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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. — SELECTION  

Relapsing-Remitting Multiple Sclerosis Clinical Trial

Official title:
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)

Clinical Trial Summary

The primary objectives of this study are to assess the safety and immunogenicity of extended treatment with Daclizumab High Yield Process (DAC HYP). 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.

Clinical Trial Description

This study is an extension to the Daclizumab High Yield Process (DAC HYP) therapy from Study 205MS201 (NCT00390221) to evaluate the long-term safety, efficacy, and immunogenicity of DAC HYP in multiple sclerosis (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 205MS201, will continue DAC HYP therapy or resume DAC HYP therapy after a 6-month washout period in this study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00870740
Study type Interventional
Source Biogen
Contact
Status Completed
Phase Phase 2
Start date February 2009
Completion date October 2013
View Details
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