Ignite Creation Date:
2024-05-05 @ 10:14 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01064401
Status:
COMPLETED
Last Update Posted:
2016-07-11
First Post:
2010-01-26
Brief Title:
Efficacy and Safety of BIIB019 Daclizumab High Yield Process Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
Multicenter Double-blind Randomized Parallel-group Monotherapy Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process DAC HYP Versus Avonex Interferon β 1a in Patients With Relapsing-Remitting Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DECIDE
Brief Summary:
The primary study objective is to test the superiority of Daclizumab High Yield Process DAC HYP compared to interferon β 1a IFN β-1a in preventing multiple sclerosis MS relapse in participants with relapsing remitting multiple sclerosis
The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in slowing functional decline and disability progression and maintaining quality of life in this participant population
The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in slowing functional decline and disability progression and maintaining quality of life in this participant population
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2009-012500-11 | None | None | None |