Safety and Efficacy of Natalizumab in Combination With Avonex 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 if natalizumab in combination with AVONEX is safe and effective in delaying progression of individuals diagnosed with relapsing remitting Multiple Sclerosis (MS).

Key facts

Study ID

NCT00030966

Run by

Biogen

People needed

1200

Starts

2002-01-01

Expected to finish

2005-12-01

Last updated by the study team

2009-06-18

Who can join

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

You may qualify if…

• Diagnosis of MS as defined by McDonald et al, criteria, # 1- 4
• Between the ages of 18 and 55, inclusive
• Baseline EDSS score between 0.0 and 5.0, inclusive
• Have been treated with Avonex for at least the 12 months prior to randomization
• Have experienced at least one relapse (while on Avonex) within the 12 months prior to randomization.
• Cranial MRI scan demonstrating lesions 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 within 50 days of randomization
• A clinically significant infectious illness within 30 days prior to randomization
• History of, or abnormal lab result, indicative of significant disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent or Avonex 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 at Screening Visit

Where it is running

• Phoenix Neurological Associates, Ltd. — Phoenix, Arizona, United States
• University of Arkansas For Medical Sciences — Little Rock, Arkansas, United States
• University of California - Irvine — Irvine, California, United States
• USC MS Comprehensive Care Center — Los Angeles, California, United States
• Kaiser-Permanente Medical Center — Redwood City, California, United States
• MS Center at UCSF — San Francisco, California, United States
• Healthsouth Rehabilitation Hospital — Colorado Springs, Colorado, United States
• University of Colorado MS Center — Denver, Colorado, United States
• Griffin Hospital — Derby, Connecticut, United States
• Georgetown Univesity Hospital, Research Pharmacy — Washington D.C., District of Columbia, United States
• George Washington University MS Center — Washington D.C., District of Columbia, United States
• North Ridge NeuroScience Center — Fort Lauderdale, Florida, United States
• Maitland Neurology — Maitland, Florida, United States
• University of Miami, Department of Neurology — Miami, Florida, United States
• The Multiple Sclerosis Center of Atlanta — Atlanta, Georgia, United States
• Marietta Neurological Associates — Marietta, Georgia, United States
• Northwestern University, Department of Neurology — Chicago, Illinois, United States
• Rush-Presbyterian St. Luke's Medical Center — Chicago, Illinois, United States
• Alexian Brothers Center for Clinical Research — Elk Grove Village, Illinois, United States
• Loyola Medical Center — Maywood, Illinois, United States
• Consultants in Neurology Northbrook — Northbrook, Illinois, United States
• Springfield Clinic Neuroscience Institute — Springfield, Illinois, United States
• Indiana University Medical Center — Indianapolis, Indiana, United States
• Mercy Hospital Outpatient Pharmacy — Des Moines, Iowa, United States
• University of Alabama-Birmingham, Department of Neurology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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