A Single-Center, Prospective Cohort Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of infection (including UTI and other active acute, opportunistic and/or chronic infection)
研究概览
简要总结
The purpose of this study is to evaluate the safety of ublituximab use in the older MS adult population, as measured by incidence of infection rate
详细描述
This study is being done to see how safe and effective ublituximab is when given to older adult patients for their RMS. Since RMS patients over age 55 were excluded from previous clinical studies that studied the safety and efficacy of ublituximab, this study is designed to better understand how well this drug is tolerated in RMS patients between the ages of 55-80 years.
Primary endpoints include:
- Incidence of infection rate from Baseline to Month 24/EOS (including UTI and other active acute, opportunistic and/or chronic infection)
- Incidence of TEAS/SAEs from Baseline to Month 24 with consideration to nature, severity, and occurrence rate of AEs
Approximately 20 participants are expected to be enrolled. Participation in this study will last approximately 24 months and will include approximately 6 study visits to the study center.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Aged 55-80 years old
- •Diagnosis of RMS according to the 2017 Revised McDonald criteria
- •Anticipated to begin treatment with or newly treated with ublituximab (within 6 months prior to study entry) according to the local label
排除标准
- •Active participation in an interventional clinical trial for MS
- •Received initial dose of ublituximab more than 6 months prior to study entry
- •History of life-threatening infusion reaction on any anti-CD20 therapy
- •Evidence of clinically significant chronic or ongoing active viral, bacterial, or fungal infectious disease requiring long term systemic treatment, or any history of recurrent infection within 6-12 months prior to initiation of ublituximab
结局指标
主要结局
Incidence of infection (including UTI and other active acute, opportunistic and/or chronic infection)
时间窗: From Baseline to Month 24/End of Study
Incidence of infection rate from Baseline to Month 24/End of Study
Incidence of treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs)
时间窗: From Baseline to Month 24/End of Study
Incidence of TEAEs/SAEs from Baseline to Month 24/End of Study
次要结局
- Total number of new and/or enlarging T2 lesions on all available brain MRI scans(From Baseline to Month 24/End of Study)
- Functional Assessment (Expanded Disability Status Scale (EDSS))(From Baseline to Month 24/End of Study)
- Multiple Sclerosis Impact Scale (MSIS-29)(From Baseline to Month 24/End of Study)
- Absolute lymphocyte count (ALC)(From Baseline to Month 24/End of Study)
- Immunoglobulin levels(From Baseline to Month 24/End of Study)
- Functional Assessment (Timed 25-Foot Walk Test (T25-FW))(From Baseline to Month 24/End of Study)