NL-OMON27332已完成不适用
A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif) in Patients with Relapsing-Remitting Multiple Sclerosis Who Have Relapsed on Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 700
研究概览
简要总结
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.
- 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
- 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.
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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).
研究者
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