Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019

Status:	Terminated
Conditions:	Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:	Neurology, Other
Healthy:	No
Age Range:	18 - Any
Updated:	11/24/2018
Start Date:	February 15, 2013
End Date:	September 24, 2018

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

The primary objective of the study is to assess the safety and tolerability of long-term
treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants
with relapsing remitting multiple sclerosis (RRMS) who completed Study 205MS301
(NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).

Secondary objectives of this study in this study population are as follows:

To describe MS-related outcomes, including MS relapse, disability progression, MS lesion
formation, and participant-reported impact of MS, following long-term treatment with DAC HYP
To assess the long-term immunogenicity of DAC HYP administered by prefilled syringe (PFS) To
assess the safety, tolerability, and efficacy of switching to DAC HYP in participants
previously on long-term treatment with interferon β-1a (Avonex) in Study
205MS301(NCT01064401).

Enrollment will include up to 1600 Participants, this includes approximately 1200
Participants who completed Study 205MS301 (NCT01064401). Additionally, approximately 400
Participants from the other BIIB019 extension studies 205MS203 (NCT01051349) and 205MS302
(NCT01462318) will be eligible to enter Study 205MS303 at Week 144 of Study 205MS303 [Study
205MS301 (NCT01064401), study 205MS203 (NCT01051349) and study 205MS302 (NCT01462318) have
been referred to as parent studies in the protocol]. All Participants will receive the same
dose of DAC HYP as received in the parent studies; i.e., 150 mg by an SC injection every 4
weeks.

Key Inclusion Criteria:

- Must be a subject currently participating in Study 205MS301 (NCT01064401), or subject
currently participating in Study 205MS203 (NCT01051349) or Study 205MS302
(NCT01462318) who has completed End of Study Visit (Week 96 or later).

- Women of childbearing potential must practice effective contraception during the study
and be willing and able to continue contraception for 4 months after their last dose
of study treatment.

Key Exclusion Criteria:

- Any subject who permanently discontinued study treatment in Study 205MS301
(NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318) prior to
the end of the study treatment period, or had an Early Termination visit in Study
205MS301, Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).

- Any significant change in the subject's medical history that would preclude
administration of BIIB019, including laboratory tests or a current clinically
significant condition that, in the opinion of the Investigator, would have excluded
the subject's participation in Study 205MS301 (NCT01064401), Study 205MS203
(NCT01051349) or Study 205MS302 (NCT01462318).

The Investigator must re review the subject's medical fitness for participation and
consider any factors that would preclude treatment in this Study 205MS303.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

We found this trial at

sites

Clinical Trial Facility in Latham New York

Latham, New York 12110

from

Latham, NY