Natalizumab Re-Initiation of Dosing

Completed · Phase 3

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

The primary objectives of this study are to further evaluate the safety of natalizumab (Tysabri®) monotherapy by evaluating the risk of hypersensitivity and immunogenicity following re-exposure to natalizumab, and to confirm the safety of switching to natalizumab from interferon beta (IFN-β), glatiramer acetate (GA), or other multiple sclerosis (MS) therapies.

Key facts

Study ID

NCT00306592

Run by

Biogen

People needed

404

Starts

2006-03-01

Expected to finish

2008-02-01

Last updated by the study team

2017-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• MS subjects who completed Study C-1801 (NCT00027300), C-1802 (NCT00030966), or C-1803 (NCT00097760) and completed a Dosing Suspension Safety Evaluation (neurological examination and magnetic resonance imaging [MRI] scan)
• Considered by the investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy (PML) based on medical history, physical examination, or laboratory testing (results from the Dosing Suspension Safety Evaluation from Study C-1808 [NCT000276172] may be used)
• Other protocol-defined inclusion criteria may apply

You may not qualify if…

• Considered by the investigator to be immunocompromised, based on medical history, physical examination, or laboratory testing (results from the Dosing Suspension Safety Evaluation from Study C-1808 may be used), or due to prior immunosuppressive treatment
• History of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies
• Other protocol-defined exclusion criteria may apply

Where it is running

• Research Site — Phoenix, Arizona, United States
• Research Site — Scottsdale, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Berkeley, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Redwood City, California, United States
• Research Site — Sacramento, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Maitland, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Pompano Beach, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Arlington, Illinois, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Northbrook, Illinois, United States
• Research Site — Des Moines, Iowa, United States
• Research Site — Kansas City, Kansas, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Worcester, Massachusetts, United States
• Research Site — East Lansing, Michigan, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.