Last Update: May 22, 2024
An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis
ClinicalTrials.gov Identifier:
Novartis Reference Number:COMB157G2399
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

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).

Relapsing Multiple Sclerosis
Phase3
Recruiting
2060
Dec 28, 2018
Sep 07, 2028
All
18 Years - 100 Years (Adult, Older Adult)

Interventions

Biological

13-valent pneumococcal conjugate vaccine (13-PCV)

0.5mL Vial/Syringe
Biological

23-valent pneumococcal polysaccharide vaccine (23-PPV)

0.5mL Vial/Syringe
Biological

Keyhole limpet hemocyanin (KLH) neo-antigen

1mg Vial
Biological

Ofatumumab

subcutaneous injection of 20 mg ofatumumab every 4 weeks
Biological

Seasonal Quadrivalent influenza vaccine

Seasonal 2020-2021 0.5mL Vial/Syringe (trivalent may be used where quadrivalent is not available)
Biological

Tetanus toxoid (TT) containing vaccine (Td, Tdap)

0.5mL Vial/Syringe Containing 5 limit of flocculation (LF) tetanus toxoid

Eligibility Criteria

Inclusion Criteria:

1. Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc
every 4 weeks

2. 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

1. Informed consent

2. Actively enrolled in the COMB157G2399 Study

3. 12 weeks of continuous treatment within the COMB157G2399 Study

4. 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

Recruiting

Budapest,1204,Hungary

Novartis Investigative Site

Recruiting

Budapest,HUN,1135,Hungary

Novartis Investigative Site

Recruiting

Bydgoszcz,Woj Kujawsko-pomorskie,85-796,Poland

Novartis Investigative Site

Recruiting

Istanbul,TUR,34098,Turkey

Novartis Investigative Site

Recruiting

Trabzon,61080,Turkey

Novartis Investigative Site

Recruiting

Izmir,35040,Turkey

Novartis Investigative Site

Recruiting

Izmir,35575,Turkey

Novartis Investigative Site

Recruiting

Samsun,55139,Turkey

Novartis Investigative Site

Recruiting

Sancaktepe,Istanbul,34785,Turkey

Rush University Medical Center

Recruiting

Chicago,Illinois,60612,United States

Fullerton Neuro and Headache Ctr

Recruiting

Fullerton,California,92835,United States

Velocity Clinical Research

Recruiting

Raleigh,North Carolina,27607,United States

Negroski Neurology

Recruiting

Sarasota,Florida,34233,United States

Clinical Research Of West FL Inc

Recruiting

Tampa,Florida,33603,United States

University of California Davis

Recruiting

Sacramento,California,95817,United States

Jem Research Institute

Recruiting

Atlantis,Florida,33462-6608,United States

Barrow Neurological Clinics at St Josephs Hospital and MC

Recruiting

Phoenix,Arizona,85013,United States

Neurostudies Inc

Recruiting

Port Charlotte,Florida,33952,United States

Sentara Neuroscience Institute

Recruiting

Virginia Beach,Virginia,23456,United States

Georgia Neurology and Sleep Medicine Assoc

Recruiting

Suwanee,Georgia,30024,United States

Alpine Clinical Research Center

Recruiting

Boulder,Colorado,80301,United States

Velocity Clinical Research

Recruiting

Savannah,Georgia,31406,United States

Neuro Medical Clinic of Cenla LLC COMB157G2301

Recruiting

Alexandria,Louisiana,71301,United States

College Park Family Care Center

Recruiting

Overland Park,Kansas,66210,United States

Josephson Wallack Munshower Neurology P.C

Recruiting

Indianapolis,Indiana,46256,United States

University of Kansas Medical Center .

