Multiple Sclerosis Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

564

Study ID:

NCT04353492

Recruitment Status:

Active, not recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 121 Locations for this study

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Fullerton Neuro and Headache Ctr
Fullerton California, 92835, United States
CU Anschutz Med Campus
Aurora Colorado, 80045, United States
Christiana Care Health Services
Newark Delaware, 19713, United States
Memorial Hospital
Hollywood Florida, 33021, United States
Neurology Associates, PA
Maitland Florida, 32751, United States
Homestead Associates in Research Inc
Miami Florida, 33032, United States
University of Miami Miller School of Medicine
Miami Florida, 33136, United States
Negroski Neurology
Sarasota Florida, 34233, United States
Axiom Clinical Research of Florida
Tampa Florida, 33609, United States
University of South Florida .
Tampa Florida, 33612, United States
Premiere Research Institute
West Palm Beach Florida, 33407, United States
Atlanta Neuroscience Institute
Atlanta Georgia, 30327, United States
Georgia Neurology and Sleep Medicine Assoc
Suwanee Georgia, 30024, United States
Johns Hopkins MS Center
Baltimore Maryland, 21287, United States
Cleveland Clinic Foundation
Las Vegas Nevada, 89106, United States
University of New Mexico
Albuquerque New Mexico, 87131, United States
Novartis Investigative Site
Woodmere New York, 11598, United States
Cleveland Clinic Foundation .
Cleveland Ohio, 44195, United States
Novartis Investigative Site
Westerville Ohio, 43082, United States
Multiple Sclerosis Center of Excellence of OMRF
Oklahoma City Oklahoma, 73104, United States
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States
Baylor College of Medicine
Houston Texas, 77030, United States
North TX Inst of Neuro and Headache
Plano Texas, 75024, United States
INOVA Medical Group .
Fairfax Virginia, 22030, United States
Ascension St Francis Center
Milwaukee Wisconsin, 53215, United States
Novartis Investigative Site
Rosario Santa Fe, S2000, Argentina
Novartis Investigative Site
Rosario Santa Fe, S2000, Argentina
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Buenos Aires , C1424, Argentina
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Tucuman , 4000, Argentina
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New Lambton Heights New South Wales, 2305, Australia
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Woolloongabba Queensland, 4102, Australia
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Parkville Victoria, 3050, Australia
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Linz Oberoesterreich, A 402, Austria
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Linz , 4020, Austria
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Vienna , 1090, Austria
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Wien , 1010, Austria
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Edegem Antwerpen, 2650, Belgium
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Brugge , 8000, Belgium
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Bruxelles , 1200, Belgium
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Pleven , 5800, Bulgaria
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Sofia , 1113, Bulgaria
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Sofia , 1413, Bulgaria
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Sofia , 1431, Bulgaria
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Toronto Ontario, M4N 3, Canada
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Brno Czech Republic, 656 9, Czechia
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Havirov Czech Republic, 736 0, Czechia
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Teplice Czech Republic, 415 0, Czechia
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Hradec Kralove CZE, 500 0, Czechia
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Praha , 12808, Czechia
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Tallinn , 11315, Estonia
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Tartu , 50406, Estonia
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Bielefeld , D 336, Germany
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Cottbus , 03048, Germany
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Heidelberg , 69120, Germany
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Koln , 50935, Germany
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Leipzig , 04275, Germany
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Muenchen , 81377, Germany
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Osnabrück , 49076, Germany
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Potsdam , 14471, Germany
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Siegen , 57076, Germany
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Ulm , 89073, Germany
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Ulm , 89081, Germany
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Westerstede Oldenburg , 26655, Germany
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Larissa GR, 411 1, Greece
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Greece , 53246, Greece
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Thessaloniki , GR 54, Greece
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Budapest HUN, 1135, Hungary
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Budapest , 1138, Hungary
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Budapest , 1204, Hungary
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Pecs , 7623, Hungary
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Firenze FI, 50134, Italy
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Pavia PV, 27100, Italy
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Roma RM, 00152, Italy
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Verona VR, 37134, Italy
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Riga LV, LV-10, Latvia
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Riga , LV 10, Latvia
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Ashrafieh , 16683, Lebanon
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Beirut , 10999, Lebanon
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Beirut , 1107 , Lebanon
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Beirut , 8610, Lebanon
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Ciudad de Mexico Distrito Federal, 06700, Mexico
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Mexico Distrito Federal, 03100, Mexico
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Morelia Michoacan, 58260, Mexico
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Oslo , NO 04, Norway
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Bydgoszcz Woj Kujawsko-pomorskie, 85-79, Poland
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Katowice , 40 57, Poland
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Kielce , 25 72, Poland
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Lodz , 90-15, Poland
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Wroclaw , 51-68, Poland
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Braga , 47102, Portugal
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Lisboa , 1349-, Portugal
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Loures , 26745, Portugal
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Porto , 4099-, Portugal
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Moscow , 11551, Russian Federation
Novartis Investigative Site
Moscow , 12701, Russian Federation
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St Petersburg , 19000, Russian Federation
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Riyadh SAU, 11525, Saudi Arabia
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Jeddah , 21499, Saudi Arabia
Novartis Investigative Site
Kosice Slovak Republic, 04066, Slovakia
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Banska Bystrica , 975 1, Slovakia
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Bratislava , 813 6, Slovakia
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Bratislava , 82606, Slovakia
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Bratislava , 83305, Slovakia
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Nitra , 94901, Slovakia
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Trnava , 917 7, Slovakia
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Ljubljana , 1000, Slovenia
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Maribor , 2000, Slovenia
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Sevilla Andalucia, 41009, Spain
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Barcelona Cataluna, 08026, Spain
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Valencia Comunidad Valenciana, 46010, Spain
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El Palmar Murcia, 30120, Spain
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Baracaldo Vizcaya, 48903, Spain
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Madrid , 28040, Spain
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Santa Cruz de Tenerife , 38009, Spain
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Valencia , 46026, Spain
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Basel , 4031, Switzerland
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Sancaktepe Istanbul, 34785, Turkey
Novartis Investigative Site
Istanbul TUR, 34098, Turkey
Novartis Investigative Site
Izmir , 35040, Turkey
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Samsun , 55139, Turkey
Novartis Investigative Site
Trabzon , 61080, Turkey
Novartis Investigative Site
Cardiff , CF14 , United Kingdom
Novartis Investigative Site
Swansea , SA12 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

564

Study ID:

NCT04353492

Recruitment Status:

Active, not recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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