A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis
Total # of Subjects Needed:
Approximately 1800 patients in 40 countries
The main purpose of the study is to find out if patients treated with ofatumumab may
experience fewer MS relapses (also called clinical attacks, exacerbations or flare ups) than
patients treated with Aubagio® (also known as teriflunomide). Teriflunomide is an approved
medication for the treatment of relapsing MS.
MS is a long-term illness where the body’s immune system attacks and damages the protective covering (called myelin) around the nerves in the central nervous system. Damaged myelin results in scar tissue or “sclerosis”. Because this scar tissue does not transfer signals from the
brain as well as normal myelin, nerves stop working properly. Such scars can be seen on a scan called magnetic resonance imaging (MRI).
People with relapsing MS (relapsing-remitting MS or secondary progressive MS with relapses) will have repeated attacks, or “relapses”. During these relapses, your own immune system attacks the nerves in your brain or spinal cord, damaging the myelin covering. This can result
in symptoms including difficulty walking, balance problems, vision problems, and more. Some symptoms may not completely recover after the relapse leading to accumulation of disability over time.
The immune system is made up of many different types of cells that work together to fight infection, among them B cells and lymphocytes, which are types of white blood cells. Both ofatumumab and teriflunomide target cells in the immune system, however, the way they do this differs. Ofatumumab works by temporarily removing the number of B-cells, a type of white blood cell, while teriflunomide works by limiting the increase of a type of white blood cells called lymphocytes. Both types of white blood cells are involved in the process of inflammation that is believed to play a role in damaging the myelin and in some of the symptoms in MS. Bcells produce ‘antibodies’ which fight infection but are also responsible for some of the damage that is done to your nerve cells in multiple sclerosis.
The reason for the use of teriflunomide in this study is to find out if ofatumumab is better than teriflunomide as a treatment of relapsing MS. Because we do not know which medicine is best, we need to make comparisons. This research study will try to answer to the following questions:
– How well does ofatumumab work in reducing relapses, disease worsening and brain lesions seen on MRI compared to Aubagio®?
– How safe is treatment with ofatumumab and how well is ofatumumab tolerated?
– How does ofatumumab affect the body?
Is there a way to predict how ofatumumab will help in the course of MS disease from results of special laboratory tests and MRI scans?
The use of Ofatumumab is investigational in this study, which means it has not been approved by FDA (Food and Drug Administration) for the treatment of people with relapsing MS. Ofatumumab is currently not “on the market” (available for you to receive a prescription for and/or to buy) for the treatment of MS in any country.
Ofatumumab is approved and ‘on the market’ for the treatment of Chronic Lymphocytic Leukemia (CLL), a cancer of the blood which affects a type of white blood cell called lymphocytes. However, for use in CLL, the dose is much higher than will be used in this study. In CLL, the medication is administered intravenously into a vein but for this MS research study, the medication will be given by an injection under the skin (subcutaneous injection).
Watch an excellent Multiple Sclerosis video HERE.
Apply for this study
If you would like to learn more about the different study opportunities you may call 1-800-530-0998 or for local callers please call 801-356-5555. To apply for this study, fill out the online application HERE.