Efficacy & safety of ofatumumab vs teriflunomide in RMS (OMB2302)
Research type
Research Study
Full title
A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing forms of multiple sclerosis
IRAS ID
208610
Contact name
Eli Silber
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2015-005419-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 8 months, 12 days
Research summary
Multiple Sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system. People with relapsing MS (relapsing-remitting MS or secondary progressive MS with relapses) will have repeated attacks, or "relapses". During these relapses, a person's own immune system attacks the nerves in the brain/spinal chord and damages the myelin covering. The immune system is made up difference types of cells that work to fight infection - including B-cells and lymphocytes. Ofatumumab (the drug being investigated in this study) works by temporarily removing the number of B-cells, while teriflunomide (the drug Ofatumumab is being compared to in this study) works by limiting the increase of lymphocytes. B-cells and lymphocytes are involved in the process of inflammation that is believed to play a role in damaging the myelin and in some of the symptoms of MS.
The main purpose of this study is to see how effective ofatumumab is in reducing relapses compared to teriflunomide. Ofatumumab is administered as an injection under the skin once every 4 weeks, whilst teriflunomide is a tablet taken orally once a day. All study participants will receive either ofatumumab or teriflunomide, as well as a matching placebo. The maximum treatment duration for any participant will be 30 months.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
16/SC/0391
Date of REC Opinion
11 Oct 2016
REC opinion
Further Information Favourable Opinion