Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 3 study, sponsored by Biogen.
NCT01797965 is a Phase 3 study that was terminated before completion, run by Biogen. The registered enrollment target is 1,501 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. A SAE is any untoward medical occurrence or effect that at any dose results in death, i
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 |
Why NCT01797965 stopped before completion
NCT01797965 is an interventional study that assigns participants to a tested intervention. Its 1,501 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 (94% higher).
The record links to 0 conditions, and to 1 intervention - of which BIIB019 (Daclizumab) is the first listed.
NCT01797965 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01797965's enrollment target sits among peer trials
1,501 158th of 2000 higher than 1,843 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00178724 · 1,500 participants
Spinal Cord Injury Registry - North American Clinical Trials Network
- NCT00951366 · 1,500 participants
Preterm Lung Patient Registry
- NCT01050504 · 1,500 participants
Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate or Bladder/Urothelial Cancer
- NCT02071134 · 1,500 participants
Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI