Research Study

Long-Term Extension Study in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of DAC HYP (EXTEND)
Principal Investigator 
Anthony Traboulsee

Overview

Body Locations and Systems 
Multiple Sclerosis
Health Conditions 
Multiple Sclerosis
ClinicalTrials.gov# 
NCT01797965
Status 
Closed to Recruitment
Study Start/End 
Feb 13, 2014 to Dec 31, 2019
Locations 
UBC Hospital
Name/Title 
Phoebe Allen, Research Coordinator
Phone 
604-822-1758
Email Address 
phoebe.allen@ubc.ca
Purpose of Study 

The primary objective of the study is to assess the safety and tolerability of long-term treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS) who completed Study 205MS301 (NCT01064401).

The secondary objectives of this study in this study population are as follows:

To assess the long-term immunogenicity of BIIB019
To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and participant-reported impact of MS, following long-term treatment with BIIB019
To assess the safety, tolerability, and efficacy of switching to BIIB019 in participants previously on long-term treatment with interferon β-1a in Study 205MS301 (NCT01064401)
To evaluate pharmacodynamic (PD) parameters that may be associated with treatment response

Eligibility 

Visit ClinicalTrials.gov for more information.

Disclaimer 

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers and email addresses are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician.