ISRCTN21534255已完成3 期
A phase 3 randomised, rater-blinded study comparing two annual cycles of intravenous alemtuzumab to three-times weekly subcutaneous interferon beta-1a (Rebif®) in treatment-naïve patients with relapsing-remitting multiple sclerosis
Genzyme Corporation (USA)0 个研究点目标入组 581 人开始时间: 2009年3月11日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 581
研究概览
简要总结
- 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23122652
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Amended as of 22/06/2009:
- •Point 6 below has been removed from the inclusion criteria.
- •Initial information at time of registration:
- •1. Males and females, aged 18 - 50 years
- •2. Diagnosis of multiple sclerosis (MS) and cranial magnetic resonance imaging (MRI) scan demonstrating white matter lesions attributable to MS within 5 years
- •3. Onset of MS symptoms within 5 years of screening
- •4. Expanded Disability Status Scale (EDSS) score 0.0 to 3.0
- •5. Greater than or equal to 2 MS attacks within 24 months, with greater than or equal to 1 attack within 12 months
- •6. Neurologically stable for the 30 days prior to the date the Informed Consent Form is signed
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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