DECIDE: Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon β 1a) in Patients with Relapsing-Remitting Multiple Sclerosis

Recruitment Period:
August 2010—ongoing

Location of Study/Trial :
MS Center at St. Elizabeth’s Medical Center
736 Cambridge Street
Boston, MA 02134

Recruiting:
Subjects ages 18-55 with relapsing-remitting MS, who are able to walk without any assistive aids, such as a cane or walker. Subjects must have had two or more clinical relapses within the previous 3 years with at least 1 clinical relapse in the 12 months prior to randomization OR one or more clinical relapses and one or more new MRI lesions within the previous 2 years.

Exclusion criteria
- Women who are pregnant and/or breast-feeding
- Subjects who have other serious medical conditions

Principal Investigator: 
Joshua Katz, MD, St. Elizabeth’s Medical Center, MS Center.
Ellen Lathi, MD, St. Elizabeth’s Medical Center, MS Center.

Sponsor: 
Biogen

Description of Study/Trial:
The purpose of this study is to compare daclizumab high-yield process (also called DAC HYP) to Avonex in the treatment of relapsing remitting MS. This study will also allow researchers to learn more about the safety of long-term treatment with DAC HYP in patients with MS.

Subjects will be seen by neurologists for cognitive testing, have routine MRIs, ECGs and blood draws during the study visits, which will be over 2-3 years depending on time of enrollment.

Subjects will be required to travel to St. Elizabeth’s Medical Center for appointments.