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NCT02881567 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab
A Phase 3 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 41
- Enrollment target
NCT02881567: Clinical Trial Phase 3 study, sponsored by Biogen.
NCT02881567 is a Phase 3 study that was terminated before completion, run by Biogen. The registered enrollment target is 41 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02881567, a Phase 3 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 41 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the effects of treatment with daclizumab on the proportion of participants relapse-free at 6 months in Relapsing-Remitting Multiple Sclerosis (RRMS) participants, who switched from treatment with natalizumab to daclizumab due to safety concerns. The secondary objectives of this study in this study population are to evaluate the effects of daclizumab on the following: 1) Multiple Sclerosis (MS) relapse activity including the annualized relapse rate (ARR) and the proportion of participants experiencing relapses requiring hospitalization and/or steroid treatment; 2) MS-related outcomes measured using magnetic resonance imaging (MRI); 3) Safety and tolerability in participants previously treated with natalizumab.
Primary Outcome
Relapses were 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. The Kaplan-Meier estimate of the percentage of participants relapse-free at Month 6 is reported.
Interventions
- DRUG Daclizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2017-04-18 |
| Est. Completion | 2018-09-12 |
| Phase | Phase 3 |
Why NCT02881567 stopped before completion
NCT02881567 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Daclizumab is the first listed.
NCT02881567 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02881567 about?
NCT02881567 is a clinical study titled "Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab". The primary objective of the study is to evaluate the effects of treatment with daclizumab on the proportion of participants relapse-free at 6 months in Relapsing-Remitting Multiple Sclerosis (RRMS) participants, who switched from treatment with natalizumab to daclizumab due to safety concerns. The ...
What is the current status of trial NCT02881567?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 41 participants. The study started on 2017-04-18. Estimated completion is 2018-09-12.
What interventions are being tested in trial NCT02881567?
The interventions under investigation include: Daclizumab (DRUG).
Who is sponsoring clinical trial NCT02881567?
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 NCT02881567's enrollment target sits among peer trials
41 1877th of 2000 higher than 123 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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