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A Multicenter, Open-Label Immunogenicity and Safety Study of Natalizumab High Titer Material (BG00002-E) in Subjects With Relapsing Forms of Multiple Sclerosis
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.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
No
Research Site
Washington D.C., District of Columbia, United States
Research Site
Maitland, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Farmington Hills, Michigan, United States
Research Site
Buffalo, New York, United States
Research Site
New York, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Start Date
October 1, 2006
Primary Completion Date
October 1, 2007
Completion Date
December 1, 2007
Last Updated
May 15, 2014
113
ACTUAL participants
BG00002-E (natalizumab high titer)
BIOLOGICAL
Lead Sponsor
Biogen
Collaborators
NCT07225504
NCT06276634
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06809192