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Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS
Sponsor: Novartis Pharmaceuticals
Summary
The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study. Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS). COVID-19 sub-study: The purpose of this research sub-study is to explore the immune response following Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination in a subset of subjects on long-term ofatumumab 20 mg sc. Note: Novartis is not supplying the SARS-CoV-2 vaccine.
Official title: An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
1882
Start Date
2018-12-28
Completion Date
2028-09-30
Last Updated
2026-03-10
Healthy Volunteers
No
Conditions
Interventions
Ofatumumab
subcutaneous injection of 20 mg ofatumumab every 4 weeks
Tetanus toxoid (TT) containing vaccine (Td, Tdap)
0.5mL Vial/Syringe Containing 5 limit of flocculation (LF) tetanus toxoid
13-valent pneumococcal conjugate vaccine (13-PCV)
0.5mL Vial/Syringe
23-valent pneumococcal polysaccharide vaccine (23-PPV)
0.5mL Vial/Syringe
Seasonal Quadrivalent influenza vaccine
Seasonal 2020-2021 0.5mL Vial/Syringe (trivalent may be used where quadrivalent is not available)
Keyhole limpet hemocyanin (KLH) neo-antigen
1mg Vial
Locations (295)
University of Alabama at Birmingham
Birmingham, Alabama, United States
North Central Neurology Associates PC
Cullman, Alabama, United States
Barrow Neurological Clinics at St Josephs Hospital and MC
Phoenix, Arizona, United States
Fullerton Neuro and Headache Ctr
Fullerton, California, United States
University of California Davis
Sacramento, California, United States
CU Anschutz Med Campus
Aurora, Colorado, United States
Mountain Neuro Research Center PC
Basalt, Colorado, United States
Alpine Clinical Research Center
Boulder, Colorado, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
Colorado Neurological Research PC
Denver, Colorado, United States
University of Colorado Health Neurology
Fort Collins, Colorado, United States
Christiana Care Health Services
Newark, Delaware, United States
Jem Research Institute
Atlantis, Florida, United States
Neurology Offices of South Florida PLLC
Delray Beach, Florida, United States
Infinity Clinical Research LLC
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
Aqualane Clinical Research
Naples, Florida, United States
MS and Neuromuscular Center of Excellence
Oldsmar, Florida, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, United States
Emerald Coast Neurology
Pensacola, Florida, United States
Neurostudies Inc
Port Charlotte, Florida, United States
Negroski Neurology
Sarasota, Florida, United States
Roskamp Institute Inc
Sarasota, Florida, United States
AMO Corporation
Tallahassee, Florida, United States
Clinical Research of West Florida Inc
Tampa, 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
Velocity Clinical Research
Savannah, Georgia, United States
Georgia Neurology and Sleep Medicine Assoc
Suwanee, Georgia, United States
Hawaii Pacific Neuroscience LLC
Honolulu, Hawaii, United States
Rush University Medical Center
Chicago, Illinois, United States
Consultants in Neurology
Northbrook, Illinois, United States
Josephson Wallack Munshower Neurology P.C
Indianapolis, Indiana, United States
University of Kansas Hospital
Kansas City, Kansas, United States
College Park Family Care Center
Overland Park, Kansas, United States
Neuro Medical Clinic of Cenla LLC
Alexandria, Louisiana, United States
The Neuromedical Center
Baton Rouge, Louisiana, United States
Dragonfly Research LLC
Wellesley Hills, Massachusetts, United States
Wayne State University Multiple Sclerosis Clinic
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Vivo Infusion
Plymouth, Minnesota, United States
Sharlin Health and Neurology
Ozark, Missouri, United States
WA Uni School Of Med
St Louis, Missouri, United States
Mercy Research
St Louis, Missouri, United States
Billings Clinic
Billings, Montana, United States
Advanced Neurology Specialists
Great Falls, Montana, United States
Cleveland Clinic Foundation
Las Vegas, Nevada, United States
University of New Mexico
Albuquerque, New Mexico, United States
Ms Ctr Of Northeastern Ny
Latham, New York, United States
Asheville Neurology Specialists PA
Asheville, North Carolina, United States
The Neurological Institute PA
Charlotte, North Carolina, United States
Guilford Neurologic Associate Research
Greensboro, North Carolina, United States
Velocity Clinical Research
Raleigh, North Carolina, United States
PMG Research of Winston Salem
Winston-Salem, North Carolina, United States
Neurology and Neuroscience Assos
Akron, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio Health Research Institute
Columbus, Ohio, United States
Columbus Neuroscience
Westerville, Ohio, United States
Multiple Sclerosis Center of Excellence of OMRF
Oklahoma City, Oklahoma, United States
Providence Neurological Services West
Portland, Oregon, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Abington Neurological Associates Ltd
Willow Grove, Pennsylvania, United States
Premier Neurology
Greenville, South Carolina, United States
BG Neurology
Spartanburg, South Carolina, United States
Upstate Clinical Trials LLC
Spartanburg, South Carolina, United States
Wesley Neurology Clinic
Cordova, Tennessee, United States
Tri State Mountain Neurology
Johnson, Tennessee, United States
University of Tennessee Medical Ctr
Knoxville, Tennessee, United States
Sibyl Wray MD Neurology PC
Knoxville, Tennessee, United States
Med Research Inc
El Paso, Texas, United States
Neurology and Sleep Center
Lubbock, Texas, United States
Central TX Neuro Consultants P A
Round Rock, Texas, United States
Lonestar Neurology of San Antonio
San Antonio, Texas, United States
Texas Institute for Neurological Disorders
Sherman, Texas, United States
Rocky Mountain MS Clinic
Salt Lake City, Utah, United States
The University of Utah
Salt Lake City, Utah, United States
Sentara Neuroscience Institute
Virginia Beach, Virginia, United States
Evergreen Health Multiple Sclerosis Center
Kirkland, Washington, United States
MultiCare Research Institute for Research and Innovation
Tacoma, Washington, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
University of Wisconsin Madison
Madison, Wisconsin, United States
Ascension St Francis Center
Milwaukee, Wisconsin, United States
St Luke s Medical Center Aurora
Milwaukee, Wisconsin, United States
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Rosario, Santa Fe Province, Argentina
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San Miguel de Tucumán, Argentina
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New Lambton Heights, New South Wales, Australia
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Liverpool, Australia
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Osijek, Croatia
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Zagreb, Croatia
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Brno, Czechia
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Mangalore, Karnataka, India
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Kochi, Kerala, India
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Mumbai, Maharashtra, India
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Pune, Maharashtra, India
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New Delhi, National Capital Territory of Delhi, India
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Chandigarh, Punjab, India
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Howrah, West Bengal, India
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Ashkelon, Israel
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Haifa, Israel
