NCT03650114

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

An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,882 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	Ofatumumab	subcutaneous injection of 20 mg ofatumumab every 4 weeks
BIOLOGICAL	Tetanus toxoid (TT) containing vaccine (Td, Tdap)	0.5mL Vial/Syringe Containing 5 limit of flocculation (LF) tetanus toxoid
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	Seasonal Quadrivalent influenza vaccine	Seasonal 2020-2021 0.5mL Vial/Syringe (trivalent may be used where quadrivalent is not available)
BIOLOGICAL	Keyhole limpet hemocyanin (KLH) neo-antigen	1mg Vial

Timeline

• Start date: 2018-12-28
• Primary completion: 2027-12-30
• Completion: 2028-09-30
• First posted: 2018-08-28
• Last updated: 2026-03-10

Locations

295 sites across 37 countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Israel, Japan, Latvia, Lithuania, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study