Optical Coherence Tomography (OCT) in a Multicenter, Randomized,Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- To determine the proportion of patients with RNFL decrease of 5 microns or more from baseline to month 12 in the BIIB-17 vs. placebo arms.
研究概览
简要总结
This research sub-study is being completed as a part of the Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis (Protocol #: NA_00028117). This substudy is being done to understand the efficacy of BIIB017 by measuring the nerve fiber thickness in the eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
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.
- •A participant in the ADVANCE study aged 18 to 55 years old, inclusive, at the time of informed consent
排除标准
- •As per the ADVANCE main study
- •History of intraocular surgery, retinal disease, glaucoma, or diabetes
- •Refractive errors of more than ±6.0 diopters
- •Inability to tolerate OCT procedure
研究组 & 干预措施
Placebo for 48 weeks, BIIB017 for 48 weeks
Placebo every 2 weeks for 48 weeks followed by 125 mcg BIIB017 SC every 2 or 4 weeks for 48 weeks.
干预措施: BIIB017 (Drug)
BIIB017 every 2 weeks for 96 weeks
125 mcg BIIB017 SC every 2 weeks for 96 weeks.
干预措施: BIIB017 (Drug)
BIIB017 every 4 weeks for 96 weeks
125 mcg BIIB017 SC every 4 weeks for 96 weeks.
干预措施: BIIB017 (Drug)
结局指标
主要结局
To determine the proportion of patients with RNFL decrease of 5 microns or more from baseline to month 12 in the BIIB-17 vs. placebo arms.
时间窗: 1 year
To determine the proportion of patients with RNFL decrease of 5 microns or more from baseline to month 24 in the BIIB-17 vs. placebo arms.
时间窗: 2 years
次要结局
- Analysis of proportion of patients with a decrease of >10 percent of baseline value in any RNFL quadrant from baseline to month 12 in the BIIB-17 vs. placebo arms.(baseline and 1 year)
- Analysis of decrease between baseline scans and 3 month scan (to examine for pseudoatrophy) in this study population.(baseline and 3 months)
- Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (12 months) in this study population.(3 months and 1 year)
- Analysis of macular volume decreases from baseline or 3 months to follow up scans at 12 months in this study population.(baseline and 1 year)
- Analysis of retinal nuclear layer decreases from baseline or 3 months to follow up scan at 12 months in this study population.(baseline and 1 year)
- Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis.(2 years)
- Analysis of proportion of patients with a decrease of >10 percent of baseline value in any RNFL quadrant from baseline to month 24 in the BIIB-17 vs. placebo arms.(baseline and 2 years)
- Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (24 months) in this study population.(3 months and 2 years)
- Analysis of macular volume decreases from baseline or 3 months to follow up scans at 24 months in this study population.(baseline and 2 years)
- Analysis of retinal nuclear layer decreases from baseline or 3 months to follow up scan at 24 months in this study population.(baseline and 2 years)