Recruiting

Kansas City,Kansas,66160-7330,United States

Billings Clinic

Recruiting

Billings,Montana,59101,United States

North Cntrl Neurology Associates PC

Recruiting

Cullman,Alabama,35058,United States

Texas Institute for Neurological Disorders

Recruiting

Sherman,Texas,75092,United States

Hawaii Pacific Neuroscience LLC

Recruiting

Honolulu,Hawaii,96817,United States

Ohio Health Research Institute

Recruiting

Columbus,Ohio,43214,United States

Neurology and Sleep Center

Recruiting

Lubbock,Texas,79410,United States

AMO Corporation

Recruiting

Tallahassee,Florida,32312,United States

WA Uni School Of Med

Recruiting

Saint Louis,Missouri,63110,United States

Colorado Springs Neurological Associates .

Recruiting

Colorado Springs,Colorado,80907,United States

University of Miami Miller School of Medicine

Recruiting

Miami,Florida,33136,United States

Med Research Inc

Recruiting

El Paso,Texas,79935,United States

Bradenton Research Center inc

Recruiting

Bradenton,Florida,34205,United States

The Neurological Institute PA

Recruiting

Charlotte,North Carolina,28204,United States

Henry Ford Hospital Main Centre

Recruiting

Detroit,Michigan,48202 2689,United States

Premier Neurology

Recruiting

Greenville,South Carolina,29650,United States

Wayne Stat Uni Multi Sclerosis Clnc

Recruiting

Detroit,Michigan,48201,United States

Neurology Associates of Ormond Beach

Recruiting

Ormond Beach,Florida,32174,United States

Aqualane Clinical Research

Recruiting

Naples,Florida,34102,United States

CU Anschutz Med Campus

Recruiting

Aurora,Colorado,80045,United States

University Of South Florida

Recruiting

Tampa,Florida,33612,United States

Mercy Research

Recruiting

Saint Louis,Missouri,63141,United States

Christiana Care Health Services

Recruiting

Newark,Delaware,19713,United States

Premiere Research Institute

Recruiting

West Palm Beach,Florida,33407,United States

The Neuromedical Center

Recruiting

Baton Rouge,Louisiana,70810,United States

Homestead Associates in Research Inc

Recruiting

Miami,Florida,33032,United States

Wesley Neurology Clinic

Recruiting

Cordova,Tennessee,38018,United States

Neurology Associates, PA

Recruiting

Maitland,Florida,32751,United States

Ascension St Francis Center

Recruiting

Milwaukee,Wisconsin,53215,United States

Emerald Coast Neurology

Recruiting

Pensacola,Florida,32514,United States

University of Tennessee Medical Center COMB157G2301

Recruiting

Knoxville,Tennessee,37920,United States

MS and Neuromuscular Center of Excellence

Recruiting

Oldsmar,Florida,34677,United States

Cleveland Clinic Foundation

Recruiting

Las Vegas,Nevada,89106,United States

Providence Neurological Services West

Recruiting

Portland,Oregon,97225,United States

Thomas Jefferson University Hospital

Recruiting

Philadelphia,Pennsylvania,19107-5098,United States

Hope Neurology

Recruiting

Knoxville,Tennessee,37922,United States

Neurology Center of San Antonio P.A.

Recruiting

San Antonio,Texas,78258,United States

Asheville Neurology Specialists PA

Recruiting

Asheville,North Carolina,28806,United States

Evergreen Health Multiple Sclerosis Center

Recruiting

Kirkland,Washington,98034,United States

University of Wisconsin Madison

Recruiting

Madison,Wisconsin,53792,United States

Multiple Sclerosis Center of Excellence of OMRF

Recruiting

Oklahoma City,Oklahoma,73104,United States

Cleveland Clinic Foundation .

Recruiting

Cleveland,Ohio,44195,United States

Roskamp Institute, Inc.

Recruiting

Sarasota,Florida,34243,United States

University of Alabama at Birmingham

Recruiting

Birmingham,Alabama,35233-0271,United States

Infinity Clinical Research LLC

Recruiting

Hollywood,Florida,33024,United States

Axiom Clinical Research of Florida

Recruiting

Tampa,Florida,33609,United States

Neurology Offices of South Florida PLLC CBAF312A2304

Recruiting

Delray Beach,Florida,33445,United States

Worldwide Contacts

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Novartis Pharmaceuticals

Novartis Pharmaceuticals