Phase
Condition
Multiple Sclerosis
Scar Tissue
Memory Loss
Treatment
Ofatumumab
Clinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
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), whereall fumarates are considered as one DMT
Subject transitioning from either any fumarate-based RMS approved therapies, such asdimethyl fumarate (DMF) or diroximel fumarate (DRF), or fingolimod which wasadministered for a period of at least 6 months, as their last DMT before first studydrug administration
Breakthrough disease activity while the participant was adequately using fumaratesor fingolimod prior to transitioning for a minimum of 6 months as evidenced by oneor more clinically reported relapses or one or more signs of Magnetic ResonanceImaging (MRI) activity (e.g. Gd+ enhancement, new or enlarging T2 lesions)
Neurologically stable within one month prior to first study drug administration
Exclusion
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 ofcontraception during dosing and for at least 6 months after stopping studymedication
Subjects with active chronic disease of the immune system other than MS or withimmunodeficiency syndrome
Subjects with active systemic bacterial, fungal or viral infections (such ashepatitis, HIV, COVID-19), or known to have Acquired Immunodeficiency Syndrome (AIDS)
Subjects with neurological symptoms consistent with Progressive MultifocalLeukoencephalopathy (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 latenttuberculosis, even if previously treated), as confirmed by medical history or perlocal practice
Subjects with active hepatitis B and C disease, assessed locally
Have received any live or live-attenuated vaccines within 4 weeks prior to firststudy 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 studyprotocol requirements in the opinion of the investigator
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Caba, Buenos Aires C1424BYD
ArgentinaSite Not Available
Novartis Investigative Site
Rosario, Santa Fe S2000BZL
ArgentinaSite Not Available
Novartis Investigative Site
Buenos Aires, C1424BYD
ArgentinaSite Not Available
Novartis Investigative Site
Tucuman, 4000
ArgentinaSite Not Available
Novartis Investigative Site
Liverpool, New South Wales 2170
AustraliaSite Not Available
Novartis Investigative Site
New Lambton Heights, New South Wales 2305
AustraliaSite Not Available
Novartis Investigative Site
Woolloongabba, Queensland 4102
AustraliaSite Not Available
Novartis Investigative Site
Melbourne, Victoria 3004
AustraliaSite Not Available
Novartis Investigative Site
Parkville, Victoria 3050
AustraliaSite Not Available
Novartis Investigative Site
Nedlands, Western Australia 6009
AustraliaSite Not Available
Novartis Investigative Site
Linz, 4020
AustriaSite Not Available
Novartis Investigative Site
Vienna, 1090
AustriaSite Not Available
Novartis Investigative Site
Wien, 1010
AustriaSite Not Available
Novartis Investigative Site
Bonheiden, 2820
BelgiumSite Not Available
Novartis Investigative Site
Brugge, 8000
BelgiumSite Not Available
Novartis Investigative Site
Bruxelles, 1200
BelgiumSite Not Available
Novartis Investigative Site
Edegem, 2650
BelgiumSite Not Available
Novartis Investigative Site
Esneux, 4130
BelgiumSite Not Available
Novartis Investigative Site
Pleven, 5800
BulgariaSite Not Available
Novartis Investigative Site
Sofia, 1431
BulgariaSite Not Available
Novartis Investigative Site
Burnaby, British Columbia V5G 2X6
CanadaSite Not Available
Novartis Investigative Site
Toronto, Ontario M4N 3M5
CanadaSite Not Available
Novartis Investigative Site
Hradec Kralove, CZE 500 05
CzechiaSite Not Available
Novartis Investigative Site
Brno, 60200
CzechiaSite Not Available
Novartis Investigative Site
Havirov, 736 01
CzechiaSite Not Available
Novartis Investigative Site
Praha, 12808
CzechiaSite Not Available
Novartis Investigative Site
Teplice, 415 01
CzechiaSite Not Available
Novartis Investigative Site
Tallinn, 11315
EstoniaSite Not Available
Novartis Investigative Site
Tartu, 50406
EstoniaSite Not Available
Novartis Investigative Site
Regensburg, Bavaria 93053
