MA30143 - Ocrelizumab in patients with Multiple Sclerosis
Research type
Research Study
Full title
AN OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH EARLY STAGE RELAPSING REMITTING MULTIPLE SCLEROSIS
IRAS ID
217768
Contact name
Martin Duddy
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2016-002937-31
Duration of Study in the UK
5 years, 0 months, 15 days
Research summary
Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating, and degenerative disease of the central nervous system (CNS) that affects approximately 2.3 million worldwide.
Disease-modifying treatments(DMTs) are used to slow the development of MS-related neurological damage and disability progression.
Suppression of disease activity and disability progression as early as possible remains an important goal of therapy in MS because what is lost in MS cannot typically be regained. The potential risk of irreversible disease progression is therefore an important factor in the treatment decision making of patients and their doctors. Although there are now several approved therapies for RMS, some lack sufficient efficacy to adequately slow progression of disability, while more effective therapies are often reserved for later use because of serious risks. Thus there remains a need for a highly effective therapy with a benefit-risk profile that supports its expeditious use at any time during the course of disease to preserve neurological function, stem accrual of irreversible disability, and improve quality of life for people living with MS.
Ocrelizumab is a recombinant humanized anti-human monoclonal antibody that selectively targets and eliminates CD20-expressing B cells, which are believed to play a critical role in MS.
Given the evidence on the potential long term benefits of early treatment of RRMS with DMTs, and given the favourable risk: benefit profile of ocrelizumab to date, it will be valuable to characterise the clinical profile of ocrelizumab in early RRMS patients. As there is limited data on the effectiveness of ocrelizumab in this population, a dedicated prospective study to specifically evaluate the clinical profile is required and justified.
A total of 600 patients with RRMS will be enrolled globally with 48 anticipated in the UK across 12 sites.
The study is sponsored by F. Hoffman-La Roche Ltd.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
17/NE/0165
Date of REC Opinion
7 Sep 2017
REC opinion
Further Information Favourable Opinion