Status:
TERMINATED
Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019
Lead Sponsor:
Biogen
Collaborating Sponsors:
AbbVie
Conditions:
Relapsing-Remitting Multiple Sclerosis
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 remi...
Detailed Description
Enrollment will include up to 1600 Participants, this includes approximately 1200 Participants who completed Study 205MS301 (NCT01064401). Additionally, approximately 400 Participants from the other B...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
February 15 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2018
Estimated Enrollment :
1501 Patients enrolled
Trial Details
Trial ID
NCT01797965
Start Date
February 15 2013
End Date
September 24 2018
Last Update
December 4 2019
Active Locations (222)
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1
Research Site
Phoenix, Arizona, United States, 85013
2
Research Site
Phoenix, Arizona, United States, 85050
3
Research Site
Tucson, Arizona, United States, 85704
4
Research Site
Little Rock, Arkansas, United States, 72205