NCT01064401

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,841 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsing-Remitting Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	BIIB019 (Daclizumab High Yield Process)	Daclizumab High Yield Process for subcutaneous injection
DRUG	Interferon beta-1a Placebo	Placebo to interferon beta-1a intramuscular injection
BIOLOGICAL	Interferon beta-1a	Interferon beta-1a for intramuscular injection
DRUG	Daclizumab High Yield Process Placebo	Placebo to Daclizumab High Yield Process subcutaneous injection

Timeline

• Start date: 2010-05-01
• Primary completion: 2014-03-01
• Completion: 2014-07-01
• First posted: 2010-02-08
• Last updated: 2016-07-11
• Results posted: 2016-07-11

Locations

228 sites across 28 countries: United States, Argentina, Australia, Brazil, Canada, Czechia, Denmark, Finland, France, Georgia, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Mexico, Moldova, Poland, Romania, Russia, Serbia, Spain, Sweden, Switzerland, Ukraine, United Kingdom