Study Description
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).
Interventions
13-valent pneumococcal conjugate vaccine (13-PCV)
23-valent pneumococcal polysaccharide vaccine (23-PPV)
Keyhole limpet hemocyanin (KLH) neo-antigen
Ofatumumab
Seasonal Quadrivalent influenza vaccine
Tetanus toxoid (TT) containing vaccine (Td, Tdap)
Eligibility Criteria
Inclusion Criteria:
Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
Written informed consent
Exclusion Criteria:
Emergence of any clinically significant condition/disease during the previous ofatumumab study in which study participation might result in safety risk for the subject
Subjects with active systemic bacterial, viral or fingal infections, or chronic infection (e.g. AIDS)
Subjects taking medications prohibited by the protocol
Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply
Vaccination sub-study:
Inclusion criteria
Informed consent
Actively enrolled in the COMB157G2399 Study
12 weeks of continuous treatment within the COMB157G2399 Study
prior vaccination history as per protocol-defined
Exclusion criteria
known hypersensitivity or history of systemic allergic, neurologic or other reactions to vaccines
allergies to egg or shellfish
any safety findings including low IgG/IgM requiring ofatumumab interruption within 12 weeks prior to vaccination sub-study start
any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks of the first vaccination sub-study visit
Other protocol-defined inclusion/exclusion criteria may apply
Study Location
Novartis Investigative Site
Recruiting
Sofia,1413,Bulgaria
Novartis Investigative Site
Recruiting
Budapest,1138,Hungary
Novartis Investigative Site
Recruiting
Pecs,7623,Hungary
Novartis Investigative Site
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Budapest,1204,Hungary
Novartis Investigative Site
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Budapest,HUN,1135,Hungary
Novartis Investigative Site
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Bydgoszcz,Woj Kujawsko-pomorskie,85-796,Poland
Novartis Investigative Site
Recruiting
Trabzon,61080,Turkey
Novartis Investigative Site
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Izmir,35040,Turkey
Novartis Investigative Site
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Izmir,35575,Turkey
Novartis Investigative Site
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Samsun,55139,Turkey
Novartis Investigative Site
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Sancaktepe,Istanbul,34785,Turkey
Novartis Investigative Site
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Istanbul,TUR,34098,Turkey
Jem Research Institute
Recruiting
Atlantis,(+1 561 968 2933 302) -- Mark Goldstein,33462-6608 - Florida,United States
Barrow Neurological Clinics at St Josephs Hospital and MC
Recruiting
Phoenix,Stacey Lent (602-406-6795) email: [email protected] -- Aimee Borazanci,85013 - Arizona,United States
Neurostudies Inc
Recruiting
Port Charlotte,Patricia Trumble (941-764-0800) email: [email protected] -- Liliana Montoya,33952 - Florida,United States
University of Alabama at Birmingham
Recruiting
Birmingham,Jennifer Mahaffey (205-502-9967) email: [email protected] -- Khurram Bashir,35233-0271 - Alabama,United States
Georgia Neurology and Sleep Medicine Assoc
Recruiting
Suwanee,(770-814-9455) -- David Lesch,30024 - Georgia,United States
Alpine Clinical Research Center
Recruiting
Boulder,(303-443-7229) -- Paul Brownstone,80301 - Colorado,United States
Neuro Medical Clinic of Cenla LLC COMB157G2301
Recruiting
Alexandria,Banojir Sultana (318-443-0490) email: [email protected] -- Ariel Antezana-Antezana,71301 - Louisiana,United States
Rush University Medical Center
Recruiting
Chicago,Christian Holt (312-942-8011) email: [email protected] -- Thomas Shoemaker,60612 - Illinois,United States
College Park Family Care Center
Recruiting
Overland Park,Amy L Dix (913-469-9887) email: [email protected] -- Jeffrey Kaplan,66210 - Kansas,United States
Velocity Clinical Research
Recruiting
Raleigh,Sarah Mounib (984-251-1336) email: [email protected] -- John Scagnelli,27607 - North Carolina,United States
Josephson Wallack Munshower Neurology P.C
Recruiting
Indianapolis,(+1 (317) 537-6060) -- Craig Edward Herrman,46256 - Indiana,United States
Billings Clinic
Recruiting
Billings,Sarah Hall (406-435-7459) email: [email protected] -- Sara Qureshi,59101 - Montana,United States
North Cntrl Neurology Associates PC
Recruiting
Cullman,Magan Bender (256-739-1210) email: [email protected] -- Christopher LaGanke,35058 - Alabama,United States
University of California Davis
Recruiting
Sacramento,Molly Lindsay (916-734-8033) email: [email protected] -- Michelle Apperson,95817 - California,United States
Hawaii Pacific Neuroscience LLC
Recruiting
Honolulu,Samuel Kim (808-261-4476) email: [email protected] -- Kore Liow,96817 - Hawaii,United States
Ohio Health Research Institute
Recruiting
Columbus,Katy Groezinger (614-566-1262) email: [email protected] -- Jacqueline Nicholas,43214 - Ohio,United States
Neurology and Sleep Center
Recruiting
Lubbock,Zenaida Hernandez (806-722-3500) email: [email protected] -- Bhupesh Dihenia,79410 - Texas,United States
Sentara Neuroscience Institute
Recruiting
Virginia Beach,(757-507-0642) -- Michelle B Betz,23456 - Virginia,United States
AMO Corporation
Recruiting
Tallahassee,Jeff Devore (850-656-6377) email: [email protected] -- Ricardo Ayala,32312 - Florida,United States
Colorado Springs Neurological Associates .
