Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, Study Two
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Registration Number
- NL-OMON27332
- Lead Sponsor
- Genzyme Corporation
- Brief Summary
Coles AJ, Cox A, Le Page E, et al. The window of therapeutic opportunity in multiple sclerosis: evidence from monoclonal antibody therapy. J Neurol. 2006;253(1);98-108. <br> <br><br> - Fox E, Sullivan H, Gazda S. Open label, single-arm, Phase II study of alemtuzumab in patients with active relapsing-remitting multiple sclerosis who have failed licensed beta-interferon therapies. Poster presentation P06.07 at the 59th Annual Meeting of the American Academy of Neurology (AAN) on 03 May 2007 <br><br> - CAMMS223 Trial Investigators; Coles AJ, Compston DA, Selmaj KW, Lake SL, Moran S, Margolin DH, Norris K, Tandon PK. Alemtuzumab vs. interferon beta-1a in early multiple sclerosis. N Engl J Med. 2008 Oct 23;359(17):1786-801.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 700
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.
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method