GermanySite Not Available
Novartis Investigative Site
Cottbus, Brandenburg 03048
GermanySite Not Available
Novartis Investigative Site
Osnabrueck, Niedersachsen 49076
GermanySite Not Available
Novartis Investigative Site
Koeln, Nordrhein-Westfalen 50935
GermanySite Not Available
Novartis Investigative Site
Alzenau, 63755
GermanySite Not Available
Novartis Investigative Site
Berlin, 10713
GermanySite Not Available
Novartis Investigative Site
Bielefeld, 33647
GermanySite Not Available
Novartis Investigative Site
Erlangen, 91054
GermanySite Not Available
Novartis Investigative Site
Heidelberg, 69120
GermanySite Not Available
Novartis Investigative Site
Koln, 50935
GermanySite Not Available
Novartis Investigative Site
Leipzig, 04275
GermanySite Not Available
Novartis Investigative Site
Minden, 32429
GermanySite Not Available
Novartis Investigative Site
Muenchen, 81377
GermanySite Not Available
Novartis Investigative Site
Osnabrück, 49076
GermanySite Not Available
Novartis Investigative Site
Potsdam, 14471
GermanySite Not Available
Novartis Investigative Site
Siegen, 57076
GermanySite Not Available
Novartis Investigative Site
Ulm, 89081
GermanySite Not Available
Novartis Investigative Site
Unterhaching, 82008
GermanySite Not Available
Novartis Investigative Site
Westerstede Oldenburg, 26655
GermanySite Not Available
Novartis Investigative Site
Westerstede/Oldenburg, 26655
GermanySite Not Available
Novartis Investigative Site
Larissa, GR 411 10
GreeceSite Not Available
Novartis Investigative Site
Amyntaio, 53246
GreeceSite Not Available
Novartis Investigative Site
Greece, 53246
GreeceSite Not Available
Novartis Investigative Site
Thessaloniki, GR 54636
GreeceSite Not Available
Novartis Investigative Site
Budapest, HUN 1135
HungarySite Not Available
Novartis Investigative Site
Tatabanya, Komarom Esztergom 2800
HungarySite Not Available
Novartis Investigative Site
Pecs, 7623
HungarySite Not Available
Novartis Investigative Site
Firenze, FI 50134
ItalySite Not Available
Novartis Investigative Site
Pavia, PV 27100
ItalySite Not Available
Novartis Investigative Site
Roma, RM 00152
ItalySite Not Available
Novartis Investigative Site
Verona, VR 37134
ItalySite Not Available
Novartis Investigative Site
Riga, LV 1002
LatviaSite Not Available
Novartis Investigative Site
Ashrafieh, 166830
LebanonSite Not Available
Novartis Investigative Site
Beirut, 8610
LebanonSite Not Available
Novartis Investigative Site
Ciudad de Mexico, Distrito Federal 06700
MexicoSite Not Available
Novartis Investigative Site
Mexico, Distrito Federal 03100
MexicoSite Not Available
Novartis Investigative Site
Morelia, Michoacan 58260
MexicoSite Not Available
Novartis Investigative Site
Chihuahua, 31203
MexicoSite Not Available
Novartis Investigative Site
Bergen, 5021
NorwaySite Not Available
Novartis Investigative Site
Drammen, 1086
NorwaySite Not Available
Novartis Investigative Site
Oslo, NO-0407
NorwaySite Not Available
Novartis Investigative Site
Bydgoszcz, Woj Kujawsko-pomorskie 85-796
PolandSite Not Available
Novartis Investigative Site
Katowice, 40 571
PolandSite Not Available
Novartis Investigative Site
Kielce, 25 726
PolandSite Not Available
Novartis Investigative Site
Lodz, 90-153
PolandSite Not Available
Novartis Investigative Site
Wroclaw, 51-685
PolandSite Not Available
Novartis Investigative Site
Braga, 4710243
PortugalSite Not Available
Novartis Investigative Site
Lisboa, 1349-019
PortugalSite Not Available
Novartis Investigative Site
Loures, 2674514
PortugalSite Not Available
Novartis Investigative Site
Porto, 4099-001
PortugalSite Not Available
Novartis Investigative Site
Moscow, 115516
Russian FederationSite Not Available
Novartis Investigative Site
St Petersburg, 190000
Russian FederationSite Not Available
Novartis Investigative Site
Riyadh, SAU 11525
Saudi ArabiaSite Not Available
Novartis Investigative Site
Jeddah, 21499
Saudi ArabiaSite Not Available
Novartis Investigative Site
Banska Bystrica, 975 17
SlovakiaSite Not Available
Novartis Investigative Site
Bratislava, 813 69
SlovakiaSite Not Available
