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NCT00306592 · ClinicalTrials.gov registry record · Phase 3
Natalizumab Re-Initiation of Dosing
A Phase 3 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 404
- Enrollment target
NCT00306592: Completed Phase 3 study, sponsored by Biogen.
NCT00306592 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 404 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00306592, a Phase 3 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 404 participants
- Enrollment target
Study Summary
The primary objectives of this study are to further evaluate the safety of natalizumab (Tysabri®) monotherapy by evaluating the risk of hypersensitivity and immunogenicity following re-exposure to natalizumab, and to confirm the safety of switching to natalizumab from interferon beta (IFN-β), glatiramer acetate (GA), or other multiple sclerosis (MS) therapies.
Primary Outcome
AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child o
Interventions
- BIOLOGICAL BG00002 (natalizumab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 404 participants |
| Start Date | 2006-03 |
| Est. Completion | 2008-02 |
| Phase | Phase 3 |
What the finished NCT00306592 record still lists
NCT00306592 is an interventional study that assigns participants to a tested intervention. The registered 404 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which BG00002 (natalizumab) is the first listed.
NCT00306592 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00306592 about?
NCT00306592 is a clinical study titled "Natalizumab Re-Initiation of Dosing". The primary objectives of this study are to further evaluate the safety of natalizumab (Tysabri®) monotherapy by evaluating the risk of hypersensitivity and immunogenicity following re-exposure to natalizumab, and to confirm the safety of switching to natalizumab from interferon beta (IFN-β), glatir...
What is the current status of trial NCT00306592?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 404 participants. The study started on 2006-03. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00306592?
The interventions under investigation include: BG00002 (natalizumab) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00306592?
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 NCT00306592's enrollment target sits among peer trials
404 914th of 2000 higher than 1,084 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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