Plegridy™ (Peginterferon β-1a) Real World Effectiveness and Safety Observational Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 1,208
- 试验地点
- 2
- 主要终点
- Safety as measured by the incidence rate of SAEs
研究概览
简要总结
The primary objectives of the study are to determine the incidence of serious adverse events (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical practice and to assess the overall long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice. The secondary objectives of this study in this study population are to describe Plegridy prescription and utilization adherence patterns in routine clinical practice; to assess the specific long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice; to monitor the safety and tolerability of Plegridy in routine clinical practice by assessing the incidence of adverse events (AEs) of flu-like symptoms (FLS), injection site reactions (ISRs), and AEs (including laboratory abnormalities) leading to treatment discontinuation; to assess the effect of FLS on participant-reported effectiveness of, and satisfaction with, prophylactic management using a FLS-Visual Analog Scale (FLS-VAS); to evaluate the change in health-related quality of life (HRQoL), FLS, FLS-VAS, healthcare resource consumption, and treatment adherence over time.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with MS who is newly, or is currently, prescribed Plegridy according to local label including patients who participated in Study 105MS302 (NCT01332019) or Study 105MS303 (NCT01939002).
- •Patient willing and able to complete patient-reported outcomes (PRO) with minimal assistance.
排除标准
- •Concurrent enrollment in any clinical trial of an investigational product. Participation in non-interventional study can be allowed as long as this participation does not interfere with this protocol or is likely to affect the subject's ability to comply with the protocol.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
peginterferon beta-1a
Plegridy will not be supplied for this study. The study will collect data in an observational manner from participants who are prescribed Plegridy by physicians, according to the approved label in the respective country.
干预措施: peginterferon beta-1a (Drug)
结局指标
主要结局
Safety as measured by the incidence rate of SAEs
时间窗: Up to 5 years
Safety as measured by the incidence proportion of SAEs
时间窗: Up to 5 years
Clinical NEDA as measured by the proportion of participants with no disability progression
时间窗: Up to 5 years
Clinical no evidence of disease activity (NEDA) as measured by the proportion of participants with no relapses
时间窗: Up to 5 years
次要结局
- Relapse activity as measured by annualized relapse rate (ARR)(Up to 5 years)
- Prescription and utilization patterns as measured by the primary reason for discontinuation of Plegridy(Up to 5 years)
- Relapse activity as measured by time to first relapse(Up to 5 years)
- Relapse activity as measured by the proportion of participants with relapse(Up to 5 years)
- Relapse activity as measured by the distribution of the number of relapses(Up to 5 years)
- Changes in FLS assessment and FLS-VAS over time(Baseline to 5 years)
- Treatment adherence as measured by changes in adherence over time as reported in the treatment adherence questionnaires(Baseline to 5 years)
- Prescription and utilization patterns as measured by prescribed dosing frequency(Up to 5 years)
- Disability progression as measured by the proportion of participants with sustained progression for at least six months(Up to 5 years)
- Prescription and utilization patterns as measured by duration of Plegridy use(Up to 5 years)
- Disability progression as measured by the time to sustained disability progression for at least six months(Up to 5 years)
- Impact of the severity of FLS on the ability to successfully manage symptoms via prophylaxis as measured by the participant-reported FLS-VAS(Up to 5 years)
- Changes in EuroQoL EQ-5D, 3-level (EQ-5D-3L) score over time(Baseline to 5 years)
- Frequency of MS-related and non-MS-related physician visits, specialists' visits, use of physiotherapy, hospitalizations and lengths of stay, and emergency room/department visits(Up to 5 years)
- Incidence proportion of non-serious AEs leading to treatment discontinuation(Up to 5 years)
- Incidence rate of non-serious AEs leading to treatment discontinuation(Up to 5 years)