Last Update: Nov 20, 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).

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.

Relapsing Multiple Sclerosis
Phase3
Recruiting
2060
Dec 28, 2018
Sep 30, 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

Josephson Wallack Munshower Neurology P.C

Recruiting

Indianapolis,Indiana,46256,United States

Craig Edward Herrman

Henry Ford Hospital

Recruiting

Detroit,Michigan,48202 2689,United States

Mirela Cerghet

Lonestar Neurology of San Antonio

Recruiting

San Antonio,Texas,78258,United States

Ann Bass
Virginia Vazquez

Jem Research Institute

Recruiting

Atlantis,Florida,33462-6608,United States

Mark Allen Goldstein

Neuro Medical Clinic of Cenla LLC

Recruiting

Alexandria,Louisiana,71301,United States

Mary Rabalais
Ariel Antezana-Antezana

University of Tennessee Medical Center

Recruiting

Knoxville,Tennessee,37920,United States

Patricia Pryor
Randall Trudell

Billings Clinic

Recruiting

Billings,Montana,59101,United States

Sara Qureshi
Sarah Hall

The Neuromedical Center

Recruiting

Baton Rouge,Louisiana,70810,United States

Danielle Bryant
Jon Olson

University of Kansas Hospital

Recruiting

Kansas City,Kansas,66160,United States

Lisa Schmidt
Sharon Lynch

Texas Institute for Neurological Disorders

Recruiting

Sherman,Texas,75092,United States

Bharathy E. Sundaram

Neurology Offices of South Florida PLLC

Recruiting

Delray Beach,Florida,33445,United States

Brian Costell

University of Alabama at Birmingham

Recruiting

Birmingham,Alabama,35233-0271,United States

Jennifer Mahaffey
Khurram Bashir

Hope Neurology

Recruiting

Knoxville,Tennessee,37922,United States

Sarah Waters
Sibyl Wray

Cleveland Clinic Foundation

Recruiting

Cleveland,Ohio,44195,United States

Jeffrey Cohen
Tammy Skaramagas

Wayne State University Multiple Sclerosis Clinic

Recruiting

Detroit,Michigan,48201,United States

Carla Santiago
Jacob Rube

College Park Family Care Center

Recruiting

Overland Park,Kansas,66210,United States

Jeffrey Kaplan
Kristen Giese

Rush University Medical Center

Recruiting

Chicago,Illinois,60612,United States

Christian Holt
Thomas Shoemaker

Evergreen Health Multiple Sclerosis Center

Recruiting

Kirkland,Washington,98034,United States

Amenah Al Khafaji
Theodore Brown

North Central Neurology Associates PC

Recruiting

Cullman,Alabama,35058,United States

Christopher LaGanke
Magan Bender

Neurology and Sleep Center

Recruiting

Lubbock,Texas,79410,United States

Bhupesh Dihenia
Zenaida Hernandez

Wesley Neurology Clinic

Recruiting

Cordova,Tennessee,38018,United States

Kendrick K Henderson

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