EUCTR2010-021978-11-IT进行中（未招募）不适用
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis - 101MS326
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 856
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. 2. Be between the ages of 18 and 58, inclusive, at the time of informed consent. 3. Onset of SPMS at least 2 years prior to enrollment. SPMS is defined as relapsing-remitting disease followed by progression of disability independent of or not explained by MS relapses (Lublin, Reingold, 1996) ) for at least 2 years. 4. Have EDSS score of 3.0 to 6.5, inclusive. 5. Have an MS Severity Score (MSSS) of 4 or higher. 6. Have documented confirmed evidence of disease progression independent of clinical relapses over the 1 year prior to enrollment as defined in the Study Reference Guide. 7. Subjects must have completed those baseline assessments associated with components of the primary endpoint (EDSS, T25FW, 9HPT) prior to randomization (Day 0). 8. Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last infusion.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 856
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Have a diagnosis of RRMS or primary progressive MS as defined by the revised McDonald Committee criteria (Polman et al 2005). 2. Had a recent clinical relapse (within 3 months) prior to randomization. 3. Have a T25FW test of >30 seconds during the screening period. 4. Any value below the lower limit of normal for blood levels of leukocytes, lymphocytes, or neutrophils. 5. Considered by the Investigator to be immunocompromised based on medical history, physical examination, laboratory testing, or any other testing required by local guidelines, or due to prior immunosuppressive or immunomodulating treatment. 6. Subjects for whom MRI is contraindicated (i.e., have pacemakers or other contraindicated implanted metal devices, are allergic to gadolinium, or have claustrophobia that cannot be medically managed). 7. History of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, and renal, or other major disease that would preclude participation in a clinical study. 8. History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).9. Known history of or positive test result for Human Immunodeficiency Virus (HIV). 10. Positive test result for hepatitis C virus (test for hepatitis C virus antibody [HCV Ab]) or hepatitis B virus (test for hepatitis B surfaceantigen [HBsAg] and/or hepatitis B core antibody [HBcAb]). 11. History of transplantation or any anti-rejection therapy. 12. Presence of any infectious disease (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to screening. 13. History of PML or other opportunistic infections including active tuberculosis. Treatment History 14. Any prior treatment with cell-depleting therapies, including total lymphoid irradiation, cladribine, rituximab, alemtuzumab, or bone marrow ablation. 15. Any prior treatment with natalizumab. 16. Treatment with mitoxantrone, cyclophosphamide, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, T cell or T cell receptor vaccination, fingolimod, daclizumab, or cytapheresis within 6 months prior to randomization. 17. Treatment with IV or oral corticosteroids, intravenous immunoglobulin (IVIg), or plasmapheresis for treatment of MS within the 3 months prior to randomization. 18. Treatment with glatiramer acetate or any interferon beta preparations within 4 weeks prior to randomization. 19. Treatment with 4-aminopyridine within 30 days prior to randomization, unless a stable dose has been maintained for at least 30 days prior to randomization and will be continued for the course of this study. Miscellaneous 20. Female subjects considering becoming pregnant while in the study. 21. Female subjects of childbearing potential who have a positive pregnancy test at either the Screening Visit or Week 0. 22. Female subjects who are pregnant or currently breastfeeding. 23. History of drug or alcohol abuse, in the opinion of the Investigator, within 2 years prior to entry.
研究者
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