215MS202 Efficacy & Safety of BIIB033 as an Add-on Therapy in RMS
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies (AFFINITY)
IRAS ID
234065
Contact name
Basil Sharrack
Contact email
Sponsor organisation
Biogen Idec Research Limited
Eudract number
2017-001224-22
Duration of Study in the UK
2 years, 10 months, 0 days
Research summary
Multiple sclerosis (MS) is linked to brain or spinal cord damage. In MS, the body’s defense system reacts against its own myelin – the ‘insulation’ that surrounds nerve fibres. When myelin is damaged, the messages between the brain and other parts of the body are disrupted. BIIB033 is being investigated to see if it can promote regeneration of myelin (called remyelination).
MS treatments aim to control the inflammatory aspects of the disease. These may reduce the frequency/severity of relapses and the accumulation of physical disability by ‘dampening’ the immune system. However, any nerves that are already affected remain damaged. The drug being studied in this study, BIIB033, may repair the nerves damaged by MS.
The main purpose of this study is to evaluate the efficacy (how well the study drug works) and safety (side effects) of BIIB033 in patients with Relapsing Multiple Sclerosis (RMS), who are already receiving anti-inflammatory treatment for their condition. Each participant taking part in the study is put into one of two groups and each group is given a different treatment (BIIB033 or placebo). Each participant will receive study drug Intravenously (IV), once every 4 weeks for a total of 19 doses over 18 months. Study duration for each research participant will last for up to 22 months in total. Participants will be required to undergo a series of study assessments during the visits including the collection of blood samples and approximately 5 MRI scans to check the patients MS.
There are no guaranteed benefits for patients participating in this study. However, the information collected in this study may help other patients with MS in the future.
The study is sponsored by Biogen Idec Research Limited. Around 240 research participants at approximately 150 sites in approximately 25 countries across the world, will take part in this study.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
17/EM/0361
Date of REC Opinion
28 Dec 2017
REC opinion
Further Information Favourable Opinion