Natalizumab High Titer Immunogenicity and Safety
Public ClinicalTrials.gov record NCT00516893. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Open-Label Immunogenicity and Safety Study of Natalizumab High Titer Material (BG00002-E) in Subjects With Relapsing Forms of Multiple Sclerosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00516893
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 113 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2006
- Primary completion
- Sep 30, 2007
- Completion
- Nov 30, 2007
- Last update posted
- May 14, 2014
2006 – 2007
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Washington D.C. | District of Columbia | 20007 | — |
| Research Site | Maitland | Florida | 32751 | — |
| Research Site | Miami | Florida | 33136 | — |
| Research Site | Atlanta | Georgia | 30327 | — |
| Research Site | Farmington Hills | Michigan | 48334 | — |
| Research Site | Buffalo | New York | 14203 | — |
| Research Site | New York | New York | 10003 | — |
| Research Site | Charlotte | North Carolina | 28207 | — |
| Research Site | Philadelphia | Pennsylvania | 19104 | — |
| Research Site | Pittsburgh | Pennsylvania | 15212 | — |
| Research Site | Dallas | Texas | 75214 | — |
| Research site | Round Rock | Texas | 78681 | — |
| Research Site | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00516893, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 14, 2014 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00516893 live on ClinicalTrials.gov.