An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab
Alemtuzumab treatment will either be on a fixed schedule of two treatment cycles a year
apart for patients who received Rebif® in one of the prior Genzyme-sponsored studies of
alemtuzumab or on an as needed schedule (e.g. due to documented evidence of resumed MS
activity) for patients who have already completed a fixed schedule of treatment with
alemtuzumab in one of the prior Genzyme-sponsored studies. There is no comparison treatment
in this study. All patients will be required to return to their study site every 3 months
for neurologic and other assessments. In addition, safety-related laboratory tests and
surveys will be performed at least monthly. Participation in the extension study will last
48 months from enrollment, but some patients may need additional safety follow-up via a
separate mechanism beyond the 48 months.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Time to Sustained Accumulation of Disability (SAD)
Prior study baseline through Extension Month 48
No
Medical Monitor
Study Director
Genzyme Coorporation
United States: Food and Drug Administration
CAMMS03409
NCT00930553
August 2009
February 2016
Name | Location |
---|---|
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Stanford University Medical Center | Stanford, California 94305-5408 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
University of Chicago Medical Center | Chicago, Illinois 60637 |
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
The University Of North Carolina At Chapel Hill | Chapel Hill, North Carolina 27599-7235 |
Neuro-Therapeutics, Inc. | Pasadena, California 91105 |
Neurological Associates | Sunrise, Florida 33351 |
Fort Wayne Neurological Center | Fort Wayne, Indiana 46805 |
Associates in Neurology, P.S.C. | Lexington, Kentucky 40503 |
Central Texas Neurology Consultants | Austin, Texas 78681 |
Neurology Center of San Antonio | San Antonio, Texas 78212 |
Lehigh Valley Hospital Neurosciences and Pain Research | Allentown, Pennsylvania 18103 |
UMass Memorial Medical Center | Worcester, Massachusetts 01655 |
Advanced Neurosciences Institute | Franklin, Tennessee 37064 |
University of Michigan Medical School | Ann Arbor, Michigan 48106 |
North Central Neurology Associates, P.C. | Cullman, Alabama |
Northwest NeuroSpecialists, PLLC | Tucson, Arizona |
Axiom Clinical Research of Florida | Tampa, Florida |
MidAmerica Neuroscience Institute | Lenexa, Kansas |
Oak Clinic for Multiple Sclerosis | Uniontown, Ohio |
Baylor College of Medicine, Maxine Mesinger MS Clinic | Houston, Texas |
Hope Research Institute | Phoenix, Arizona |
University of Florida Neuroscience Institute | Jacksonville, Florida |
Neurology Associates, P.A. | Maitland, Florida |
Negroski, Stein, Sutherland and Hanes Neurology | Sarasota, Florida |
Consultants in Neurology, Ltd | Northbrook, Illinois |
Iowa Health Physicians | Des Moines, Iowa |
MS Center at Holy Name Hospital | Teaneck, New Jersey |
Integra Clinical Research | San Antonio, Texas |
MS Center of Greater Washington | Vienna, Virginia |
East Bay Physicians Medical Group/ Sutter East Bay Medical Foundation | Berkeley, California |
Emory University Department of Neurology | Atlanta, Georgia |
Northern Michigan Neurology | Traverse City, Michigan |
Wake Forest University Health Science Department of Neurology | Winston-Salem, North Carolina |
Neurology Clinic PC | Cordova, Tennessee |
St. Joseph's Hospital and Medical Center Barrow Neurology Clinics - Barrow Neurological Institute | Phoenix, Arizona |
Mayo Clinic Arizona (Scottsdale) | Scottsdale, Arizona |
Neurology Center North Orange County | La Habra, California |
University of Southern California Keck School of Medicine/University of Southern California LAC & USC Medical Center | Los Angeles, California |
University of Colorado Health Science Center - Aurora | Aurora, Colorado |
Advanced Neurology of Colorado | Ft. Collins, Colorado |
Yale MS Research Center | New Haven, Connecticut |
The George Washington University Medical Faculty Associates | Washington, District of Columbia |
University of South Florida College of Medicine | Tampa, Florida |
Shepherd Center Multiple Sclerosis Institute | Atlanta, Georgia |
Indiana University Multiple Sclerosis Center | Indianapolis, Indiana |
Ruan Neurology Clinic and Clinical Research Center, Mercy Medical Center | Des Moines, Iowa |
University of Kansas Medical Center, Department of Neurology | Kansas City, Kansas |
Kentucky Neuroscience Research | Louisville, Kentucky |
University of Maryland, Maryland Center for MS | Baltimore, Maryland |
The MS Center at St. Elizabeth's | Boston, Massachusetts |
Michigan Neurology Association | Clinton Twp, Michigan |
Wayne State University, The School of Medicine, Department of Neurology | Detroit, Michigan |
Spectrum Health Medical Group, Neurology/Michigan Medical P.C., West Michigan MS Clinic | Grand Rapids, Michigan |
Saint Luke's Brain & Stroke Institute | Kansas City, Missouri |
Renown Institute for Neurosciences | Reno, Nevada |
University of New Mexico, Dept. of Neurology | Albuquerque, New Mexico |
Empire Neurology P.C. | Latham, New York |
Winthrop University Hospital Multiple Sclerosis Treatment Center | Mineola, New York |
MS Care Center at NYUMC and HJD | New York, New York |
The Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai | New York, New York |
South Shore Neurologic Associates, P.C. | Patchogue, New York |
Rochester Multiple Sclerosis Center | Rochester, New York |
SUNY Upstate Medical University, Department of Neurology | Syracuse, New York |
OMRF Multiple Sclerosis Center of Excellence | Oklahoma City, Oklahoma |
Rhode Island Hospital MS Center - The Neurology Foundation, Inc | Providence, Rhode Island |
Hope Neurology | Knoxville, Tennessee |
Swedish Medical MS Center | Seattle, Washington |