Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing 2 Annual Cycles of IV [Low]- and High-Dose Alemtuzumab to 3x Weekly SC Interferon Beta-1a (Rebif®) in Relapsing-Remitting Multiple Sclerosis Patients Who Have Relapsed on Therapy
Every patient will receive active treatment; there is no placebo. The 24 mg alemtuzumab dose
is closed to enrollment so newly enrolled patients will be randomly assigned to treatment
with either 12 mg alemtuzumab or Rebif® at a 2:1 ratio (ie, 2 given 12 mg or 24 mg
alemtuzumab for every 1 given Rebif®). Alemtuzumab will be administered in two annual
cycles, once at the beginning of the study and again 1 year later. Rebif® will be
self-injected 3 times per week for 2 years. All patients will be required to return to
their study site every 3 months for neurologic assessment. In addition, safety-related
laboratory tests will be performed at least monthly. Participation in this study will end 2
years after the start of treatment for each patient. Additionally, patients who receive
alemtuzumab may be followed in the CAMMS03409 Extension Study (NCT00930553) for safety and
efficacy assessments. Patients who receive Rebif® and complete 2 years on study may be
eligible to receive alemtuzumab in the Extension Study.
Interventional
Allocation: 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)
2 years
No
Medical Monitor
Study Director
Genzyme Coorporation
United States: Food and Drug Administration
CAMMS32400507
NCT00548405
October 2007
September 2011
Name | Location |
---|---|
Stanford University Medical Center | Stanford, California 94305-5408 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Virginia Mason Medical Center | Seattle, Washington 98111 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
University of Rochester Medical Center | Rochester, New York 14642 |
Winthrop University Hospital | Mineola, New York 11501 |
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
Saint Luke's Hospital | Chesterfield, Missouri 63017 |
SUNY Upstate Medical University | Syracuse, New York 13210 |
University of Chicago Medical Center | Chicago, Illinois 60637 |
Wayne State University | Detroit, Michigan 48202 |
Louisiana State University Health Sciences Center | Shreveport, Louisiana 71130 |
Neurological Associates | Sunrise, Florida 33351 |
Fort Wayne Neurological Center | Fort Wayne, Indiana 46805 |
Central Texas Neurology Consultants | Austin, Texas 78681 |
Neurology Center of San Antonio | San Antonio, Texas 78212 |
The Emory Clinic | Atlanta, Georgia 30322 |
University of New Mexico Hospital | Albuquerque, New Mexico |
Mayo Clinic Rochester | Rochester, Minnesota 55905 |
UC Davis Medical Center | Sacramento, California 95817 |
Indiana University Hospital | Indianapolis, Indiana 46202 |
Yale University Multiple Sclerosis Center | New Haven, Connecticut 06510 |
Advanced Neurosciences Institute | Franklin, Tennessee 37064 |
Swedish Neuroscience Institute | Seattle, Washington 98122 |
George Washington University Medical Faculty Associates | Washington, District of Columbia 20037 |
Tupelo Neurology Clinic, Pa | Tupelo, Mississippi 38801 |
University of Nevada School of Medicine | Reno, Nevada 89503 |
North Central Neurology Associates, P.C. | Cullman, Alabama |
Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center | Phoenix, Arizona |
Northwest NeuroSpecialists, PLLC | Tucson, Arizona |
Advanced Neurosciences Research LLC | Fort Collins, Colorado |
Axiom Clinical Research of Florida | Tampa, Florida |
Eastern Idaho Neurological Associates | Idaho Falls, Idaho |
MidAmerica Neuroscience Institute | Lenexa, Kansas |
Associates in Neurology, PSC | Lexington, Kentucky |
University of Louisville, Kentucky Neuroscience Research | Louisville, Kentucky |
UMass Memorial Health Care | Worcester, Massachusetts |
University of Michigan Department of Neurology | Ann Arbor, Michigan |
Empire Neurology PC | Latham, New York |
NYU Hospital of Joint Diseases | New York, New York |
Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C. | Patchogue, New York |
The Ohio State University Medical Center, Multiple Sclerosis Center | Columbus, Ohio |
Oak Clinic for Multiple Sclerosis | Uniontown, Ohio |
Lehigh Valley Hospital, Neuroscience and Pain Research | Allentown, Pennsylvania |
Hope Research Institute | Phoenix, Arizona |
Mayo Clinic Arizona, Department of Neurology | Scottsdale, Arizona |
East Bay Physicians Medical Group/Sutter East Bay Medical Foundation | Berkeley, California |
Neurology Center of North Orange County | La Habra, California |
Department of Neurology, Keck School of Medicine, University of Southern California | Los Angeles, California |
Neuro-Therapeutics, Inc | Pasadena, California |
University of Colorado Hospital Anschutz Outpatient Pavilioin | Aurora, Colorado |
Colorado Neurological Consultants | Denver, Colorado |
University of Florida Neuroscience Institute | Jacksonville, Florida |
Neurology Associates, P.A. | Maitland, Florida |
Negroski, Stein, Sutherland and Hanes Neurology | Sarasota, Florida |
University of South Florida Medical Clinics | Tampa, Florida |
Shephard Center Inc | Atlanta, Georgia |
Consultants in Neurology, Ltd | Northbrook, Illinois |
Josephson Wallack Munshower Neurology P.C. | Indianapolis, Indiana |
Iowa Health Physicians | Des Moines, Iowa |
Ruan Neurology Clinic and Research Center | Des Moines, Iowa |
Caritas St. Elizabeth's Hospital Medical Center | Boston, Massachusetts |
Partners Multiple Sclerosis Center/Brigham and Women's Hospital | Brookline, Massachusetts |
Springfield Neurology Associates, LLC | Springfield, Massachusetts |
Michigan Medical, PC | Grand Rapids, Michigan |
Michigan Neurology Associates, P.C. | St. Clair Shores, Michigan |
North Michigan Neurology | Traverse City, Michigan |
The MS Center for Innovations in Care | St. Louis, Missouri |
Montana Neurobehavioral Specialists | Missoula, Montana |
Renown Institute for Neurosciences / Renown regional Medical Center | Reno, Nevada |
MS Center at Holy Name Hospital | Teaneck, New Jersey |
Mount Sinai School of Medicine, Corinne Goldsmith Dickinson Center for Multiple Sclerosis | New York, New York |
University of North Caroline-Chapel Hill, Department of Neurology | Chapel Hill, North Carolina |
Wake Forest University Health Science | Winston-Salem, North Carolina |
The Cleveland Clinic Mellen Center | Cleveland, Ohio |
Neurology Specialists, Inc. | Dayton, Ohio |
MS Center of Oklahoma, Mercy Health Center | Oklahoma City, Oklahoma |
North Shore Clinical Associates | Erie, Pennsylvania |
Kaufmann Medical Building, Department of Neurology | Pittsburgh, Pennsylvania |
Rhode Island Hospital and The Neurology Foundation, Inc | Providence, Rhode Island |
Neurology Clinic, P.C. | Cordova, Tennessee |
Sibyl Wray, MD Neurology, PC | Knoxville, Tennessee |
Clinical Center for Multiple Sclerosis | Dallas, Texas |
Integra Clinical Research | San Antonio, Texas |
MS Center of Greater Washington | Vienna, Virginia |
Rockwood Clinical Research Center | Spokane, Washington |