An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis
Who is this study for? Patients with Multiple Sclerosis
What treatments are being studied? Ofatumumab+Tetanus Toxoid+13-Valent Pneumococcal+23-Valent Pneumococcal+Seasonal Quadrivalent+Keyhole Limpet Hemocyanin
Status: Active_not_recruiting
Location: See all (285) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
• Written informed consent
• Informed consent
• Actively enrolled in the COMB157G2399 Study
• 12 weeks of continuous treatment within the COMB157G2399 Study
• prior vaccination history as per protocol-defined
Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
North Central Neurology Associates PC
Cullman
Arizona
Barrow Neurological Clinics at St Josephs Hospital and MC
Phoenix
California
Fullerton Neuro and Headache Ctr
Fullerton
University of California Davis
Sacramento
Colorado
CU Anschutz Med Campus
Aurora
Mountain Neuro Research Center PC
Basalt
Alpine Clinical Research Center
Boulder
Colorado Springs Neurological Associates
Colorado Springs
Colorado Neurological Research PC
Denver
University of Colorado Health Neurology
Fort Collins
Delaware
Christiana Care Health Services
Newark
Florida
Jem Research Institute
Atlantis
Neurology Offices of South Florida PLLC
Delray Beach
Infinity Clinical Research LLC
Hollywood
Homestead Assoc In Research Inc
Homestead
Neurology Associates PA
Maitland
UM Department Of Neurology
Miami
Aqualane Clinical Research
Naples
MS and Neuromuscular Center of Excellence
Oldsmar
Neurology Associates of Ormond Beach
Ormond Beach
Emerald Coast Neurology
Pensacola
Neurostudies Inc
Port Charlotte
Negroski Neurology
Sarasota
Roskamp Institute Inc
Sarasota
AMO Corporation
Tallahassee
Axiom Clinical Research of Florida
Tampa
Clinical Research of West Florida Inc
Tampa
University Of South Florida
Tampa
Premiere Research Institute
West Palm Beach
Georgia
Velocity Clinical Research
Savannah
Georgia Neurology and Sleep Medicine Assoc
Suwanee
Hawaii
Hawaii Pacific Neuroscience LLC
Honolulu
Illinois
Rush University Medical Center
Chicago
Consultants in Neurology
Northbrook
Indiana
Josephson Wallack Munshower Neurology P.C
Indianapolis
Kansas
University of Kansas Hospital
Kansas City
College Park Family Care Center
Overland Park
Louisiana
Neuro Medical Clinic of Cenla LLC
Alexandria
The Neuromedical Center
Baton Rouge
Massachusetts
Dana Farber Cancer Institute
Boston
Dragonfly Research LLC
Wellesley Hills
Michigan
Henry Ford Hospital
Detroit
Wayne State University Multiple Sclerosis Clinic
Detroit
Missouri
Sharlin Health and Neurology
Ozark
Mercy Research
St Louis
WA Uni School Of Med
St Louis
Montana
Billings Clinic
Billings
Advanced Neurology Specialists
Great Falls
North Carolina
Asheville Neurology Specialists PA
Asheville
The Neurological Institute PA
Charlotte
Guilford Neurologic Associate Research
Greensboro
Velocity Clinical Research
Raleigh
PMG Research of Winston Salem
Winston-salem
New Mexico
University of New Mexico
Albuquerque
Nevada
Cleveland Clinic Foundation
Las Vegas
New York
Ms Ctr Of Northeastern Ny
Latham
Ohio
Neurology and Neuroscience Assos
Akron
Cleveland Clinic Foundation
Cleveland
Ohio Health Research Institute
Columbus
Columbus Neuroscience
Westerville
Oklahoma
Multiple Sclerosis Center of Excellence of OMRF
Oklahoma City
Oregon
Providence Neurological Services West
Portland
Pennsylvania
Thomas Jefferson University Hospital
Philadelphia
Abington Neurological Associates Ltd
Willow Grove
South Carolina
Premier Neurology
Greenville
BG Neurology
Spartanburg
Upstate Clinical Trials LLC
Spartanburg
Tennessee
Wesley Neurology Clinic
Cordova
Tri State Mountain Neurology
Johnson
Sibyl Wray MD Neurology PC
Knoxville
University of Tennessee Medical Ctr
Knoxville
Texas
Med Research Inc
El Paso
Neurology and Sleep Center
Lubbock
Central TX Neuro Consultants P A
Round Rock
Lonestar Neurology of San Antonio
San Antonio
Texas Institute for Neurological Disorders
Sherman
Utah
Rocky Mountain MS Clinic
Salt Lake City
The University of Utah
Salt Lake City
Virginia
Sentara Neuroscience Institute
Virginia Beach
Washington
Evergreen Health Multiple Sclerosis Center
Kirkland
MultiCare Research Institute for Research and Innovation
Tacoma
Wisconsin
Aurora BayCare Medical Center
Green Bay
University of Wisconsin Madison
Madison
Ascension St Francis Center
Milwaukee
St Luke s Medical Center Aurora
Milwaukee
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Luton
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Oxford
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Time Frame
Start Date: 2018-12-28
Completion Date: 2028-09-30
Participants
Target number of participants: 1882
Treatments
Experimental: Ofatumumab
Subcutaneous injection
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals