Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS.

Key facts

Study ID

NCT00027300

Run by

Biogen

People needed

900

Starts

2001-11-01

Expected to finish

2005-01-01

Last updated by the study team

2017-01-09

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of MS, as defined by McDonald et al., criteria # 1-4 (McDonald et al., 2001)
• Between the ages of 18 and 50, inclusive.
• Baseline EDSS score between 0.0 and 5.0, inclusive.
• Have experienced at least one relapse within the 12 months prior to randomization.
• Cranial MRI scan demonstrating lesion(s) consistent with MS.
• Have given written informed consent to participate in the study.

You may not qualify if…

• Primary progressive, secondary progressive, or progressive relapsing MS.
• MS relapse has occurred,in the opinion of the investigator, within 50 days prior to randomization and/or the subject has not stabilized from a previous relapse.
• A clinically significant infectious illness within 30 days prior to randomization.
• History of, or abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal and/or other major disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent for 116 weeks.
• History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
• Unable to perform the Timed 25-foot Walk, 9HPT, and PASAT 3.
• Abnormal blood tests performed at the Screening Visit.

Where it is running

• East Bay Region Associates in Neurology — Berkeley, California, United States
• UC Davis School of Medicine, Department of Neurology — Davis, California, United States
• Yale University School of Medicine, Department of Neurology — New Haven, Connecticut, United States
• University of Miami School of Medicine, Department of Neurology — Miami, Florida, United States
• University of Kansas Medical Center, Department of Neurology — Kansas City, Kansas, United States
• Michigan Institute for Neurological Disorders — Farmington Hills, Michigan, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Gimbel MS Center — Teaneck, New Jersey, United States
• CMRRC — Albuquerque, New Mexico, United States
• Oregon Health Sciences University, Department of Neurology — Portland, Oregon, United States
• Lehigh Valley Hospital, Neurosciences Research — Allentown, Pennsylvania, United States
• Texas Neurology — Dallas, Texas, United States
• University of Washington MS Research Center — Seattle, Washington, United States
• Algemeen Ziekenhuis St. Jan — Bruges, Belgium
• LUC- University Centre — Diepenbeek, Belgium
• National MS Centrum — Melsbroek, Belgium
• Vancouver Hospital and Health Sciences Center UBC Pavilion, MS Clinical Research Group — Vancouver, British Columbia, Canada
• Health Services Centre — Winnipeg, Manitoba, Canada
• Kingston General Hospital, Neurology — Kingston, Ontario, Canada
• University Hospital — London, Ontario, Canada
• Sunnybrook and Women's College and Health Science Centre — Toronto, Ontario, Canada
• University of Toronto, MS Clinic, St. Michael's Hospital — Toronto, Ontario, Canada
• CHVO Hull Hospital — Québec, Quebec, Canada
• MS Research Unit, Center for Clinical Research — Halifax, Canada
• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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