CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,841 enrolled
Drug / intervention
BIIB019 (Daclizumab High Yield Process) +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01064401
NCT01064401Phase 3Completed
CompareCT.gov

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

Biogen·interventional·Posted Feb 8, 2010·Updated Jul 11, 2016

In Brief

A Phase 3 clinical trial evaluating BIIB019 (Daclizumab High Yield Process), Interferon beta-1a Placebo, and 2 other interventions for Relapsing-Remitting Multiple Sclerosis. Completed, enrolled 1,841 participants across 228 sites in 28 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing-Remitting Multiple Sclerosis
CountriesArgentina, 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, United States
CollaboratorsAbbVie

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 8, 2010
Enrollment StartMay 1, 2010
Primary CompletionMar 1, 2014
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 16.4 years ago

Interventions

BIIB019 (Daclizumab High Yield Process)biological

Daclizumab High Yield Process for subcutaneous injection

Interferon beta-1a Placebodrug

Placebo to interferon beta-1a intramuscular injection

Interferon beta-1abiological

Interferon beta-1a for intramuscular injection

Daclizumab High Yield Process Placebodrug

Placebo to Daclizumab High Yield Process subcutaneous injection