CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 410 enrolled
Drug / intervention
BIIB019 (Daclizumab) +1 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/NCT01051349
NCT01051349Phase 2Completed
CompareCT.gov

A Multicenter, Open-label, Extension Study to Evaluate the Long Term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION)

Biogen·interventional·Posted Jan 18, 2010·Updated Nov 9, 2018

In Brief

A Phase 2 clinical trial evaluating BIIB019 (Daclizumab) and trivalent seasonal influenza vaccine for Relapsing-Remitting Multiple Sclerosis. Completed, enrolled 410 participants across 65 sites in 8 countries.

Detailed Summary

Primary Objective is to assess the safety of extended treatment with Daclizumab High Yield Process (DAC HYP, BIIB019) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS). Secondary Objective is to assess the long-term immunogenicity of DAC HYP and to assess the durability of response to DAC HYP in preventing multiple sclerosis (MS) relapse, slowing disability progression, and reducing new MS lesion formation in this study population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing-Remitting Multiple Sclerosis
CountriesCzechia, Germany, Hungary, India, Poland, Russia, Ukraine, United Kingdom
CollaboratorsAbbVie

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 18, 2010
Enrollment StartMar 31, 2010
Primary CompletionAug 25, 2016
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 16.5 years ago

Interventions

BIIB019 (Daclizumab)biological

Administered as specified in the treatment arm.

trivalent seasonal influenza vaccinebiological

All participants who participate in the 2013-2014 influenza vaccine substudy will receive the vaccine at the study site