, Massachusetts 02115
United StatesSite Not Available
Dana Farber Cancer Institute Main Centre
Boston, Massachusetts 02115
United StatesSite Not Available
Novartis Investigative Site
Boston, Massachusetts 02215
United StatesSite Not Available
Neurology Center of New England PC
Foxboro, Massachusetts 02035
United StatesSite Not Available
Neurology Center of New England PC .
Foxboro, Massachusetts 02035
United StatesSite Not Available
Novartis Investigative Site
Foxboro, Massachusetts 02035
United StatesSite Not Available
Dragonfly Research LLC
Wellesley, Massachusetts 02481
United StatesSite Not Available
Dragonfly Research LLC Elliott Lewis Center
Wellesley, Massachusetts 02481
United StatesSite Not Available
Novartis Investigative Site
Wellesley, Massachusetts 02481
United StatesSite Not Available
Novartis Investigative Site
Golden Valley, Minnesota 55422
United StatesSite Not Available
Minnesota Center Multiple Sclerosis
Plymouth, Minnesota 55446
United StatesSite Not Available
Novartis Investigative Site
Plymouth, Minnesota 55446
United StatesSite Not Available
Cleveland Clinic Foundation
Las Vegas, Nevada 89106
United StatesSite Not Available
Novartis Investigative Site
Las Vegas, Nevada 89106
United StatesSite Not Available
Ms Ctr Of Northeastern Ny
Latham, New York 12110
United StatesSite Not Available
Novartis Investigative Site
Latham, New York 12110
United StatesSite Not Available
Novartis Investigative Site
Canton, Ohio 44718
United StatesSite Not Available
Columbus Neuroscience
Westerville, Ohio 43082
United StatesSite Not Available
Columbus Neuroscience Columbus Neuroscience LLC
Westerville, Ohio 43082
United StatesSite Not Available
Novartis Investigative Site
Westerville, Ohio 43082
United StatesSite Not Available
Hope Neurology
Knoxville, Tennessee 37922
United StatesSite Not Available
Hope Neurology .
Knoxville, Tennessee 37922
United StatesSite Not Available
Novartis Investigative Site
Knoxville, Tennessee 37922
United StatesSite Not Available
Sibyl Wray MD Neurology PC
Knoxville, Tennessee 37922
United StatesSite Not Available
Novartis Investigative Site
Dallas, Texas 75325
United StatesSite Not Available
Parkland Health and Hospital Systems
Dallas, Texas 75325
United StatesSite Not Available
Central TX Neuro Consultants P A
Round Rock, Texas 78681
United StatesSite Not Available
Central TX Neuro Consultants P A .
Round Rock, Texas 78681
United StatesSite Not Available
Central Texas Neurology Consultants P A .
Round Rock, Texas 78681
United StatesCompleted
Novartis Investigative Site
Round Rock, Texas 78681
United StatesSite Not Available
Novartis Investigative Site
Seattle, Washington 98122
United StatesSite Not Available
Swedish Neuroscience Institute
Seattle, Washington 98122
United StatesSite Not Available
Swedish Neuroscience Institute MS Center
Seattle, Washington 98122
United StatesSite Not Available
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