BENEFIT 15
Research type
Research Study
Full title
BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies
IRAS ID
230388
Contact name
Jonathan O'Riordan
Contact email
Sponsor organisation
Bayer AG
Eudract number
2017-001176-31
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
2017-001176-31, EudraCT
Duration of Study in the UK
0 years, 6 months, 29 days
Research summary
Multiple sclerosis (MS) is a condition of the central nervous system. In MS, the coating around nerve fibres (called myelin) is damaged, causing a range of symptoms.
Around 100,000 people in the UK have MS. It's normally diagnosed in people between the ages of 20 and 40, and affects almost twice as many women as men. Although there is no cure for MS, various drugs and therapies may reduce the number of flare ups and can help to ease symptoms and disability.This observational study may include all patients who were randomised into and treated at least once in the former BENEFIT Study 304747. The study does not involve a treatment for any condition and is for research purposes only.
The purpose of this study is to obtain long-term clinical data from patients approximately 15 years after their first clinical event, who participated in the former BENEFIT 304747 study and were treated at least once within that study.
Participation in this study will involve a single clinical and MRI follow-up assessment visit. If a patient is unable to travel for this visit, an alternative option of a telephone assessment is also available.
This study will collect information on evolution of the patients’ disease, including changes in disability, relapses and mental function over time, and the healthcare resource utilisation (i.e. resource use, employment status), in relation to their treatment. In addition, patients’ will also be asked to have a brain magnetic resonance imaging (also known as an MRI), and provide a blood sample. Finally the study will also collect data on quality of life (QoL), treatment history and current Multiple Sclerosis specific medication, and possible fatigue and depression.
REC name
West of Scotland REC 1
REC reference
17/WS/0169
Date of REC Opinion
16 Oct 2017
REC opinion
Further Information Favourable Opinion