SurfSubQ - A Prospective Longitudinal Multicenter Observational Study to Investigate Neurofilament Light Chain Levels and Patient Satisfaction After Subcutaneous Ocrelizumab Administration in Persons With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 842
- 试验地点
- 140
- 主要终点
- Number of Participants Their Level of by Satisfaction With Ocrelizumab SC After 12 Months Assessed Using TASQ-SC
研究概览
简要总结
The main purpose of the study is to evaluate participant satisfaction after administration of ocrelizumab subcutaneously (SC) after 12 months using the therapy administration satisfaction questionnaire subcutaneous (TASQ-SC).
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 MS
- •RMS and PPMS participants diagnosed according to the McDonald criteria of 2017 or revised McDonald criteria 2024
- •First treatment during the course of MS therapy with ocrelizumab SC according to the local prescribing information, regardless of the reason for starting treatment with ocrelizumab
排除标准
- •Participation in interventional studies investigating DMTs for MS
- •Prior or simultaneous participation in CONFIDENCE or MoOzaRt (ISRCTN55332718) non interventional study (NIS) at the same study site
- •Prior treatment with rituximab (MabThera®) or ublituximab (Briumvi®)
- •Severe psychiatric disability
- •Pregnant women
研究组 & 干预措施
Ocrelizumab
Participants who are receiving ocrelizumab, SC injection, for the first time as part of their routine MS therapy at physician's discretion in accordance with local clinical practice and/or labeling will be observed for treatment satisfaction with SC injection for up to 12 months.
干预措施: Ocrelizumab (Drug)
结局指标
主要结局
Number of Participants Their Level of by Satisfaction With Ocrelizumab SC After 12 Months Assessed Using TASQ-SC
时间窗: Month 12
TASQ-SC is a 12-item, participant-reported questionnaire measuring the impact of treatment administration on five domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction. Each of the domain/scale scores is scored on a scale of 1-100, where higher scores indicate higher overall satisfaction with the therapy.
Number of Participants by Their Level of Satisfaction With Ocrelizumab SC After 12 Months Assessed Using TASQ-SC
时间窗: Month 12
TASQ-SC is a 12-item, participant-reported questionnaire measuring the impact of treatment administration on five domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction. Each of the domain/scale scores is scored on a scale of 1-100, where higher scores indicate higher overall satisfaction with the therapy.
次要结局
- Number of Participants by Their Level of Satisfaction With Ocrelizumab SC After the First Injection and After 6 Months Assessed Using TASQ-SC(Baseline, Month 6)
- Change From Baseline in NfL Protein Levels in Serum(Month 6, Month 12)
- Concentration of NfL Protein Levels in Serum(Baseline, Month 6, Month 12)
- Correlation Between NfL Protein Levels in Serum With MS Relapse(Up to Month 12)
- Correlation Between NfL Protein Levels in Serum With Expanded Disability Status Scale (EDSS)(Up to Month 12)
- Correlation Between NfL Protein Levels in Serum With Previous MS Disease Modifying Therapy (DMT)(Up to Month 12)
- Correlation Between NfL Protein Levels in Serum With NfL Confounder - Serum Creatinine(Up to Month 12)
- Correlation Between NfL Protein Levels in Serum With NfL Confounder - Co-morbidities(Up to Month 12)
- Correlation Between NfL Protein Levels in Serum With NfL Confounder - Age(Up to Month 12)
- Correlation Between NfL Protein Levels in Serum With NfL Confounder - Body Mass Index [BMI](Up to Month 12)
- Correlation Between NfL Protein Levels in Serum With Magnetic Resonance Imaging (MRI) Lesion Count(Up to Month 12)
- Correlation Between NfL Protein Levels in Serum With Glial Fibrillary Acidic Protein (GFAP) Levels(Up to Month 12)
- Correlation Between NfL Protein Levels in Serum With No Evidence of Disease Activity-3 (NEDA-3)(Up to Month 12)
- Change From Baseline in Participant Satisfaction With Ocrelizumab SC Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM) 1.4(Month 6, Month 12)
- Number of Participants by Their Level of Satisfaction With Ocrelizumab SC Assessed by Physician Survey(Baseline, Month 6, Month 12)
- Annualized Relapse Rate(Month 12)
- Percentage of Participants With Progression Independent of Relapse Activity (PIRA)(Up to Month 12)
- Number of Participants With Non-serious Adverse Events (nsAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs)(Up to Month 12)
- Change From Baseline in NfL Protein Levels in Serum(Baseline, Month 6, Month 12)
- Change From Baseline in Participant Satisfaction With Ocrelizumab SC Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM) 1.4(Baseline, Month 6, Month 12)