None listed
Conditions
Brief summary
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 (Registered trademark for 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 MRI. Patients will have monthly laboratory tests and comprehensive testing every 3 months. 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 (registered trademark) at a 2:1 ratio (ie, 2 given 12 mg alemtuzumab for every 1 given Rebif (registered trademark)). Patients will not be able to guess which treatment will be randomly assigned to them. Alemtuzumab will be administered in two annual cycles, once at the beginning of the study and again 1 year later. Rebif (registered trademark) 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, all patients who receive alemtuzumab will be followed in an extension study for safety and efficacy assessments. Patients who receive Rebif (registered trademark) and complete 2 years on study may be eligible to receive alemtuzumab in an extension study.
Interventions
alemtuzumab: 12 mg per day administered through intravenous therapy (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 days at Month 12
alemtuzumab: 24 mg per day administered through IV, once a day for 5 consecutive days at Month 0 and 24 mg per day administered through IV, once a day for 3 consecutive days at Month 12 (Note: The 24 mg alemtuzumab dose is closed to enrollment.)
Sponsors
Genzyme Corporation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of MS (Multiple Sclerosis) and MRI scan demonstrating white matter lesions attributable to MS 2. Onset of MS symptoms within 10 years 3. EDSS score 0.0 to 5.0 4. Greater than or equal to 2 MS attacks within 24 months, with greater than or equal to 1 attack within 12 months 5. Greater than or equal to 1 MS attack (relapse) during treatment with a interferon beta therapy or glatiramer acetate after having been on that therapy for at least 6 months within 10 years
Exclusion criteria
1. Previous treatment with alemtuzumab 2. Previous treatment with any investigational drug (i.e. medication that is not approved at any dose 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 disability acquired from trauma or another illness that could interfere with evaluation of disability due to MS 7. Major systemic disease that cannot be treated or adequately controlled by therapy 8. Active infection or high risk for infection 9. Autoimmune disorder (other than MS) 10. Impaired hepatic or renal function 11. History of malignancy, except basal skin cell carcinoma 12. 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 13. Known bleeding disorder 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 anyimmunoglobulin 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)
Outcome results
None listed