CTRI/2011/12/002229已完成3 期
A Dose-Frequency Blinded, Multicenter, Extension Study to determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biogen Idec
- 入组人数
- 1,500
- 试验地点
- 19
- 主要终点
- Primary Outcome Measures:
研究概览
简要总结
This study is A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis. The purpose of this Extension Study is to determine the long-term safety, tolerability, and MS outcomes of BIIB017 in subjects completing Study 105MS301 (ADVANCE).
Subjects will administer 125 mcg BIIB017 subcutaneously (SC) at 2 dose frequencies: every 2 weeks or every 4 weeks. In this extension study, subjects will continue to administer BIIB017 at the same dose regimen they were following during their participation in the second treatment year of Study 105MS301.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulationsSubjects who participated in Study 105MS301 who completed the study treatment and visit schedule through Week 96 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 dose of study treatment.
排除标准
- •Subjects exceeding more than 6 weeks since completion of the Week 96 visit of Study 105MS301 Subjects with any significant change in medical history, including laboratory tests or a current clinically significant condition that in the opinion of the Investigator would have excluded the subject from participation in Study 105MS
- •The Investigator must re-review the subject�s medical fitness for participation and consider any factors that would preclude treatment including � Presence of any clinically significant as determined by the Investigator cardiac endocrinologic hematologic hepatic immunologic metabolic urologic pulmonary neurologic dermatologic psychiatric renal or other major disease that would preclude participation in a clinical study Presence 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 Clinically significant laboratory abnormalities hematology and blood chemistry on the most recently available test of Study 105MS301 as determined by the Investigator.
- •Laboratory findings mandating discontinuation of study treatment as defined in protocol 105MS301 are exclusionary.
- •Female subjects who are currently pregnant as reflected by a positive pregnancy test at the Week 96 Visit of Study 105MS301 Baseline Visit who are currently breastfeeding or who are considering becoming pregnant while in the study
- •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 subjects ability to comply with the protocol.
- •Other unspecified reasons that in the opinion of the Investigator or Biogen Idec make the subject unsuitable for enrollment.
结局指标
主要结局
Primary Outcome Measures:
时间窗: 2 Years
The incidence of adverse events and lab abnormalities as a measure of the long-term safety and tolerability of BIIB017
时间窗: 2 Years
次要结局
- •MS outcomes assessed using the annualized relapse rate (ARR)(•MRI outcomes assessed using the number and volume of brain lesions [ Time Frame: 2 years ])
研究者
研究点 (19)
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