MRI and Clinical Disease Activity in Patients Treated Long Term With Natalizumab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 277
- 试验地点
- 3
- 主要终点
- Change over time in the number of participants free of new or enlarging FLAIR lesions
研究概览
简要总结
The primary objective of the study is to retrospectively investigate the proportion of participants free of new or enlarging fluid-attenuated inversion recovery (FLAIR) lesions over time in approximately 300 Relapsing-Remitting Multiple Sclerosis (RRMS) participants with regular MRI follow-up, who have received natalizumab ≥24 month from two different observational cohorts: 1) approximately 230 participants from the Czech Republic; and 2) approximately 70 participants from Belgium. The secondary objectives of this study are as follows: Brain volume change by various measures; Changes in the number and volume of magnetic resonance imaging (MRI) lesions; No evidence of disease activity (NEDA) with and without brain volume change.
详细描述
Natalizumab will not be provided to participants by Biogen as a part of this study. Participants will remain on natalizumab therapy as prescribed by their physician.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RRMS.
- •Continuous treatment with natalizumab of ≥24 months. In case of a treatment interruption from natalizumab ≥60 days after a total treatment period of ≥24 months, only the treatment prior to the interruption will be analyzed. Any data after this treatment interruption (even if the patient restarts natalizumab) will not be analyzed/collected.
- •≥1 MRI scan of sufficient quality for reliable measurement.
- •Baseline MRI scan ≤6 month prior to natalizumab treatment acquired.
- •≥1 MRI scan of sufficient quality for reliable measurement taken while on natalizumab treatment for ≥6 months.
- •EDSS ≤ 6.
排除标准
- •Anti-natalizumab antibody detection.
- •Prior treatment with alemtuzumab.
- •Prior treatment with mitoxantrone within 12 months of the first infusion of natalizumab.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Czech Republic
Approximately 230 participants with RRMS receiving commercial natalizumab in Czech Republic
干预措施: natalizumab (Drug)
Belgium
Approximately 70 participants with RRMS receiving commercial natalizumab in Belgium
干预措施: natalizumab (Drug)
结局指标
主要结局
Change over time in the number of participants free of new or enlarging FLAIR lesions
时间窗: Treatment years 3 and 4
Lesions that are ≥5 mm per scan (slice thickness 3 mm) as assessed by semiautomatic lesion count (by the Icometrix algorithm).
次要结局
- Annualized brain volume change rate as assessed by % change in brain parenchymal fraction [BPF](Post long term treatment with natalizumab (>2 years) through Year 4)
- Annualized brain volume change rate as assessed by white matter [WM] and gray matter [GM] atrophy)(Post long term treatment with natalizumab (>2 years) through Year 4)
- Cumulative number of new ≥6-month confirmed T1-hypointense lesions(Post long term treatment with natalizumab (>2 years) through Year 4)
- Number of participants with brain volume loss ≤0.2% and ≤0.4%(Post long term treatment with natalizumab (>2 years) through Year 4)
- Annualized brain volume change rate as assessed by percent brain volume change [PBVC](Post long term treatment with natalizumab (>2 years) through Year 4)
- Annualized T1-hypointense and FLAIR lesion volume change(Post long term treatment with natalizumab (>2 years) through Year 4)
- Cumulative percent change in T1-hypointense and FLAIR lesion volume(Post long term treatment with natalizumab (>2 years) through Year 4)
- Cumulative number of ≥6-month-confirmed T1-hypointense lesions arising from new on- treatment Gadolinium (Gd+)-enhancing lesions(Post long term treatment with natalizumab (>2 years) through Year 4)
- Number of total participants and 4-year completers with NEDA as measured by clinical measures(Post long term treatment with natalizumab (>2 years) through Year 4)
- Number of total participants and 4-year completers with NEDA as measured by radiological measures(Post long term treatment with natalizumab (>2 years) through Year 4)