Daclizumab Long-Term Safety and Efficacy Extension Study in MS

• Research type

  Research Study

• Full 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)

• IRAS ID

  43824

• Contact name

  Cris Constantinescu

• Sponsor organisation

  Biogen Idec Ltd.

• Eudract number

  2009-015318-23

• ISRCTN Number

  Not available

• Research summary

  AN EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, EFFICACY AND IMMUNOGENICITY OF DACLIZUMAB HYP (DAC HYP) IN MULTIPLE SCLEROSIS (MS) This is a open-label extension of the 205MS202 study (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)) The purpose of this extension study is to expand the evaluation of safety, efficacy and immunogenicity of DAC HYP in MS that is provided in Studies 205MS201 and 205MS202 which were double-blind. Long-term evaluation of DAC HYP is necessary given its potential to be used long-term in MS. This study will be open-label, unlike the previous studies of 205MS201 and 205MS202, as all participants will now be administering the same dose of DAC HYP every 4 weeks (150mg subcutaneously). In Study 205MS202, 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 205MS202 at which time further participation in 205MS202 will cease and study treatment will continue as described in the protocol. This trial is designed to allow subjects who complete 205MS201 and 205MS202 to remain on open-label DAC HYP monotherapy for an additional three years in order to collect long-term treatment information to inform the assessment of risk and benefit of DAC HYP in the management of relapsing-remitting MS.

• REC name

  North East - York Research Ethics Committee

• REC reference

  10/H0903/7

• Date of REC Opinion

  26 Mar 2010

• REC opinion

  Further Information Favourable Opinion