Daclizumab Safety and Efficacy Extension Study in Multiple Sclerosis

• Research type

  Research Study

• Full 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) - Protocol Number 205MS202

• IRAS ID

  15937

• Sponsor organisation

  Biogen Idec

• Eudract number

  2008-005559-46

• ISRCTN Number

  NA

• Research summary

  An extension study to evaluate the long-term safety, efficacy and immunogenicity of Daclizumab Hyp in multiple sclerosis. This is a double-blind extension of the 205-MS-201 study (Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects with Relapsing (exacerbations) Remitting (periods of full/partial recovery) Multiple Sclerosis.The purpose of this extension study is to expand the evaluation of safety, efficacy, and immunogenicity (ability to invoke an immune response) of DAC HYP in MS that's provided in Study 205MS201. Long-term evaluation of DAC HYP is necessary given its potential to be used long-term in MS. A systematic evaluation of the washout period, as provided by the randomized withdrawal design of this study, is necessary to determine the impact of treatment discontinuation after the use of DAC HYP in MS. The double-blind from study 205MS201 will be maintained throughout this study to ensure data integrity.In Study 205MS201, study treatment is scheduled to stop at the Week 52 visit, and all subjects will be followed during a washout period between Week 52 and the final study visit at Week 72. Subjects may enter this extension study at the Week 52 visit of 205MS201 at which time further participation in 205MS201 will cease and study treatment will continue as described in this protocol. This extension study is designed to provide for the initiation of active therapy with DAC HYP to subjects who received placebo between Weeks 0 through 52 in Study 205MS201. In addition, in subjects who received active therapy with DAC HYP between Weeks 0 through 52 in Study 205MS201, this study will provide for either continued therapy with DAC HYP or for re-initiation of DAC HYP therapy after a 6-month washout period.

• REC name

  North East - York Research Ethics Committee

• REC reference

  09/H0903/20

• Date of REC Opinion

  18 May 2009

• REC opinion

  Further Information Favourable Opinion