A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple Sclerosis
Every patient will receive active treatment; there is no placebo. Patients who qualify will
be randomly assigned to treatment with either alemtuzumab or Rebif® at a 2:1 ratio (ie, 2
given 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 CAMMS03409 (NCT 00930553) an extension study for safety and
efficacy assessments. Patients who receive Rebif® and complete 2 years on study may be
eligible to receive alemtuzumab on 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
United States: Food and Drug Administration
CAMMS323
NCT00530348
September 2007
May 2011
Name | Location |
---|---|
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
University of Rochester Medical Center | Rochester, New York 14642 |
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
Wayne State University | Detroit, Michigan 48202 |
Louisiana State University Health Sciences Center | Shreveport, Louisiana 71130 |
Neurological Associates | Sunrise, Florida 33351 |
Consultants in Neurology, Ltd. | Northbrook, Illinois 60062 |
Fort Wayne Neurological Center | Fort Wayne, Indiana 46805 |
Central Texas Neurology Consultants | Austin, Texas 78681 |
Neurology Center of San Antonio | San Antonio, Texas 78212 |
Mayo Clinic Arizona | Scottsdale, Arizona 85259 |
Advanced Neurosciences Institute | Franklin, Tennessee 37064 |
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 |
Carolinas Medical Center (CMC)/Neurosciences & Spine Institute (NSSI) | Charlotte, North Carolina |
The Ohio State University Medical Center, Multiple Sclerosis Center | Columbus, Ohio |
Oak Clinic for Multiple Sclerosis | Uniontown, Ohio |
MS Center of Oklahoma | Oklahoma City, Oklahoma |
Lehigh Valley Hospital, Neuroscience and Pain Research | Allentown, Pennsylvania |
Sibyl Wray, MD, Neurology, PC | Knoxville, Tennessee |
Baylor College of Medicine, Maxine Mesinger MS Clinic | Houston, Texas |
Integra Clinical Research, L.L.C. | San Antonio, Texas |