Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019
Public ClinicalTrials.gov record NCT01797965. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01797965
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,501 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 15, 2013 (Actual)
- Primary completion
- Sep 24, 2018 (Actual)
- Completion
- Sep 24, 2018 (Actual)
- Last update posted
- Dec 4, 2019
2013 – 2018
United States locations
- U.S. sites
- 39
- U.S. states
- 23
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Phoenix | Arizona | 85013 | — |
| Research Site | Phoenix | Arizona | 85050 | — |
| Research Site | Tucson | Arizona | 85704 | — |
| Research Site | Little Rock | Arkansas | 72205 | — |
| Research Site | La Jolla | California | 92037 | — |
| Research Site | Aurora | Colorado | 80045 | — |
| Research Site | Centennial | Colorado | 80112 | — |
| Research Site | Naples | Florida | 34102 | — |
| Research Site | Pompano Beach | Florida | 33060 | — |
| Research Site | Atlanta | Georgia | 30327 | — |
| Research Site | Fort Wayne | Indiana | 46804 | — |
| Research Site | Indianapolis | Indiana | 46202 | — |
| Research Site | Kansas City | Kansas | 66160 | — |
| Research Site | Lexington | Kentucky | 40503 | — |
| Research Site | Wellesley | Massachusetts | 02481 | — |
| Research Site | Worcester | Massachusetts | 01605 | — |
| Research Site | Farmington Hills | Michigan | 48334 | — |
| Research Site | Lebanon | New Hampshire | 03756 | — |
| Research Site | Albuquerque | New Mexico | 87131 | — |
| Research Site | Buffalo | New York | 14203 | — |
| Research Site | Latham | New York | 12110 | — |
| Research Site | New York | New York | 10016 | — |
| Research Site | New York | New York | 10065 | — |
| Research Site | Rochester | New York | 14642 | — |
| Research Site | Charlotte | North Carolina | 28207 | — |
| Research Site | Raleigh | North Carolina | 27607 | — |
| Research Site | Winston-Salem | North Carolina | 27103 | — |
| Research Site | Dayton | Ohio | 45408 | — |
| Research Site | Medford | Oregon | 97504 | — |
| Research Site | Portland | Oregon | 97225 | — |
| Research Site | Allentown | Pennsylvania | 18103 | — |
| Research Site | Pittsburgh | Pennsylvania | 15213 | — |
| Research Site | Cordova | Tennessee | 38018 | — |
| Research Site | Franklin | Tennessee | 37064 | — |
| Research Site | Knoxville | Tennessee | 37922 | — |
| Research Site | Round Rock | Texas | 78681 | — |
| Research Site | Henrico | Virginia | 23226 | — |
| Research Site | Tacoma | Washington | 98405 | — |
| Research Site | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 183 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01797965, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 4, 2019 · Synced Nov 4, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01797965 live on ClinicalTrials.gov.