Recruiting
Colorado Springs,Devon Glaze (719-389-1129) email: [email protected] -- Kimberly Wagner,80907 - Colorado,United States
Velocity Clinical Research
Recruiting
Savannah,(912-790-4837) -- J Michael Hemphill,31406 - Georgia,United States
Med Research Inc
Recruiting
El Paso,Diego Vasallo (+1 915 307 4669) email: [email protected] -- Javier Alejandro Vasallo,79935 - Texas,United States
University of Kansas Medical Center .
Recruiting
Kansas City,Michael Molloy (913-588-0614) email: [email protected] -- Sharon Lynch,66160-7330 - Kansas,United States
Bradenton Research Center inc
Recruiting
Bradenton,Gloria Carlbert (941-746-3115) email: [email protected] -- Eric Folkens,34205 - Florida,United States
Henry Ford Hospital Main Centre
Recruiting
Detroit,(313-556-8186) -- Mirela Cerghet,48202 2689 - Michigan,United States
Premier Neurology
Recruiting
Greenville,Leann Putman (+1 864 655 4005) email: [email protected] -- Mary Denise Hughes,29650 - South Carolina,United States
Neurology Associates of Ormond Beach
Recruiting
Ormond Beach,Tim Sneed (386-676-6340) email: [email protected] -- James Scott,32174 - Florida,United States
Texas Institute for Neurological Disorders
Recruiting
Sherman,(+1 903 893 5141#4334) -- Bharathy E. Sundaram,75092 - Texas,United States
Aqualane Clinical Research
Recruiting
Naples,Alexandria Smith (239-434-0332) email: [email protected] -- Matthew J Baker,34102 - Florida,United States
Washington Uni School of Med
Recruiting
Saint Louis,Robert Naismith,63110 - Missouri,United States
CU Anschutz Med Campus
Recruiting
Aurora,Sushil Rijal (303-724-0183) email: [email protected] -- Enrique Alvarez,80045 - Colorado,United States
Mercy Research
Recruiting
Saint Louis,Samantha Mulqueeny (636-893-1258) email: [email protected] -- William Logan,63141 - Missouri,United States
University of Miami Miller School of Medicine
Recruiting
Miami,Bettina Daneri (305-243-7424) email: [email protected] -- Silvia R Delgado,33136 - Florida,United States
Christiana Care Health Services
Recruiting
Newark,Theresa Whitehead Izwylde (+1 302 623 3844) email: [email protected] -- Jason M Silversteen,19713 - Delaware,United States
Premiere Research Institute
Recruiting
West Palm Beach,(561-845-0500) -- Paul K. Winner,33407 - Florida,United States
Homestead Associates in Research Inc
Recruiting
Miami,Arianna Perez (305-246-0873) email: [email protected] -- Angel Carrasco,33032 - Florida,United States
Neurology Associates, PA
Recruiting
Maitland,Nicole Perovic (+1 407 647 5996) email: [email protected] -- William David Honeycutt,32751 - Florida,United States
The Neurological Institute PA
Recruiting
Charlotte,Jada Russell (+1 704 449 6064) email: [email protected] -- T Hemanth Hemanth Rao,28204 - North Carolina,United States
Ascension St Francis Center
Recruiting
Milwaukee,Sarah Duhr (414-769-4040) email: [email protected] -- Bhupendra Khatri,53215 - Wisconsin,United States
Wayne Stat Uni Multi Sclerosis Clnc
Recruiting
Detroit,Rachel Darling (313-745-4220) email: [email protected] -- Evanthia Bernitsas,48201 - Michigan,United States
Emerald Coast Neurology
Recruiting
Pensacola,Aysha McGrath (850-438-1136) email: [email protected] -- David Bear,32514 - Florida,United States
MS and Neuromuscular Center of Excellence
Recruiting
Oldsmar,Jodi Mummert (727-631-0779) email: [email protected] -- Jean-Raphael Schneider,34677 - Florida,United States
University of South Florida
Recruiting
Tampa,Janaye Brown (813-974-6378) email: [email protected] -- Derrick Robertson,33612 - Florida,United States
Cleveland Clinic Foundation
Recruiting
Las Vegas,(702-483-6003) -- Carrie M Hersh,89106 - Nevada,United States
Providence Neurological Services West
Recruiting
Portland,Lee Tillman (503-216-1023) email: [email protected] -- Stanley Cohan,97225 - Oregon,United States
Hope Neurology
Recruiting
Knoxville,Sarah Waters (865-218-6222) email: [email protected] -- Sibyl Wray,37922 - Tennessee,United States
Neurology Center of San Antonio P.A.
