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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 C

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Trial Conditions
  • Relapsing-Remitting Multiple Sclerosis
  • Multiple Sclerosis
What is the purpose of this trial?

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). The secondary objectives of this study in this study population are as follows: - To assess the long-term immunogenicity of BIIB019 - To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and participant-reported impact of MS, following long-term treatment with BIIB019 - To assess the safety, tolerability, and efficacy of switching to BIIB019 in participants previously on long-term treatment with interferon β-1a in Study 205MS301 (NCT01064401) - To evaluate pharmacodynamic (PD) parameters that may be associated with treatment response

Date & Status

Enrolling by invitation

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

Key Inclusion Criteria:

- Must be a subject currently participating in Study 205MS301 (NCT01064401) 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) prior to the end of the study treatment period, or had an Early
Termination visit in Study 205MS301.

- 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). 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.

Gender: Both
Steward Physician(s)
  • Medical Director
Trial Interventions
Drug
  • BIIB019 (Daclizumab High Yield Process)
Physician Researcher

Investigator Name:

  • Medical Director

Other Information

Sponsor: Biogen Idec
Phase: Phase 3
Trial ID: NCT01797965
Volunteers:  Not Accepting Healthy Volunteers

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