Novartis Investigative Site
Karachi, 75230
SlovakiaSite Not Available
Novartis Investigative Site
Kosice, 041 90
SlovakiaSite Not Available
Novartis Investigative Site
Nitra, 94901
SlovakiaSite Not Available
Novartis Investigative Site
Trnava, 91702
SlovakiaSite Not Available
Novartis Investigative Site
Ljubljana, 1000
SloveniaSite Not Available
Novartis Investigative Site
Maribor, 2000
SloveniaSite Not Available
Novartis Investigative Site
Sevilla, Andalucia 41009
SpainSite Not Available
Novartis Investigative Site
Valencia, Comunidad Valenciana 46010
SpainSite Not Available
Novartis Investigative Site
El Palmar, Murcia 30120
SpainSite Not Available
Novartis Investigative Site
Vigo, Pontevedra 36212
SpainSite Not Available
Novartis Investigative Site
Baracaldo, Vizcaya 48903
SpainSite Not Available
Novartis Investigative Site
Barcelona, 08041
SpainSite Not Available
Novartis Investigative Site
Madrid, 28040
SpainSite Not Available
Novartis Investigative Site
Santa Cruz de Tenerife, 38009
SpainSite Not Available
Novartis Investigative Site
Basel, 4031
SwitzerlandSite Not Available
Novartis Investigative Site
Lugano, 6900
SwitzerlandSite Not Available
Novartis Investigative Site
St Gallen, 9007
SwitzerlandSite Not Available
Novartis Investigative Site
Sancaktepe, Istanbul 34785
TurkeySite Not Available
Novartis Investigative Site
Istanbul, TUR 34098
TurkeySite Not Available
Novartis Investigative Site
Izmir, 35100
TurkeySite Not Available
Novartis Investigative Site
Samsun, 55139
TurkeySite Not Available
Novartis Investigative Site
Trabzon, 61080
TurkeySite Not Available
Novartis Investigative Site
Plymouth, Devon PL6 8BT
United KingdomSite Not Available
Novartis Investigative Site
Cardiff, CF14 4XW
United KingdomSite Not Available
Novartis Investigative Site
Swansea, SA2 8QA
United KingdomSite Not Available
Novartis Investigative Site
Cullman, Alabama 35058
United StatesSite Not Available
Novartis Investigative Site
Tucson, Arizona 85718
United StatesSite Not Available
Fullerton Neuro and Headache Ctr
Fullerton, California 92835
United StatesSite Not Available
Fullerton Neurology and Headache Center
Fullerton, California 92835
United StatesSite Not Available
Novartis Investigative Site
Fullerton, California 92835
United StatesSite Not Available
Novartis Investigative Site
Loma Linda, California 92354
United StatesSite Not Available
Novartis Investigative Site
Los Angeles, California 90033
United StatesSite Not Available
Novartis Investigative Site
Mountain View, California 94040
United StatesSite Not Available
Novartis Investigative Site
San Diego, California 92103
United StatesSite Not Available
CU Anschutz Med Campus
Aurora, Colorado 80045
United StatesSite Not Available
Novartis Investigative Site
Aurora, Colorado 80045
United StatesSite Not Available
Novartis Investigative Site
Colorado Springs, Colorado 80907
United StatesSite Not Available
Christiana Care Health Services
Newark, Delaware 19713
United StatesSite Not Available
Novartis Investigative Site
Newark, Delaware 19713
United StatesSite Not Available
Memorial Hospital
Hollywood, Florida 33021
United StatesSite Not Available
Novartis Investigative Site
Hollywood, Florida 33021
United StatesSite Not Available
Homestead Assoc In Research Inc
Homestead, Florida 33033
United StatesSite Not Available
Neurology Associates PA
Maitland, Florida 32751
United StatesSite Not Available
Neurology Associates, PA
Maitland, Florida 32751
United StatesSite Not Available
Novartis Investigative Site
Maitland, Florida 32751
United StatesSite Not Available
Homestead Associates in Research Inc
Miami, Florida 33032
United StatesSite Not Available
Novartis Investigative Site
Miami, Florida 33136
United StatesSite Not Available
University of Miami Miller School of Medicine
Miami, Florida 33136
United StatesSite Not Available
Negroski Neurology
Sarasota, Florida 34233
United StatesSite Not Available
Novartis Investigative Site
Sarasota, Florida 34233
United StatesSite Not Available
Novartis Investigative Site
Sunrise, Florida 33351
United StatesSite Not Available
