Conditions: Relapsing-Remitting Multiple Sclerosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1841
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Daclizumab High Yield Process (DAC HYP) 150mg subcutaneous (SC) injection once every 4 weeks plus placebo to IFN β-1a intramuscular (IM) injection once weekly for 96 to 144 weeks arm 2: Interferon beta-1a (IFN β-1a) 30 µg IM once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks

Interventions: intervention 1: BIIB019 (Daclizumab High Yield Process) intervention 2: Interferon beta-1a Placebo intervention 3: Interferon beta-1a intervention 4: Daclizumab High Yield Process Placebo
Intervention descriptions: intervention 1: Daclizumab High Yield Process for subcutaneous injection intervention 2: Placebo to interferon beta-1a intramuscular injection intervention 3: Interferon beta-1a for intramuscular injection intervention 4: Placebo to Daclizumab High Yield Process subcutaneous injection

Protocol document: