EUCTR2012-003176-39-GB进行中（未招募）1 期
A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,501
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
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. Must be a subject currently participating in Study 205MS301 who has completed either the Week 144 Visit or the End of Study Visit (Week 96) OR subject currently participating in Study 205MS203 or Study 205MS302.
- •3. Women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1600
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Medical History
- •1. Any subject who permanently discontinued study treatment in Study 205MS301, Study 205MS203, or Study 205MS302 prior to the end of the study treatment period, or had an Early Termination visit in those studies OR any subject who has completed all the safety follow-up visits after Week 144 of Study 205MS303 per the original protocol.
- •Note: Subjects for whom dosing was temporarily suspended in Study 205MS301,Study 205MS203, or Study 205MS302 are not excluded from participation in this extension study if the criteria for resuming DAC HYP treatment under the parent study protocol have been met at the time of enrollment into Study 205MS303.
- •2. Any significant change in the subject’s medical history that would preclude administration of DAC HYP, including laboratory tests or a current clinically significant condition that, in the opinion of the Investigator, would have excluded the subject’s participation in Study 205MS301,Study 205MS203, or Study 205MS302. The Investigator must re review the subject’s medical fitness for participation and consider any factors that would preclude treatment in Study 205MS303, including:
- •History of any significant cardiac, endocrine, hematological, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurological (other than MS), and/or other major disease (e.g., malignancy) that would preclude administration of DAC HYP.
- •Clinically significant laboratory abnormalities (hematology and blood chemistry) as determined by the Investigator. Laboratory findings mandating discontinuation of study treatment as defined in parent study protocol are exclusionary.
- •3. Other medical reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment.
- •Treatment History
- •4. Treatment with any prohibited concomitant medication during the parent study.
- •Note: Subjects who start an approved, open-label IFN ß preparation after completion of dosing in Study 205MS301 are not excluded, but IFN ß treatment must be discontinued before the first dose of DAC HYP in Study 205MS303 is given.
- •Miscellaneous
- •5. Female subjects who are currently pregnant or breastfeeding, or considering becoming pregnant while in the study.
- •6. History of drug or alcohol abuse (as defined by the Investigator) at any time after the start of Study 205MS303 or any of the parent studies.
- •7. Unwillingness or inability to comply with the requirements of the protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject’s ability to comply with the protocol.
研究者
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