Natalizumab High Titer Immunogenicity and Safety

Completed · Phase 2

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT00516893

Run by

Biogen

People needed

113

Starts

2006-10-01

Expected to finish

2007-12-01

Last updated by the study team

2014-05-15

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Prior treatment with natalizumab
• Considered by investigator to be immunocompromised
• Other protocol-defined exclusion criteria may apply

Where it is running

• 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
• Research Site — Dallas, Texas, United States
• Research site — Round Rock, Texas, United States
• Research Site — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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