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Sefad, Israel
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Tel Aviv, Israel
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Tōon, Ehime, Japan
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Sapporo, Hokkaido, Japan
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Morioka, Iwate, Japan
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Sendai, Miyagi, Japan
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Sendai, Miyagi, Japan
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Kawagoe, Saitama, Japan
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Kodaira, Tokyo, Japan
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Shinjuku-ku, Tokyo, Japan
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Chiba, Japan
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Niigata, Japan
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Osaka, Japan
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Riga, LV, Latvia
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Riga, Latvia
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Kaunas, LTU, Lithuania
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Vilnius, Lithuania
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Mexico City, Mexico City, Mexico
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Chihuahua City, Mexico
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Sittard-Geleen, Limburg, Netherlands
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Amsterdam, North Holland, Netherlands
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Rotterdam, South Holland, Netherlands
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Drammen, Norway
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Lima Cercado, Lima region, Peru
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San Isidro, Lima region, Peru
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Lima, Peru
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Bydgoszcz, Woj Kujawsko Pomorskie, Poland
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Gdansk, Poland
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Glogow Wielkopolski, Poland
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Katowice, Poland
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Kielce, Poland
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Lodz, Poland
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Poznan, Poland
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Rzeszów, Poland
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Warsaw, Poland
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Zabrze, Poland
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Braga, Portugal
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Coimbra, Portugal
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Lisbon, Portugal
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Lisbon, Portugal
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Loures, Portugal
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Matosinhos Municipality, Portugal
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Porto, Portugal
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Santa Maria da Feira, Portugal
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Kazan', Russia
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Kemerovo, Russia
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Krasnoyarsk, Russia
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Moscow, Russia
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Moscow, Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Nizhny Novgorod, Russia
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Novosibirsk, Russia
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Novosibirsk, Russia
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Saint Petersburg, Russia
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Saint Petersburg, Russia
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Saransk, Russia
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Sestroretsk, Russia
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Tyumen, Russia
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Yekaterinburg, Russia
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Banská Bystrica, Slovakia
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Bratislava, Slovakia
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Bratislava, Slovakia
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Bratislava, Slovakia
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Martin, Slovakia
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Nitra, Slovakia
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Trnava, Slovakia
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Pretoria, South Africa
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Rosebank, South Africa
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Cadiz, Andalusia, Spain
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L'Hospitalet de Llobregat, Barcelona, Spain
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Barcelona, Catalonia, Spain
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Donostia / San Sebastian, Gipuzkoa, Spain
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Salt, Girona, Spain
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Majadahonda, Madrid, Spain
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Pozuelo de Alarcón, Madrid, Spain
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El Palmar, Murcia, Spain
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Castilleja de la Cuesta, Sevilla, Spain
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Barakaldo, Vizcaya, Spain
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Barcelona, Spain
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Madrid, Spain
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Málaga, Spain
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Seville, Spain
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Valencia, Spain
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Gothenburg, Sweden
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Stockholm, Sweden
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Basel, Switzerland
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Lugano, Switzerland
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Tainan, Taiwan
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Khon Kaen, THA, Thailand
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Samsun, Atakum, Turkey (Türkiye)
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Istanbul, Bakirkoy, Turkey (Türkiye)
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Izmir, Balcova, Turkey (Türkiye)
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Istanbul, Fatih, Turkey (Türkiye)
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Izmir, Karsiyaka, Turkey (Türkiye)
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Trabzon, Ortahisar, Turkey (Türkiye)
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Istanbul, Sancaktepe, Turkey (Türkiye)
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Istanbul, Sultangazi, Turkey (Türkiye)
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Mersin, Yenisehir, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Kocaeli, Turkey (Türkiye)
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Luton, Beds, United Kingdom
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Glasgow, Scotland, United Kingdom
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Sheffield, South Yorkshire, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Oxford, United Kingdom