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Clinical Trials in Spain / NCT03650114
Active, not recruiting Phase 3

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

NCT03650114 · tracked via the Priya Life Science Spain 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)

Ofatumumab →Tetanus 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
No
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)

FacilityCityRegionStatus
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.

More Novartis Pharmaceuticals trials in Spain

Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2) Active, not recruiting
Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study Recruiting
Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies Active, not recruiting
A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy Recruiting
A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC Recruiting

Other trials for the same condition

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-2) Active, not recruiting
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) Active, not recruiting
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis. Recruiting
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-1) Active, not recruiting
A Study of Obexelimab in Patients With Relapsing Multiple Sclerosis (MoonStone) 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 Spain