EXTENDA Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301

BIIB019 (Daclizumab)

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Annualized Relapse Rate (ARR) in the 205MS303 Treatment Period

ARR in the 205MS301-303 Combined Study Period and 205MS301 Treatment Period

Number of Participants With Relapse in the 205MS303 Treatment Period

Number of Participants With Relapse in the 205MS301-303 Combined Study Period

Number of Participants With Sustained Disability Progression in the 205MS303 Treatment Period

Number of Participants With Sustained Disability Progression in the 205MS301-303 Combined Study Period

Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period

Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS301 Treatment Period

Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period

Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period

Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period

Number of Participants With New T1 Hypointense Lesions in the 205MS301 Treatment Period

Percent Change in Brain Volume From the 205MS303 Baseline

Percent Change in Brain Volume From 205MS301 Baseline

Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period

Change From Baseline in the Multiple Sclerosis Functional Composite (MSFC) Score in the 205MS303 Treatment Period

Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period

Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period

Number of Participants Who Are Free From Disease Activity in the 205MS303 Treatment Period

Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period

Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period

Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period

Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period

Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period

Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period

Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period

HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period

HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period

HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period

HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period

HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period

HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period

HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period

Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Assessments in the 205MS303 Treatment Period

Local Tolerability as Assessed by Participant-reported Injection Site Pain VAS

Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories

Number of Participants With Anti-BIIB019 Binding Antibodies (ADAbs) in the 205MS303 Treatment Period

Number of Participants With Anti-BIIB019 Neutralizing Antibodies (Nabs) in the 205MS303 Treatment Period

Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period

Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period

Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period

Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period