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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

Phase 3
18 Years
55 Years
Not Enrolling
Multiple Sclerosis, Relapsing-Remitting

Thank you

Trial Information

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.

Inclusion Criteria:

- Diagnosis of MS and MRI scan demonstrating white matter lesions attributable to MS

- Onset of MS symptoms within 10 years

- EDSS score 0.0 to 5.0

- ≥2 MS attacks within 24 months, with ≥1 attack within 12 months

- ≥1 MS attack (relapse)during treatment with a beta interferon therapy or glatiramer
acetate after having been on that therapy for at least 6 months within 10 years

Exclusion Criteria:

- Previous treatment with alemtuzumab

- Previous treatment with any investigational drug (i.e. a medication that is not
approved at any dose or for any indication)

- Treatment with natalizumab, methotrexate, azothioprine or cyclosporine in the past 6

- Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab, or any
other immunosuppressive, or cytotoxic therapy (other than steroid treatment)

- Any progressive form of MS

- Any disability acquired from trauma or another illness that could interfere with
evaluation of disability due to MS

- Major systemic disease that cannot be treated or adequately controlled by therapy

- Active infection or high risk for infection

- Autoimmune disorder (other than MS)

- Impaired hepatic or renal function

- History of malignancy, except basal skin cell carcinoma

- Medical, psychiatric, cognitive, or other conditions that compromise the patient's
ability to understand the patient information, to give informed consent, to comply
with the trial protocol, or to complete the study

- Known bleeding disorder

- Of childbearing potential with a positive serum pregnancy test, pregnant, or

- Current participation in another clinical study or previous participation in CAMMS323

- Previous hypersensitivity reaction to any immunoglobulin product

- Known allergy or intolerance to interferon beta, human albumin, or mannitol

- Intolerance of pulsed corticosteroids, especially a history of steroid psychosis

- Inability to self-administer subcutaneous (SC) injections or receive SC injections
from caregiver

- Inability to undergo MRI with gadolinium administration

- Unwilling to use a reliable and acceptable contraceptive method throughout the study
period (fertile patients only)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Time to Sustained Accumulation of Disability (SAD)

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme Coorporation


United States: Food and Drug Administration

Study ID:




Start Date:

October 2007

Completion Date:

September 2011

Related Keywords:

  • Multiple Sclerosis, Relapsing-Remitting
  • Multiple Sclerosis
  • Multiple Sclerosis
  • Sclerosis
  • Multiple Sclerosis, Relapsing-Remitting



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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