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Natalizumab High Titer Immunogenicity and Safety

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: BG00002-E (natalizumab high titer) (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen

Summary

The primary objective of the study was to evaluate the immunogenicity of natalizumab (TysabriŽ) 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.

Clinical Details

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

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Number of Participants With Anti-Natalizumab Antibody Negative, Transient Positive, and Persistent Positive Status

Secondary outcome:

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs

Mean Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at Week 36

Annualized Relapse Rate

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of a relapsing form of MS

- Must fall within the therapeutic indications stated in the locally approved label for

natalizumab

- Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

- Prior treatment with natalizumab

- Considered by investigator to be immunocompromised

- Other protocol-defined exclusion criteria may apply

Locations and Contacts

Research Site, Washington, District of Columbia 20007, United States

Research Site, Maitland, Florida 32751, United States

Research Site, Miami, Florida 33136, United States

Research Site, Atlanta, Georgia 30327, United States

Research Site, Farmington Hills, Michigan 48334, United States

Research Site, Buffalo, New York 14203, United States

Research Site, New York, New York 10003, United States

Research Site, Charlotte, North Carolina 28207, United States

Research Site, Philadelphia, Pennsylvania 19104, United States

Research Site, Pittsburgh, Pennsylvania 15212, United States

Research Site, Dallas, Texas 75214, United States

Research site, Round Rock, Texas 78681, United States

Research Site, Milwaukee, Wisconsin 53215, United States

Additional Information

Starting date: October 2006
Last updated: May 1, 2014

Page last updated: August 23, 2015

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