500 Boylston Street, Boston, MA 02116 617-419-4700
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The purpose of this study is to establish the efficacy and safety of two different doses of
alemtuzumab as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison
with Rebif® (interferon beta-1a). The study will enroll patients who have received an
adequate trial of disease-modifying therapies but continued to relapse while being treated,
and who meet a minimum severity of disease as measured by magnetic resonance imaging (MRI).
Patients will have monthly laboratory tests and comprehensive testing every 3 months.
Ages:18 - 55
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 months - 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 lactating - Current participation in another clinical study or previous participation in CAMMS323 (NCT00530348) - 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)
Sponsor: Genzyme, a Sanofi Company
Phase: Phase 3
Trial ID: NCT00548405
Not Accepting Healthy Volunteers