Completed
PHASE3
INTERVENTIONAL
NCT01064401
Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis
View on ClinicalTrials.gov
Updated Dec 15, 2025
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.
Interventions
Name:
BIIB019 (Daclizumab High Yield Process)
Type:
BIOLOGICAL
Description:
Daclizumab High Yield Process for subcutaneous injection
Name:
Interferon beta-1a Placebo
Type:
DRUG
Description:
Placebo to interferon beta-1a intramuscular injection
Name:
Interferon beta-1a
Type:
BIOLOGICAL
Description:
Interferon beta-1a for intramuscular injection
Name:
Daclizumab High Yield Process Placebo
Type:
DRUG
Description:
Placebo to Daclizumab High Yield Process subcutaneous injection
Primary Outcomes
Measure:
Adjusted Annualized Relapse Rate (ARR)
TimeFrame:
Up to 144 weeks
Description:
Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. Only relapses confirmed by Independent Neurology Evaluation Committee (INEC) are included in this analysis. Adjusted ARR was estimated from a negative binomial regression model adjusted for the baseline relapse rate, history of prior IFN beta use, baseline Expanded Disability Status Scale score (EDSS; ≤ 2.5 vs \> 2.5) and baseline age (≤ 35 vs \> 35 years). Data after participants switched to alternative MS medications are excluded.
Trial Information
NCT ID
NCT01064401
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Biogen
Last Updated
December 15, 2025