A double blind, multi center, extension study to evaluate the safety and efficacy of DAC HYP in subjects with Multiple Sclerosis who have completed treatment in study 205MS201 (SELECT).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biogen Idec
- 入组人数
- 600
- 试验地点
- 5
- 主要终点
- 1. An assessment of safety and immunogenicity of extended treatment with DAC HYP when administered to MS subjects who have completed 52 weeks of active therapy with DAC HYP in Study 205MS201. 2. An assessment of safety and immunogenicity during a 6-month washout period from DAC HYP. 3. An assessment of safety and immunogenicity during re-initiation of therapy with DAC HYP after a 6-month washout period. 4. An assessment of safety and immunogenicity of DAC HYP when administered to MS subjects who previously received placebo during study 205MS201
研究概览
简要总结
The rationale of this study is to extend DAC HYP therapy from study 205MS201 in order to evaluate the long term safety, efficacy and immunogenicity of DAC HYP in multiple sclerosis.Globally as of date, 221 patients have been rolled into this extension study out of the 621 patients who had been randomized in 205MS201 (SELECT) study. The first patient in India is expected to be Jan 2011. Approximately 20 patients are expected to be recruited in India. The first patient is expected to be enrolled in the study in India is by Jan 2011. The enrollment period in India will be from Jan 2011 to April 2012.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 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 (PHI) in accordance with national and local subject privacy regulations.
- •Must be a subject from Study 205MS201 for at least 52 weeks and must have been compliant with the 205MS201 protocol in the opinion of the Investigator.
- •All male subjects and female subjects 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.
- •For further details of contraceptive requirements for this study.
排除标准
- •Subjects with any significant change in their medical status from Study 205MS201that would preclude administration of DAC HYP including laboratory results or acurrent clinically-significant condition that, in the opinion of the Investigator, wouldhave excluded the subject?s participation in Study 205MS
- •The Investigator mustre-review the subject?s medical fitness for participation and must consider anydiseases that would preclude treatment with DAC HYP.
- •Any subject who has permanently discontinued study treatment in Study 205MS201except subjects who were unblinded during evaluation of an adverse event (AE) andfound to be on placebo.
- •Planned ongoing treatment with any approved or experimental treatment for MSexcept for the protocol-allowed use of concomitant IFN-beta.
- •Current enrollment in any investigational drug study other than 205MS201.
- •Unwillingness or inability to comply with the requirements of the protocol, includingthe presence of any condition (physical, mental, or social) that is likely to affect thesubject's ability to comply with the protocol.
- •Other unspecified reasons that, in the opinion of the Investigator or the Biogen IdecMedical Director, make the subject unsuitable for enrollment.
结局指标
主要结局
1. An assessment of safety and immunogenicity of extended treatment with DAC HYP when administered to MS subjects who have completed 52 weeks of active therapy with DAC HYP in Study 205MS201. 2. An assessment of safety and immunogenicity during a 6-month washout period from DAC HYP. 3. An assessment of safety and immunogenicity during re-initiation of therapy with DAC HYP after a 6-month washout period. 4. An assessment of safety and immunogenicity of DAC HYP when administered to MS subjects who previously received placebo during study 205MS201
时间窗: After the patient completes week 52 in study 205MS201
次要结局
- to assess the durability of the effect of DAC HYP on MS disease activity as measured by brain magnetic resonance imaging (MRI) scans and clinical MS relapses.(After the patient completes week 52 in study 205MS201.)