NCT00870740

Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Participants With Multiple Sclerosis Who Have Completed Study 205MS201 (NCT00390221) to Treat Relapsing-Remitting Multiple Sclerosis

A Double-Blind, Multicenter, Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS201 (SELECT)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 517 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study was to assess the safety and immunogenicity of extended treatment with DAC HYP. This evaluation included the following major components: * An assessment of safety and immunogenicity of extended treatment with DAC HYP when administered to MS subjects who had completed 52 weeks of active therapy with DAC HYP in Study 201. * An assessment of safety and immunogenicity during a 6-month washout period from DAC HYP. * An assessment of safety and immunogenicity during reinitiation of therapy with DAC HYP after a 6-month washout period. * An assessment of safety and immunogenicity of DAC HYP when administered to MS subjects who previously received placebo during Study 201. The secondary objective is to assess the durability of the effect of DAC HYP on multiple sclerosis (MS) disease activity as measured by brain magnetic resonance imaging (MRI) scans and clinical MS relapses.

Detailed description

This study, an extension to Study 205MS201 (NCT00390221), will evaluate the long-term safety, efficacy, and immunogenicity of DAC HYP in MS. In Study 205MS201, study treatment was scheduled to stop at the Week 52 visit. This extension study will provide for the initiation of active therapy with DAC HYP among participants who received placebo during Weeks 0 through 52 in 205MS201. In addition, participants who received active therapy with DAC HYP during Weeks 0 through 52 in Study 205MS201 will continue DAC HYP therapy or resume DAC HYP therapy after a 6-month washout period in this study.

Conditions

• Relapsing-Remitting Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	BIIB019 (Daclizumab High Yield Process)	SC injection
DRUG	Placebo	Placebo SC injection

Timeline

• Start date: 2009-02-01
• Primary completion: 2012-05-01
• Completion: 2012-10-01
• First posted: 2009-03-27
• Last updated: 2016-08-30
• Results posted: 2016-08-30

Locations

58 sites across 8 countries: Czechia, Germany, Hungary, India, Poland, Russia, Ukraine, United Kingdom