Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing Remitting Multiple Sclerosis
Extended DAC HYP monotherapy from study 205MS202 in order to evaluate long term safety and efficacy of DAC HYP in subjects with relapsing remitting multiple sclerosis (MS).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- To assess the safety of extended treatment with DAC HYP monotherapy and the long term immunogenicity of DAC HYP, AEs, laboratory evaluations, vital signs, physical examinations, and immunogenicity (the incidence of development of antibodies to DAC HYP) [ Time Frame: 144 weeks ] [ Designated as safety issue: Yes ]
- The durability of DAC HYP measured by brain MRI (new gd enhancing lesions, new or newly enlarging T2 hyperintense lesions, vol of new T1 hypointense lesions; total lesion vol of T2 hyperintense lesions; vol of non gd enhancing T1 hypointense lesions [ Time Frame: 144 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Drug: Daclizumab HYP
This study will provide subjects who complete Study 205MS202 with the option to receive continued open-label DAC HYP monotherapy and to evaluate the long-term safety, efficacy, and immunogenicity of DAC HYP monotherapy in subjects with RRMS.
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