Recruiting
San Antonio,Sofia Sacco (+1 210 490 0016 #23) email: [email protected] -- Ann Bass,78258 - Texas,United States
The Neuromedical Center
Recruiting
Baton Rouge,Kandice Lemoine (608-848-8900) email: [email protected] -- Jon Olson,70810 - Louisiana,United States
Asheville Neurology Specialists PA
Recruiting
Asheville,(+1 828 210 9311) -- Robert Fairborn Armstrong,28806 - North Carolina,United States
Wesley Neurology Clinic
Recruiting
Cordova,Rhonda Wallace (901-866-9252) email: [email protected] -- Kendrick K Henderson,38018 - Tennessee,United States
Evergreen Health Multiple Sclerosis Center
Recruiting
Kirkland,Amenah Al Khafaji (425-899-0555) email: [email protected] -- Theodore Brown,98034 - Washington,United States
Multiple Sclerosis Center of Excellence of OMRF
Recruiting
Oklahoma City,Kellie Kraus (405-271-6242) email: [email protected] -- Gabriel Pardo,73104 - Oklahoma,United States
University of Tennessee Medical Center COMB157G2301
Recruiting
Knoxville,Sandy Flamini (865-305-9100) email: [email protected] -- Randall Trudell,37920 - Tennessee,United States
Cleveland Clinic Foundation .
Recruiting
Cleveland,Sadie Coates (216-445-2572) email: [email protected] -- Jeffrey Cohen,44195 - Ohio,United States
Infinity Clinical Research LLC
Recruiting
Hollywood,Rebecca Nembhard (954-475-8171) email: [email protected] -- Barry Cutler,33024 - Florida,United States
Axiom Clinical Research of Florida
Recruiting
Tampa,Fnu Madhuri (813-353-9613) email: [email protected] -- Mark Cascione,33609 - Florida,United States
Neurology Offices of South Florida PLLC CBAF312A2304
Recruiting
Delray Beach,(561-482-1027) -- Brian Costell,33445 - Florida,United States
Thomas Jefferson University Hospital
Recruiting
Philadelphia,Joanna Wisniewski (215-955-5335) email: [email protected] -- Thomas Leist,19107-5098 - Pennsylvania,United States
Fullerton Neuro and Headache Ctr
Recruiting
Fullerton,Vanessa Mariscal (714-738-0800) email: [email protected] -- Jack H Florin,92835 - California,United States
Abington Neurological Associates Ltd
Recruiting
Willow Grove,(215-957-9250) -- David Weisman,19090 - Pennsylvania,United States
Negroski Neurology
Recruiting
Sarasota,(941-487-2160) -- Donald Negroski,34233 - Florida,United States
Roskamp Institute, Inc.
Recruiting
Sarasota,(941-256-8018) -- Sanjay Yathiraj,34243 - Florida,United States
Clinical Research Of West FL Inc
Recruiting
Tampa,Eileenys Hernandez (813-870-1292) email: [email protected] -- Lon D. Lynn,33603 - Florida,United States
University of Wisconsin Madison
Recruiting
Madison,Lucy Ptak (608-265-6544) email: [email protected] -- Christopher Luzzio,53792 - Wisconsin,United States
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.