Multiple Sclerosis, Relapsing-Remitting
Conditions
Interventions
Experimental intervention 1:
alemtuzumab: 12 mg per day administered through IV, once a day for 5 consecutive days at Month 0 and 12 mg per day administered through IV, once a day for 3 consecutive d
Sponsors
Genzyme Corporation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 - 55 years old 2. Diagnosis of MS and MRI scan demonstrating white matter lesions attributable to MS 3. Onset of MS symptoms within 10 years 4. EDSS score 0.0 to 5.0 5. Greater than or equal to 2 MS attacks within 24 months, with greater than or equal to 1 attack within 12 months 6. Greater than or equal to 1 MS attack (relapse) during treatment with a beta interferon therapy or glatiramer acetate after being on that therapy for at least 6 months within 10 years.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with alemtuzumab 2. Previous treatment with any investigational drug (i.e. medication that is not approved at any dose or for any indication) 3. Treatment with natalizumab, methotrexate, azothioprine or cyclosporine in the past 6 months 4. Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab or any other immunosuppressive or cytotoxic therapy (other than steroid treatment) 5. Any progressive form of MS 6. Any progressive form of MS 7. Any disability acquired from trauma or another illness that could interfere with evaluation of disability due to MS 8. Major systemic disease that cannot be treated or adequately controlled by therapy 9. Active infection or high risk for infection 10. Autoimmune disorder (other than MS) 11. Impaired hepatic or renal function 12. History of malignancy, except basal skin cell carcinoma 13. 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 14. Of childbearing potential with a positive serum pregnancy test, pregnant, or lactating 15. Current participation in another clinical study or previous participation in CAMMS323 16. Previous hypersensitivity reaction to any immunoglobulin product 17. Known allergy or intolerance to interferon beta, human albumin, or mannitol 18. Intolerance of pulsed corticosteroids, especially a history of steroid psychosis 19. Inability to self-administer subcutaneous (SC) injections or receive SC injections from caregiver 20. Inability to undergo MRI with gadolinium administration 21. Unwilling to use a reliable and acceptable contraceptive method throughout the study period (fertile patients only).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Time to Sustained Accumulation of Disability (SAD) [Time Frame: 2 years] - Relapse Rate [Time Frame: 2 years] (Rater-blinding of efficacy outcomes) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion of patients who are relapse free at Year 2 [Time Frame: 2 years] - Change from baseline in EDSS [Time Frame: 2 years] - Acquisition of disability as measured by change from baseline in MSFC [Time Frame: 2 years] - Percent change from baseline in MRI-T2 hyperintense lesion volume at Year 2 [Time Frame: 2 years] (Rater-blinding of efficacy outcomes) | — |
Contacts
Public ContactGenzyme Europe B.V.
Genzyme Europe BV Gooimeer 10
Outcome results
None listed