SUSTAIN (205MS305)
Research type
Research Study
Full title
A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) Switching from Natalizumab (SUSTAIN)
IRAS ID
220205
Contact name
Gavin Giovannoni
Contact email
Sponsor organisation
Biogen Idec Research Limited
Eudract number
2016-002820-10
Duration of Study in the UK
2 years, 1 months, 11 days
Research summary
The purpose of this study is to find out how effective the study drug daclizumab is when taken by patients that have relapsing multiple sclerosis (RMS) who have already been taking another medication called natalizumab. This study will look at whether the study drug is a suitable alternative treatment option for patients discontinuing natalizumab. The study will look at whether this drug can prevent symptoms of RMS relapse in patients who have been taking natalizumab and to evaluate its safety (side effects).
Each research participant taking part in the study will receive the study drug daclizumab once a month for up to 12 months. Study duration for each research participant will last for up to 16 months. 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 Multiple Sclerosis (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 100 research participants in about 40 study centres across the world, will take part in this study.REC name
London - Central Research Ethics Committee
REC reference
17/LO/0096
Date of REC Opinion
7 Apr 2017
REC opinion
Further Information Favourable Opinion