ACTRN12606000306516尚未招募2 期
Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects with Relapsing Remitting Multiple Sclerosis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Biogen Idec
- 入组人数
- 264
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 55 Years（—）
- 性别
- All
入选标准
- •Diagnosed with relapsing-remitting multiple sclerosis (according to McDonald criteria #1-4, Section 22), with a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, and who either have experienced at least 1 relapse within the 12 months prior to randomization with a cranial MRI demonstrating lesion(s) consistent with MS or show evidence of Gd-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization.
排除标准
- •1.Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS2. History of malignancy; however, subjects with a history of excised or treated basal cell carcinoma or fewer than 3 squamous sell carcinomas are eligible to participate in this study.3. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.4. History of abnormal laboratory results that, in the opinion of the investigator, are indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurologic (other than MS), and/or other major disease that would preclude administration of DAC HYP.5. History of human immunodeficiency virus (HIV) or other immunodeficient conditions.6. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization.7. An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization.8. Positive for hepatitis C virus (HCV) antibody and/or positive for hepatitis B surface antigen (HBsAg) at Screening.9. Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before Screening.10. Exposure to varicella zoster virus within 21 days before Screening.11. Any of the following abnormal blood tests at Screening:i.Hemoglobin < or = 9.0 g/dLii.Platelets < or = 100 x 109/Liii.Lymphocytes < or = 1.0 x 109/Liv.Neutrophils < or = 1.5 x 109/L12. Any previous treatment with DAC HYP or Zenapax®.13. Any of the following types of live virus vaccine from 4 weeks before randomization: measles/mumps/rubella vaccine, varicella zoster virus vaccine, oral polio vaccine, and nasal influenza vaccine. Use of these vaccines, however, by other members of the subject’s household does not affect the eligibility of patients to enroll or continue in the study.14. Infection (viral, fungal, bacterial) requiring hospitalization or intravenous (IV) antibiotics within 8 weeks before randomization.15. Elective surgery performed from 2 weeks prior to randomization or scheduled through the end of the study.16. Prior treatment with the any of the following:· total lymphoid irradiation· cladribine· mitoxantrone· T-cell or T-cell receptor vaccination· any therapeutic monoclonal antibody, except natalizumab or rituximab17. Prior treatment with cyclophosphamide or rituximab within 1 year prior to randomization.18. Prior treatment with any of the following medications or procedures within the 6 months prior to randomization:· natalizumab· cyclosporine· azathioprine· methotrexate· intravenous immunoglobulin (IVIg)· plasmapheresis or cytapheresis19. Prior treatment with any of the following within the 3 months prior to randomization:·SC or oral glatiramer acetate·IFN-alpha·IFN-beta (subjects who are positive for neutralizing antibodies to IFN beta may receive IFN-beta treatment up to 2 weeks prior to randomization)20. Treatment with any of the following medications within the 30 days prior to randomization:·IV corticosteroid treatment·oral corticosteroid treatment·4-aminopyridine or related products21. Female subjects considering becoming pregnant while in the study.22. Female subjects who are currently pregnant or breastfeeding.23. Previous participation in this study.24. Subjects, for whom MRI is contraindicated, i.e., have pacemakers or other contraindicated implanted meta
研究者
相似试验
进行中（未招募）
不适用
Multicentre, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects with Relapsing-Remitting Multiple Sclerosis. - SELECTMultiple sclerosis (MS)MedDRA version: 8.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosisEUCTR2006-001161-42-HUBiogen Idec Ltd.600
进行中（未招募）
不适用
Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - Not applicableMultiple sclerosis (MS)EUCTR2006-001161-42-SEBiogen Idec Ltd.232
进行中（未招募）
不适用
Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - SELECTMultiple sclerosis (MS)MedDRA version: 8.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosisEUCTR2006-001161-42-CZBiogen Idec Ltd.600
进行中（未招募）
不适用
A study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis.EUCTR2006-001161-42-DEBiogen Idec Ltd.600
进行中（未招募）
1 期
Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - SELECTMultiple sclerosis (MS)MedDRA version: 8.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosisEUCTR2006-001161-42-GBBiogen Idec Ltd600