A Cross-sectional Study to Assess the Effectiveness and Safety of Ofatumumab (Kesimpta®) in Patients With Relapsing Multiple Sclerosis in the Spanish Clinical Practice: the CRONOS-MS Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Reductions in the Annualized relapse rate (ARR)
研究概览
简要总结
This was a non-interventional, cross-sectional, multicentric, and nationwide study, based on primary and secondary data collection.
详细描述
The present study aimed to characterize the use of subcutaneous ofatumumab in a real-world setting. Specifically, the investigation assessed the effectiveness, safety, and treatment adherence associated with subcutaneous ofatumumab in individuals with relapsing forms of multiple sclerosis (RMS) within the Spanish healthcare system.
The study used primary and secondary data collection. Primary data collection included information collected using PRO, clinical-reported outcomes (ClinRO), scales or tests and the interview during the study visit. Secondary data collection included existing data from electronic medical records (EMR) or paper-based medical records, collected as part of the routine follow-up of patients with RMS in the clinical practice.
Baseline was defined as the date of ofatumumab initiation.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years.
- •Written informed consent.
- •Diagnosis of RMS per McDonald Criteria (2017).
- •Ofatumumab treatment in line with the European Kesimpta® summary of product characteristics (SmPC; i.e. adult patients with RMS with active disease defined by clinical or imaging features) during at least 12 months and patients who discontinued ofatumumab after receiving at least one dose with a minimum monitoring of 12 months.
排除标准
- •Currently participating in a clinical trial.
- •Not able/unlikely to complete with all study activities according to investigator's criteria.
- •Have a contraindication for ofatumumab use, according to the SmPC.
结局指标
主要结局
Reductions in the Annualized relapse rate (ARR)
时间窗: 12 months preceding the initiation of ofatumumab, Baseline
ARR, defined as the total number of confirmed relapses that occurred during the observation period divided by the total number of patient-years, with the result standardized to a 1-year period. A relapse is defined as new or recurrent symptoms and objective typical findings of MS with a duration of at least 24 h, in the absence of fever or infection and preceded by a stable or improving neurological state for ≥ 30 days
次要结局
- Reductions in the ARR in naïve vs previously treated patients(12 months preceding the initiation of ofatumumab, Baseline)
- Reductions in the ARR in previously treated with high-efficacy Disease-modifying treatments (DMT) vs previously treated with moderate-efficacy DMT(12 months preceding the initiation of ofatumumab, Baseline)
- Number of days from ofatumumab treatment initiation to first relapse(12 months)
- Proportion of relapse-free patients(12 months)
- Change in EDSS score(Baseline, month 6, month 12)
- Number of participants with radiological disease activity on the cranial MRI(Baseline, month 6, month 12)
- Percentage of participants reporting injection site reactions (ISR)(Baseline, month 6, month 12)
- Percentage of patients with AEs leading to temporal or permanent discontinuation(Up to 12 months)
- Number of pregnancies and pregnancy outcome(Up to 12 months)
- Proportion of participants with non-adherence(Up to 12 months)
- Proportion of patients who discontinue ofatumumab during the observation period(Up to 12 months)
- Scores on the Work Productivity and Activity Impairment (WPAI) questionnaire(Baseline)
- Scores on the SDMT(Baseline)
- Scores on the Modified Fatigue Impact Scale-5 (MFIS-5)(Baseline)
- Scores on the EuroQol-5 dimension (EQ-5D)-5L(Baseline)
- Scores on the Patients' Global Impression of Change (PGIC) scale completed by patients(Baseline)
- Scores on the Clinical Global Impressions (CGI) scale completed by physicians(Baseline)
- Scores on the Treatment Satisfaction Questionnaire for Medication (TSQM-9)(Baseline)