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NCT01064401 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis
A Phase 3 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,841
- Enrollment target
NCT01064401: Completed Phase 3 study, sponsored by Biogen.
NCT01064401 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 1,841 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (138% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01064401, a Phase 3 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,841 participants
- Enrollment target
Study 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.
Primary Outcome
Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. Only relapses confirmed by Independent Neurology Evaluation Committee (INEC) are included in this analysis. Adjusted ARR was estimated from a negative binomial regression model adjusted for the baseline relapse rate, history of prior IFN beta use, baseline Expanded Di
Interventions
- BIOLOGICAL Interferon beta-1a
- BIOLOGICAL BIIB019 (Daclizumab High Yield Process)
- DRUG Interferon beta-1a Placebo
- DRUG Daclizumab High Yield Process Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,841 participants |
| Start Date | 2010-05 |
| Est. Completion | 2014-07 |
| Phase | Phase 3 |
What the finished NCT01064401 record still lists
NCT01064401 is an interventional study that assigns participants to a tested intervention. Its 1,841 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (138% higher).
The record links to 0 conditions, and to 4 interventions - of which Interferon beta-1a is the first listed.
NCT01064401 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01064401 about?
NCT01064401 is a clinical study titled "Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis". 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 superior...
What is the current status of trial NCT01064401?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,841 participants. The study started on 2010-05. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01064401?
The interventions under investigation include: Interferon beta-1a (BIOLOGICAL), BIIB019 (Daclizumab High Yield Process) (BIOLOGICAL), Interferon beta-1a Placebo (DRUG), Daclizumab High Yield Process Placebo (DRUG).
Who is sponsoring clinical trial NCT01064401?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01064401's enrollment target sits among peer trials
1,841 114th of 2000 higher than 1,887 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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