CTRI/2014/04/004551已完成3 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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,841
- 试验地点
- 6
- 主要终点
- The primary objective of the study is to assess the safety and tolerability of long-term treatment with DAC HYP monotherapy in subjects who completed Study 205MS301.
研究概览
简要总结
This study will provide subjects who complete Phase 3 Study 205MS301 with the opportunity to receive open-label DAC HYP monotherapy prior to local product marketing approval for evaluation of long-term safety, efficacy, and immunogenicity of DAC HYP in subjects with RRMS.
No new patients will be recruited (screened or enrolled) for the study. Patients on-going in trial 205MS301 study will be rolled over to this extention phase of the study. CTRI registration number of 205MS301 study is: REFCTRI/2010/000254
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •To be eligible to participate in this study, candidates must meet the following eligibility criteria at the 205MS303 Baseline Visit or at the timepoint specified in the individual eligibility criterion listed:
- •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.
- •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).
- •Note: Subjects who are not able to enroll into 205MS303 at the time of their Week 144/End of Study Visit may be eligible to enroll into 205MS303 at a later time if they are still participating in the 6-month follow-up period of 205MS301 at the time of expected rollover into 205MS
- •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.
排除标准
- •Candidates will be excluded from study entry if any of the following exclusion criteria exist at the Study 205MS303 Baseline Visit or at the timepoint specified in the individual criterion listed (Note: Day 1 is the day of the first dose in Study 205MS303): Medical History
- •Any subject who permanently discontinued study treatment in Study 205MS301 prior to the end of the study treatment period, or had an Early Termination visit in Study 205MS
- •Note: Subjects for whom dosing was temporarily suspended in Study 205MS301 are not excluded from participation in this extension study if the criteria for resuming DAC HYP treatment under the Study 205MS301 protocol have been met at the time of enrollment into Study 205MS
- •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 205MS
- •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) from the most recently available test in Study 205MS301, as determined by the Investigator.
- •Laboratory findings mandating discontinuation of study treatment as defined in Protocol 205MS301 are exclusionary.
- •Any of the following abnormal blood tests within the 7 days prior to Day 1: alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase (GGT) 3 the upper limit of normal (ULN) Note: Subjects ending 205MS301 on a treatment suspension may not enroll into 205MS303 until ALT/SGPT and AST/SGOT are 2 ULN.
- •total bilirubin 2 ULN (subjects with an established diagnosis of Gilberts syndrome are excluded if total bilirubin is 2.5 ULN) Note: Subjects ending 205MS301 on a treatment suspension may not enroll into 205MS303 until total bilirubin 1 ULN (subjects with an established diagnosis of Gilberts syndrome may not enroll into 205MS303 until total bilirubin is 1.5 ULN).
- •Other medical reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment.
- •Treatment History
- •Treatment with any prohibited concomitant medication during Study 205MS
- •Miscellaneous
- •Female subjects who are currently pregnant or breastfeeding, or considering becoming pregnant while in the study.
- •Previous participation in Study 205MS
- •History of drug or alcohol abuse (as defined by the Investigator) at any time after the start of Study 205MS
- •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.
结局指标
主要结局
The primary objective of the study is to assess the safety and tolerability of long-term treatment with DAC HYP monotherapy in subjects who completed Study 205MS301.
时间窗: 144 weeks
次要结局
- 1. To assess the long-term immunogenicity of DAC HYP administered by PFS(2. To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and patient-reported impact of MS, following long-term treatment with DAC HYP)
研究者
研究点 (6)
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