Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: MS multiple sclerosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 621
Healthy volunteers: no

Brief summary:
The primary objective of this study is to determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52. The secondary objectives are to determine whether DAC HYP is effective in reducing the number of new gadolinium (Gd)-enhancing lesions, reducing the number of new or newly-enlarging T2 hyperintense lesions, reducing the proportion of participants with relapses, and improving quality of life.

Detailed description:

Arms:
arm 1: Participants will receive 3 subcutaneous (SC) injections of placebo every 4 weeks for up to 52 weeks. arm 2: Participants will receive 3 SC injections every 4 weeks for up to 52 weeks. arm 3: Participants will receive 3 SC injections every 4 weeks for up to 52 weeks.

Interventions: intervention 1: BIIB019 (Daclizumab High Yield Process) intervention 2: Placebo
Intervention descriptions: intervention 1: SC injection intervention 2: Placebo SC injection

Protocol document: