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NCT00516893 · ClinicalTrials.gov registry record · Phase 2
Natalizumab High Titer Immunogenicity and Safety
A Phase 2 study of Multiple Sclerosis, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 113
- Enrollment target
- 13
- Study locations
NCT00516893: Completed Phase 2 study of Multiple Sclerosis, sponsored by Biogen.
NCT00516893 is a Phase 2 study of Multiple Sclerosis that has completed, run by Biogen. The registered enrollment target is 113 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (81% lower). The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00516893, a Phase 2 study of Multiple Sclerosis, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 113 participants
- Enrollment target
- 13
- Study locations
Study Summary
The primary objective of the study was to evaluate the immunogenicity of natalizumab (Tysabri®) produced by a modified manufacturing process (natalizumab high titer; BG00002-E) administered intravenously (IV) to participants with relapsing forms of multiple sclerosis (MS). The secondary objective of this study was to evaluate the safety of natalizumab high titer.
Primary Outcome
Negative: no detectable antibody at all post-baseline visits. Persistent positive: antibody positive at 2 or more post-baseline visits at least 42 days apart, or positive at the last post-baseline visit. Transient positive: antibody positive at only 1 post-baseline visit prior to the last visit.
Conditions Studied
Interventions
- BIOLOGICAL BG00002-E (natalizumab high titer)
Study Locations (13)
Florida
- Research Site - Maitland
- Research Site - Miami
New York
- Research Site - Buffalo
- Research Site - New York
Pennsylvania
- Research Site - Philadelphia
- Research Site - Pittsburgh
Texas
- Research Site - Dallas
- Research site - Round Rock
District of Columbia
- Research Site - Washington D.C.
Georgia
- Research Site - Atlanta
Michigan
- Research Site - Farmington Hills
North Carolina
- Research Site - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2006-10 |
| Est. Completion | 2007-12 |
| Phase | Phase 2 |
What the finished NCT00516893 record still lists
NCT00516893 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which BG00002-E (natalizumab high titer) is the first listed.
NCT00516893 lists 13 locations in 9 states (Florida, New York, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT00516893 about?
NCT00516893 is a clinical study titled "Natalizumab High Titer Immunogenicity and Safety". The primary objective of the study was to evaluate the immunogenicity of natalizumab (Tysabri®) produced by a modified manufacturing process (natalizumab high titer; BG00002-E) administered intravenously (IV) to participants with relapsing forms of multiple sclerosis (MS). The secondary objective of...
What is the current status of trial NCT00516893?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 113 participants. The study started on 2006-10. Estimated completion is 2007-12.
What conditions does trial NCT00516893 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT00516893?
The interventions under investigation include: BG00002-E (natalizumab high titer) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00516893?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00516893 being conducted?
This trial has 13 study locations across District of Columbia, Florida, Georgia, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00516893's enrollment target sits among peer trials
113 121st of 315 higher than 195 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis 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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