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NCT01797965 · ClinicalTrials.gov registry record · Phase 3
Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019
A Phase 3 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,501
- Enrollment target
NCT01797965 is a Phase 3 study that was terminated before completion, run by Biogen. The registered enrollment target is 1,501 participants.
The verdict
NCT01797965, a Phase 3 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,501 participants
- Enrollment target
Study 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 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).
Interventions
- DRUG BIIB019 (Daclizumab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,501 participants |
| Start Date | 2013-02-15 |
| Est. Completion | 2018-09-24 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01797965
The ClinicalTrials.gov registry entry for NCT01797965 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1,501 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 1 intervention - of which BIIB019 (Daclizumab) is the first listed.
NCT01797965 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01797965 about?
NCT01797965 is a clinical study titled "Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019". 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 (NCT01051...
What is the current status of trial NCT01797965?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,501 participants. The study started on 2013-02-15. Estimated completion is 2018-09-24.
What interventions are being tested in trial NCT01797965?
The interventions under investigation include: BIIB019 (Daclizumab) (DRUG).
Who is sponsoring clinical trial NCT01797965?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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