ACTRN12608000435381进行中（未招募）3 期
A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif (registered trademark)) on Relapse Rate and Time to Sustained Accumulation of Disability in Treatment-Naive Patients with Relapsing-Remitting Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 581
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •1. Diagnosis of MS and cranial MRI scan demonstrating white matter lesions attributable to MS within 5 years
- •2. Onset of MS symptoms within 5 years
- •3. EDSS score 0.0 to 3.0
- •4. Greater than or equal to 2 MS attacks within 24 months, with greater than or equal to 1 attack within 12 months
排除标准
- •1. Received prior therapy for MS other than corticosteroids
- •2. Exposure to immunosuppressive or immunomodulatory agents other than systemic corticosteroid treatment
- •3. Received treatment with a monoclonal antibody for any reason
- •4. Previous treatment with any investigational drug (i.e. medication that is not approved at any dose for any indication)
- •5. Has 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
- •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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