Clinical Trial:

DECIDE study extension

Full Name

Multiple Sclerosis: A multicenter, open-label, extension study to evaluate the long-term safety and efficacy of BIIB019, daclizumab high yield process (DAC HYP), monotherapy in subjects with multiple sclerosis who have completed study 205MS301 (DECIDE OLE)(2_PRO00000843)

Description

This multicenter extension study will provide subjects who complete Study 205MS301 with the opportunity to receive open-label DAC HYP monotherapy for the evaluation of the long-term safety, efficacy, and immunogenicity of DAC HYP in subjects with relapsing-remitting MS. The study period will consist of baseline assessments, treatment open-label treatment with DAC HYP 150 mg SC using a PFS every 4 weeks (for up to approximately 3 years), and post-treatment safety follow-up visits (from approximately 4 to 24 weeks after the last dose of DAC HYP). Clinic visits will be scheduled every 4 weeks for the first 12 weeks in this study, followed by clinic visits scheduled every 12 weeks for up to approximately 3 years of continuous treatment.

Eligibility

Inclusion Criteria

o Must be a subject currently participating in Study 205MS301 who has completed either the Week 144 Visit or the End of Study Visit (Week 96).
o Cannot be pregnant or breastfeeding
o Must use adequate method of contraception for study duration and for 4 months after last dose of study treatment
o Appropriate blood levels