BG00012 Monotherapy Safety and Efficacy Extension Study in MS

• Research type

  Research Study

• Full title

  A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects with Relapsing-Remitting Multiple Sclerosis

• IRAS ID

  21202

• Sponsor organisation

  Biogen Idec

• Eudract number

  2008-004753-14

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  A PHASE 3B EXTENSION STUDY IN SUBJECTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS (MS) TO EVALUATE THE LONG-TERM SAFETY PROFILE OF BG00012 This study will extend BG00012 therapy from two previous Phase 3 studies, and will further evaluate the long-term safety and efficacy profile of BG00012. Long-term evaluation of BG00012 is necessary given its potential for long-term administration in the treatment of MS. This is a multicenter, parallel-group, randomised, dose-blind, dose-comparison study. Approximately 1700 subjects will be randomised at approximately 375 sites in North America, Europe and the rest of the world. Eligible subjects from the previous 2 studies will be enrolled into this extension study and will be followed for at least 1 year and possibly up to 2 years, assuming BG00012 continues to have a positive benefit/risk ratio. The dosage for the extension study will be the same as used in the previous Phase 3 studies; however, it is a dose-blind study meaning that neither the study staff nor participants will know which dose of BG00012 the subject is taking. Eligible subjects will be enrolled at the final visit of their previous BG00012 study, and will report to the study site every 4 weeks for the first 24 weeks, and every 12 weeks thereafter for up to 2 years. Subjects will undergo efficacy assessments (relapse assessment, MRI), health economic assessments and safety assessments. The study will be conducted at 7 sites across England (through the Neurology Departments at the NHS hospitals).

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  09/H0505/94

• Date of REC Opinion

  8 Oct 2009

• REC opinion

  Further Information Favourable Opinion