Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

NCT03650114 · tracked via the Priya Life Science UK tracker

Sponsor

Novartis Pharmaceuticals

Phase

Phase 3

Started

2018-12-28

Last updated

2026-05-27

Condition(s) studied

Relapsing Multiple Sclerosis

Investigational drug(s) / intervention(s)

OfatumumabTetanus toxoid (TT) containing vaccine (Td, Tdap)13-valent pneumococcal conjugate vaccine (13-PCV)23-valent pneumococcal polysaccharide vaccine (23-PPV)Seasonal Quadrivalent influenza vaccineKeyhole limpet hemocyanin (KLH) neo-antigen

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

Study 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

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

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

Primary outcome measure(s)

Number of patients that experience an adverse event or abnormal laboratory, vital and/or ECG results and positive suicidiality outcomes — Up to 8 years

Trial sites (295)

Facility	City	Region
University of Alabama at Birmingham	Birmingham	Alabama
North Central Neurology Associates PC	Cullman	Alabama
Barrow Neurological Clinics at St Josephs Hospital and MC	Phoenix	Arizona
Fullerton Neuro and Headache Ctr	Fullerton	California
University of California Davis	Sacramento	California
CU Anschutz Med Campus	Aurora	Colorado
Mountain Neuro Research Center PC	Basalt	Colorado
Alpine Clinical Research Center	Boulder	Colorado
Colorado Springs Neurological Associates	Colorado Springs	Colorado
Colorado Neurological Research PC	Denver	Colorado
University of Colorado Health Neurology	Fort Collins	Colorado
Christiana Care Health Services	Newark	Delaware
Jem Research Institute	Atlantis	Florida
Neurology Offices of South Florida PLLC	Delray Beach	Florida
Infinity Clinical Research LLC	Hollywood	Florida
Homestead Assoc In Research Inc	Homestead	Florida
Neurology Associates PA	Maitland	Florida
UM Department Of Neurology	Miami	Florida
Aqualane Clinical Research	Naples	Florida
MS and Neuromuscular Center of Excellence	Oldsmar	Florida
Neurology Associates of Ormond Beach	Ormond Beach	Florida
Emerald Coast Neurology	Pensacola	Florida
Neurostudies Inc	Port Charlotte	Florida
Negroski Neurology	Sarasota	Florida
Roskamp Institute Inc	Sarasota	Florida
AMO Corporation	Tallahassee	Florida
Clinical Research of West Florida Inc	Tampa	Florida
Axiom Clinical Research of Florida	Tampa	Florida
University Of South Florida	Tampa	Florida
Premiere Research Institute	West Palm Beach	Florida
Velocity Clinical Research	Savannah	Georgia
Georgia Neurology and Sleep Medicine Assoc	Suwanee	Georgia
Hawaii Pacific Neuroscience LLC	Honolulu	Hawaii
Rush University Medical Center	Chicago	Illinois
Consultants in Neurology	Northbrook	Illinois
Josephson Wallack Munshower Neurology PC	Indianapolis	Indiana
University of Kansas Hospital	Kansas City	Kansas
College Park Family Care Center	Overland Park	Kansas
Neuro Medical Clinic of Cenla LLC	Alexandria	Louisiana
The Neuromedical Center	Baton Rouge	Louisiana

+ 255 more sites — see the full list on the official registry below.

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Other trials for the same condition

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-1) Active, not recruiting

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-2) Active, not recruiting

Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis. Recruiting

A Study of Obexelimab in Patients With Relapsing Multiple Sclerosis (MoonStone) Active, not recruiting

Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03650114 on ClinicalTrials.gov ↗ ← All trials in the UK