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NCT01058005 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis
A Phase 3 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 84
- Enrollment target
NCT01058005: Clinical Trial Phase 3 study, sponsored by Biogen.
NCT01058005 is a Phase 3 study that was terminated before completion, run by Biogen. The registered enrollment target is 84 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01058005, a Phase 3 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 84 participants
- Enrollment target
Study Summary
This was a multicenter, randomized, open-label, parallel-group, active-controlled study. Prior to randomization, participants were to have been treated with glatiramer acetate or interferon β-1a (44 μg). Participants were to be randomized to receive natalizumab, interferon β-1a 44 μg, or glatiramer acetate.
Primary Outcome
An SAE was defined as any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event; however, this does not include an event that, had it occurred in a more severe form, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An S
Interventions
- DRUG glatiramer acetate
- DRUG BG00002 (natalizumab)
- DRUG interferon beta-1a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2010-03 |
| Est. Completion | 2012-04 |
| Phase | Phase 3 |
Why NCT01058005 stopped before completion
NCT01058005 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 3 interventions - of which glatiramer acetate is the first listed.
NCT01058005 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01058005 about?
NCT01058005 is a clinical study titled "Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis". This was a multicenter, randomized, open-label, parallel-group, active-controlled study. Prior to randomization, participants were to have been treated with glatiramer acetate or interferon β-1a (44 μg). Participants were to be randomized to receive natalizumab, interferon β-1a 44 μg, or glatiramer ...
What is the current status of trial NCT01058005?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 84 participants. The study started on 2010-03. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01058005?
The interventions under investigation include: glatiramer acetate (DRUG), BG00002 (natalizumab) (DRUG), interferon beta-1a (DRUG).
Who is sponsoring clinical trial NCT01058005?
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 NCT01058005's enrollment target sits among peer trials
84 1749th of 2000 higher than 250 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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