Axiom Clinical Research of Florida
Tampa, Florida 33609
United StatesSite Not Available
Novartis Investigative Site
Tampa, Florida 33609
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
Novartis Investigative Site
West Palm Beach, Florida 33407
United StatesSite Not Available
Premiere Research Institute
West Palm Beach, Florida 33407
United StatesSite Not Available
Atlanta Neuroscience Institute
Atlanta, Georgia 30327
United StatesSite Not Available
Novartis Investigative Site
Atlanta, Georgia 30327
United StatesSite Not Available
Georgia Neurology and Sleep Medicine Assoc
Suwanee, Georgia 30024
United StatesSite Not Available
Novartis Investigative Site
Suwanee, Georgia 30024
United StatesSite Not Available
Novartis Investigative Site
Honolulu, Hawaii 96817
United StatesSite Not Available
Novartis Investigative Site
Indianapolis, Indiana 46256
United StatesSite Not Available
Johns Hopkins Hospital
Baltimore, Maryland 21287
United StatesSite Not Available
Johns Hopkins Hospital Johns Hopkins Hospital
Baltimore, Maryland 21287
United StatesSite Not Available
Johns Hopkins MS Center
Baltimore, Maryland 21287
United StatesSite Not Available
Novartis Investigative Site
Baltimore, Maryland 21287
United StatesSite Not Available
Novartis Investigative Site
Boston, Massachusetts 02114
United StatesSite Not Available
Novartis Investigative Site
Foxboro, Massachusetts 02035
United StatesSite Not Available
Novartis Investigative Site
Chesaning, Michigan 48616
United StatesSite Not Available
Novartis Investigative Site
Detroit, Michigan 48202
United StatesSite Not Available
Novartis Investigative Site
Golden Valley, Minnesota 55422
United StatesSite Not Available
Novartis Investigative Site
Lincoln, Nebraska 68510
United StatesSite Not Available
Novartis Investigative Site
Omaha, Nebraska 68131
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
Novartis Investigative Site
Albuquerque, New Mexico 87131-0001
United StatesSite Not Available
University of New Mexico
Albuquerque, New Mexico 87131-0001
United StatesSite Not Available
Novartis Investigative Site
Amherst, New York 14226
United StatesSite Not Available
Five Towns Neuroscience Research
Woodmere, New York 11598
United StatesSite Not Available
Novartis Investigative Site
Woodmere, New York 11598
United StatesSite Not Available
Novartis Investigative Site
Cincinnati, Ohio 45219
United StatesSite Not Available
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
Cleveland Clinic Foundation .
Cleveland, Ohio 44195
United StatesSite Not Available
Novartis Investigative Site
Cleveland, Ohio 44195
United StatesSite Not Available
Columbus Neuroscience
Westerville, Ohio 43082
United StatesSite Not Available
Novartis Investigative Site
Westerville, Ohio 43082
United StatesSite Not Available
Multiple Sclerosis Center of Excellence of OMRF
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Novartis Investigative Site
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Novartis Investigative Site
Portland, Oregon 97225
United StatesSite Not Available
Novartis Investigative Site
Philadelphia, Pennsylvania 19107-5098
United StatesSite Not Available
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107-5098
United StatesSite Not Available
Novartis Investigative Site
Pittsburgh, Pennsylvania 15240
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available
Novartis Investigative Site
Houston, Texas 77030
United StatesSite Not Available
North TX Inst of Neuro and Headache
Plano, Texas 75024
United StatesSite Not Available
Novartis Investigative Site
Plano, Texas 75024
United StatesSite Not Available
INOVA Medical Group
Fairfax, Virginia 22030
United StatesSite Not Available
INOVA Medical Group .
Fairfax, Virginia 22030
United StatesSite Not Available
Novartis Investigative Site
Fairfax, Virginia 22030
United StatesSite Not Available
Ascension St Francis Center
Milwaukee, Wisconsin 53215
United StatesSite Not Available
Novartis Investigative Site
Milwaukee, Wisconsin 53215
United StatesSite Not Available
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