A Multicentre Non-interventional Study to Assess the Real-world Effectiveness of Ocrelizumab in Patients With Relapsing or Primary Progressive Multiple Sclerosis - The MuSicalE STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,710
- 试验地点
- 318
- 主要终点
- Changes in the overall SymptoMScreen score in participants with RMS
研究概览
简要总结
This is a multicentre non-interventional study aimed at evaluating the real-world effectiveness and safety of ocrelizumab treatment in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS), who have been prescribed ocrelizumab as per routine practice. This study will use a comprehensive combination of participant reported outcomes and conventional multiple sclerosis (MS) endpoints that measure clinical domains commonly affected by MS (e.g. fatigue, hand function, gait, cognition), and their impact on employment, activities of daily living, quality of life and healthcare resource utilization. The incidence, type, and pattern of serious adverse events (SAEs), and of adverse events (AEs) leading to treatment discontinuation will also be determined.
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
- •Must have a definite diagnosis of RMS or PPMS and in whom a decision to initiate ocrelizumab has been taken as part of routine clinical practice
- •Must be prescribed ocrelizumab in line with the SmPC
- •Must have provided signed informed consent
- •Must be able and willing to complete the PROs as per clinical practice
排除标准
- •Previously treated with ocrelizumab (including phase II, phase III and phase IIIB clinical trials, local trials and investigator initiated study (IIS) as well as a pre-approval access or compassionate use programmes or local registries that are not compatible with the MuSicalE study design)
- •Not receiving ocrelizumab in line with the SmPC
研究组 & 干预措施
Ocrelizumab
Participants with relapsing or primary progressive MS receiving ocrelizumab under routine clinical care.
干预措施: Ocrelizumab (Drug)
结局指标
主要结局
Changes in the overall SymptoMScreen score in participants with RMS
时间窗: 4 years
SymptoMScreen is a battery of 7-point Likert scales for 12 distinct domains: mobility, dexterity, body pain, sensation, bladder function, fatigue, vision, dizziness, cognition, depression, and anxiety. Composite scores (range min: 0, max: 72) Subscores for each functional domain (range: 0-not affected at all; 6: total limitation/I'm unable to do most daily activities)
Changes in the overall SymptoMScreen score in participants with PPMS
时间窗: 4 years
SymptoMScreen is a battery of 7-point Likert scales for 12 distinct domains: mobility, dexterity, body pain, sensation, bladder function, fatigue, vision, dizziness, cognition, depression, and anxiety. Composite scores (range min: 0, max: 72) Subscores for each functional domain (range: 0-not affected at all; 6: total limitation/I'm unable to do most daily activities)
次要结局
- Time to treatment discontinuation due to adverse events with ocrelizumab in participants with PPMS(4 years)
- Percentage of RMS Participants with Adverse Events(4 years)
- Percentage of PPMS participants with Adverse Events(4 years)
- Time to treatment discontinuation due to adverse events with ocrelizumab in participants with RMS(4 years)
- Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in RMS participants(4 years)
- Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in PPMS participants(4 years)
- Change in the score of ABILHAND - 56 scale in RMS participants(4 years)
- Change in the score of ABILHAND - 56 scale in PPMS participants(4 years)
- Change in the score of MSWS - 12 scale in RMS participants(4 years)
- Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in RMS participant(4 years)
- Change in the score of MSWS - 12 scale in PPMS participants(4 years)
- Changes in proportion of patients employed/non-employed, number of inpatient days, hospital admissions, medication use and associated costs over the course of the study, captured by the MS-COI in RMS Participants(4 years)
- Changes in proportion of patients employed/non-employed, number of inpatient days, hospital admissions, medication use and associated costs over the course of the study, captured by the MS-COI in PPMS Participants(4 years)
- Disease progression in participants with PPMS as measured by Expanded Disability Status Scale (EDSS) over time(4 years)
- Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in PPMS participants(4 years)
- Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in RMS participants(4 years)
- Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in PPMS participants(4 years)
- Frequency of relapses over time in RMS patients(4 years)
- Disease progression in participants with RMS as measured by Expanded Disability Status Scale (EDSS) over time(4 years)