In short
This article discusses clinical trials investigating the use of ofatumumab, a medication for treating relapsing multiple sclerosis (RMS). The trials aim to evaluate the long-term safety, tolerability, and effectiveness of ofatumumab in patients with RMS. These studies are important for understanding how the drug performs over extended periods and its potential benefits for managing this chronic neurological condition.
At a glance
- Study Type
- Open-label, single arm, multi-center extension study
- Primary Objective
- Evaluate long-term safety and tolerability of ofatumumab
- Secondary Objectives
- Describe long-term efficacy, compare outcomes, explore health outcomes
- Inclusion Criteria
- Previous participation in Novartis MS study with ofatumumab, adults with RMS
- Exclusion Criteria
- Premature discontinuation, active infections, PML
- Primary Endpoints
- Adverse events, laboratory results, ECG, suicide risk assessment
- Secondary Endpoints
- Relapse rate, disability progression, MRI measures, brain volume changes
- Duration
- Through Week 240 (End of Study)
What is B/PHUKET/3073/2013-LIKE VIRUS?
B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE) is a specific strain of influenza virus used in the production of influenza vaccines. This virus strain is one of the components in a vaccine called Flucelvax Tetra, which is designed to protect against influenza, commonly known as the flu.
Vaccine Composition
Flucelvax Tetra is a quadrivalent influenza vaccine, which means it contains four different strains of influenza virus to provide broad protection against various flu types. The vaccine includes the following components:
- B/PHUKET/3073/2013-LIKE VIRUS (B/SINGAPORE/INFTT-16-0610/2016, WILD TYPE)
- B/AUSTRIA/1359417/2021-LIKE STRAIN (B/SINGAPORE/WUH4618/2021)
- A/DARWIN/6/2021(H3N2)-LIKE STRAIN (A/DARWIN/11/2021, WILD TYPE)
- A/WISCONSIN/67/2022 (H1N1)PDM09-LIKE STRAIN (A/GEORGIA/12/2022 CVR-167)
Each of these components represents a different strain of influenza virus, helping to protect against multiple types of flu that may circulate in a given season.
Medical Use
Flucelvax Tetra, which contains the B/PHUKET/3073/2013-LIKE VIRUS, is used for the prevention of influenza. Influenza is a contagious respiratory illness that can cause mild to severe illness, and in some cases, can lead to hospitalization or even death, especially in high-risk groups such as young children, older adults, and people with certain health conditions.
The vaccine works by stimulating the body's immune system to produce antibodies against the influenza virus strains contained in the vaccine. This helps the body recognize and fight off these specific flu viruses if exposed to them later.
Administration
Flucelvax Tetra is administered as an intramuscular injection. This means the vaccine is injected directly into a muscle, typically in the upper arm for adults and older children, or the thigh for infants.
The vaccine is provided as a suspension for injection in a pre-filled syringe. The typical dose is 0.5 ml, which contains all four virus strains, including the B/PHUKET/3073/2013-LIKE VIRUS.
Synonyms
The B/PHUKET/3073/2013-LIKE VIRUS is also known by the following synonym:
- B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type)
This alternative name may be used in scientific literature or other vaccine descriptions, but they refer to the same virus strain used in the Flucelvax Tetra vaccine.