Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon ? 1a in Participants With Relapsing-Remitting Multiple Sclerosis (DECIDE)

The primary study objective is to test the superiority of Daclizumab High Yield Process (DAC HYP) compared to interferon β 1a (IFN β-1a) in preventing multiple sclerosis (MS) relapse in participants with relapsing remitting multiple sclerosis.

The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in slowing functional decline and disability progression and maintaining quality of life in this participant population.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Enrollment: 1841
Study Start Date: May 2010
Study Completion Date: July 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Daclizumab High Yield Process 150 mg SC
- Active Comparator: IFN β-1a 30 µg IM