Extension Study of BIIB017 in Multiple Sclorosis (MS) Patients
Research type
Research Study
Full title
A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis
IRAS ID
106273
Contact name
Cris S Constantinescu
Sponsor organisation
Biogen Idec - UK
Eudract number
2010-024477-39
Clinicaltrials.gov Identifier
Research summary
Multiple Sclerosis (MS) is a chronic disease of the central nervous system (CNS). Although there is still no cure for MS, effective therapies are available to modify the disease course and treat exacerbations, such as interferon beta and Copaxone (glatiramer acetate). Biogen Idec (the sponsor) is developing a new drug called BIIB017 for MS. BIIB017 is being developed to increase convenience and improve treatment compliance. The purpose of this extension study is to find out more about potential side effects of BIIB017 and the clinical course of multiple sclerosis in patients who continue to take BIIB017 after completing study 105MS301. Participants will continue to administer BIIB017 at the same dose they received in their second treatment year of Study 105MS301. All participants will receive treatment with BIIB017 125 mcg subcutaneously (ie. Injection under the skin) every 2 or 4 weeks (the latter group alternating injections with placebo every 2 weeks). Patients who experience disease progression or suffer a relapse will be eligible to switch to treatment with an approved open-label MS therapy at any time during the study. To be eligible to participate in this study, participants must understand the purpose and risks of the study, provide informed consent, completed the study treatment and 96 week visit schedule in the 105MS301 study, and practice effective contraception. The study involves: Screening Phase up to 6 weeks Treatment phase up to 96 weeks End of study Follow up visit at week 100 Relapse evaluations (if applicable) Patients will keep a diary of their MS symptoms, complete questionnaires, visit hospital to give blood/urine samples as well as less frequent tests such as MRI scans to assess their well being over the course of the study. The aim is for the 13 patients randomised into 105MS301 across 4 sites in the UK to rollover into the extension study.
REC name
West of Scotland REC 1
REC reference
12/WS/0145
Date of REC Opinion
7 Aug 2012
REC opinion
Further Information Favourable Opinion