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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

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

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Trial Information

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.

Inclusion Criteria:

- Diagnosis of MS and cranial MRI scan demonstrating white matter lesions attributable
to MS within 5 years

- Onset of MS symptoms within 5 years

- EDSS score 0.0 to 3.0

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

Exclusion Criteria:

- Received prior therapy for MS other than corticosteroids

- Exposure to immunosuppressive or immunomodulatory agents other than systemic
corticosteroid treatment

- Received treatment with a monoclonal antibody for any reason

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

- Has 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 lactating

- Current participation in another clinical study

- 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:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2007

Completion Date:

May 2011

Related Keywords:

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



University of Kansas Medical CenterKansas City, Kansas  66160-7353
University of Rochester Medical CenterRochester, New York  14642
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
Wayne State UniversityDetroit, Michigan  48202
Louisiana State University Health Sciences CenterShreveport, Louisiana  71130
Neurological AssociatesSunrise, Florida  33351
Consultants in Neurology, Ltd.Northbrook, Illinois  60062
Fort Wayne Neurological CenterFort Wayne, Indiana  46805
Central Texas Neurology ConsultantsAustin, Texas  78681
Neurology Center of San AntonioSan Antonio, Texas  78212
Mayo Clinic ArizonaScottsdale, Arizona  85259
Advanced Neurosciences InstituteFranklin, Tennessee  37064
North Central Neurology Associates, P.C.Cullman, Alabama  
Barrow Neurology Clinics at St. Joseph's Hospital and Medical CenterPhoenix, Arizona  
Northwest NeuroSpecialists, PLLCTucson, Arizona  
Advanced Neurosciences Research LLCFort Collins, Colorado  
Axiom Clinical Research of FloridaTampa, Florida  
Eastern Idaho Neurological AssociatesIdaho Falls, Idaho  
MidAmerica Neuroscience InstituteLenexa, Kansas  
Associates in Neurology, PSCLexington, Kentucky  
University of Louisville, Kentucky Neuroscience ResearchLouisville, Kentucky  
UMass Memorial Health CareWorcester, Massachusetts  
University of Michigan Department of NeurologyAnn Arbor, Michigan  
Empire Neurology PCLatham, New York  
NYU Hospital of Joint DiseasesNew 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 CenterColumbus, Ohio  
Oak Clinic for Multiple SclerosisUniontown, Ohio  
MS Center of OklahomaOklahoma City, Oklahoma  
Lehigh Valley Hospital, Neuroscience and Pain ResearchAllentown, Pennsylvania  
Sibyl Wray, MD, Neurology, PCKnoxville, Tennessee  
Baylor College of Medicine, Maxine Mesinger MS ClinicHouston, Texas  
Integra Clinical Research, L.L.C.San Antonio, Texas