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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 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 1,841 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01064401
The ClinicalTrials.gov registry entry for NCT01064401 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,841 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Interferon beta-1a is the first listed.
NCT01064401 reports 0 study locations.
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.
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