A Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High Dose Alemtuzumab and High-Dose Subcutaneous Interferon Beta-1a (Rebif®) in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis
The aims of treatment for multiple sclerosis (MS) therapy are to prevent the progression of
disease and accumulation of long-term disability. The hypothesis underlying this study is
that aggressive treatment of inflammation in the brain early in the course of MS will
protect the patient from disease progression and accumulating disability.
This protocol compares two different doses of alemtuzumab and Rebif® to evaluate the kind of
side effects that patients experience and to evaluate wich drug is better at:
- Slowing the sustained accumulation of disability in patients with MS
- Reducing the frequency of relapses that patients with MS experience);
- Reducing the effects of MS on the brain, as assessed by magnetic resonance imaging
(MRI)
Patients who receive alemtuzumab during the initial 36-month treatment period may be
eligible for additional alemtuzumab retreatment on either a fixed or an as-needed schedule
to evaluate:
- How long the effects of prior alemtuzumab treatment last;
- If additional treatments with alemtuzumab continue to reduce the effects of MS; and
- What kind of side effects patients experience once patients begin taking alemtuzumab
again
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Sustained Accumulation of Disability (SAD), Confirmed Through 6 Months
3 years
No
Medical Monitor
Study Director
Genzyme
United States: Food and Drug Administration
CAMMS223
NCT00050778
December 2002
June 2013
Name | Location |
---|---|
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
University of Maryland | Baltimore, Maryland 21201 |
Clinical Trials, Inc | Little Rock, Arkansas 72205 |
East Bay Region Associates in Neurology | Berkeley, California 94705 |
Nerve Pro Research | Irvine, California 92618 |
Neuro-Therapeutics, Inc. | Pasadena, California 91105 |
Multiple Sclerosis Service | Walnut Creek, California 94596 |
Colorado Neurology & Headache Center | Denver, Colorado 80218 |
Neurological Services of Orlando | Orlando, Florida 32806 |
Neurological Associates | Sunrise, Florida 33351 |
Tampa Neurology Associates | Tampa, Florida 33609 |
Sleep Medicine and Neurology | Columbus, Georgia 31901 |
Medical Research & Health Education Foundation | Columbus, Georgia 31909 |
Consultants in Neurology, Ltd. | Northbrook, Illinois 60062 |
Fort Wayne Neurological Center | Fort Wayne, Indiana 46805 |
Associates in Neurology, P.S.C. | Lexington, Kentucky 40503 |
Wayne State University, The School of Medicine, Dept of Neurology | Detroit, Michigan 48201 |
Michigan Institute for Neurological Disorders | Farmington, Michigan 48334 |
Michigan Medical P.C. , West Michigan MS Clinic | Grand Rapids, Michigan 49525 |
Mayo Clinic and Foundation | Rochester, Minnesota 55905 |
Nevada Neurological Consultants | Henderson, Nevada 89052 |
University Hospital Stony Brook | Stony Brook, New York 11794 |
Triad Neurology Services | Winston-Salem, North Carolina 27103 |
Neurological Associates of Tulsa, Inc. | Tulsa, Oklahoma 74136 |
Neurosciences Research, MS Center | Allentown, Pennsylvania 18103 |
Knoxville Neurology Associates, Baptist Hospital | Knoxville, Tennessee 37920 |
Central Texas Neurology Consultants | Austin, Texas 78681 |
Baylor College of Medicine, Dept. of Neurology | Houston, Texas |
Dallas Neurological Associates | Richardson, Texas 75080 |
Neurology Center of San Antonio | San Antonio, Texas 78212 |
Integra Clinical Research, LLC | San Antonio, Texas 78229 |