A Prospective Longitudinal Multicenter, Multi-Country, Observational Study Assessing Patient Satisfaction After Subcutaneous Ocrelizumab Administration in Persons With Relapsing-Remitting Multiple Sclerosis (SONATA-MS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,800
- 主要终点
- Proportion of Satisfied/Very Satisfied Responses on the Treatment Administration Satisfaction Questionnaire (TASQ) - Satisfaction Item Score at Month 12
研究概览
简要总结
The main purpose of the study is to assess patient-reported satisfaction with subcutaneous (s.c.) ocrelizumab administration in participants with relapsing-remitting multiple sclerosis (RRMS) who are treatment-naive, switching from intravenous (i.v.) ocrelizumab to s.c. ocrelizumab, or switching from a prior disease-modifying therapy (DMT) to s.c. ocrelizumab.
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
- •Diagnosis of RRMS according to the revised McDonald criteria (2017 or 2024 revisions).
- •Initiation of ocrelizumab s.c in accordance with routine clinical practice and local prescribing information.
- •The decision to initiate ocrelizumab s.c. has been made by the treating physician prior to and independently of study participation.
- •Willingness to complete the patient-reported outcome questionnaire TASQ, where applicable.
排除标准
- •Participation in any clinical study involving disease modifying therapies for multiple sclerosis during the study period or at the time of enrollment.
- •Prior treatment with rituximab.
- •Contraindications to ocrelizumab as per the local prescribing information.
- •Severe psychiatric or cognitive impairment that, in the opinion of the treating physician, would preclude informed consent, reliable participation in the study, or completion of patient-reported outcomes.
- •Any condition which, in the opinion of the treating physician, would interfere with participation in the study or the interpretation of study results.
- •For participants participating in a Market Research and Patient Support Program (MAP), inclusion is permitted only when a cross-reference to the unique MAP patient identifier is available.
研究组 & 干预措施
Cohort 2
Participants who were receiving ocrelizumab i.v. and then switched to ocrelizumab s.c., representing a change in route of administration as outlined in the protocol will be observed for 12 months to characterize participant satisfaction following initiation of ocrelizumab s.c.
干预措施: Ocrelizumab (Drug)
Cohort 1
Treatment-naive participants initiating ocrelizumab s.c., as outlined in the protocol will be observed for 12 months to characterize participant satisfaction following initiation of ocrelizumab s.c.
干预措施: Ocrelizumab (Drug)
Cohort 3
Treatment experienced participants who were receiving prior DMTs and then switched to ocrelizumab s.c., as outlined in the protocol will be observed for 12 months to characterize participant satisfaction following initiation of ocrelizumab s.c.
干预措施: Ocrelizumab (Drug)
结局指标
主要结局
Proportion of Satisfied/Very Satisfied Responses on the Treatment Administration Satisfaction Questionnaire (TASQ) - Satisfaction Item Score at Month 12
时间窗: At Month 12
次要结局
- Proportion of Convenient / Very Convenient Responses on the TASQ Convenience Item Score at Month 12(At Month 12)
- Change From Baseline in Serum Neurofilament Light Chain (NfL) at Months 6 and 12(Baseline, Months 6 and 12)
- Annualized Relapse Rate (ARR) From Baseline to Month 12(Baseline to Month 12)
- Proportion of Relapse-Free Participants From Baseline Through Month 12 Following Ocrelizumab s.c. Initiation(Baseline to Month 12)
- Proportion of Participants Persistent on Treatment From Baseline Through Month 12(Baseline to Month 12)
- Incidence, Severity and Outcomes of Adverse Events (AEs)(Up to 2.6 years)
- Duration of AEs(Up to 2.6 years)