Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 174
- 试验地点
- 11
- 主要终点
- Proportion of patients demonstrating NEDA-3
研究概览
简要总结
This non-interventional study will compare the effect of Ofatumumab treatment between patients that began Ofatumumab within the 3 years after Multiple Sclerosis diagnosis and patients that began Ofatumumab with more than 3 years of Multiple Sclerosis diagnosis in a real-world setting in Portugal.
详细描述
This is a 2 cohort, multi-center, observational study carried out in Portugal that aims to describe the effectiveness of Ofatumumab in a setting of routine medical care. Primary data will be collected from Multiple Sclerosis patients who initiate Ofatumumab early and later in their disease (cohorts 1 and 2, respectively).
Data will be collected during 3 visits distributed over a maximum period of 24 months. Exceptionally, if the patient shows Expanded Disability Status Scale (EDSS) worsening in visit 2 or 3 (12 and 24 months after Ofatumumab initiation, respectively), there will be an additional visit 6±1 months after visit 2 or 3 for EDSS confirmation.
The study includes patients that have initiated Ofatumumab up to 12 months prior inclusion in the study OR Patients that are initiating Ofatumumab at the moment of study inclusion.
Patients in both cohorts will have to be treated with Ofatumumab for at least two years to compare No Evidence of Disease Activity (NEDA)-3 at 12 to 24 months, respectively.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To participate in the study, all the following inclusion criteria must be met:
- •Patients aged 18 years or older
- •Written informed consent obtained before participating in the study.
- •Patient is willing and able to complete the assessments, including PRO questionnaires, as outlined in this study.
- •Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation of Ofatumumab.
- •Treatment with Ofatumumab is in accordance with the Portuguese indication of Kesimpta® (i.e., treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features).
- •Patients that have initiated Ofatumumab up to 12 M prior inclusion in the study OR Patients that are initiating Ofatumumab at the moment of study inclusion.
排除标准
- •To participate in the study, none of the following exclusion criteria must be met:
- •Use of investigational drugs during the study, OR between Ofatumumab initiation and inclusion into the study, OR within 5 half-lives of investigational drug before Ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
- •Use of high efficacy therapy (including Ocrelizumab, Natalizumab, Mitoxantrone, Rituximab and Alemtuzumab) in both cohorts prior to the initiation of Ofatumumab.
结局指标
主要结局
Proportion of patients demonstrating NEDA-3
时间窗: from month 12 up to month 24
Proportion of patients demonstrating No Evidence of Disease Activity (NEDA)-3 (12-24 months) in both cohorts, respectively. NEDA-3 is defined by no confirmed Multiple Sclerosis relapse, no new or enlarging T2 lesions, no Gadolinium-positive T1 lesions, and no six-month confirmed disability worsening.
次要结局
- Treatment Satisfaction Questionnaire for Multiple Sclerosis (TSQM-9)(Month 12, Month 24)
- Multiple Sclerosis Impact Scale Questionnaire (MSIS-29)(Baseline, Month 12, Month 24)
- Proportion of patients demonstrating no evidence of disease activity in individual components of NEDA-3(12-24 months)
- Proportion of patients demonstrating NEDA-3 in the overall population.(12-24 months)
- Proportion of patients permanently discontinuing Ofatumumab during the study(up to month 24)
- Fatigue Symptoms and Impacts Questionnaire - Relapsing Multiple Sclerosis (FSIQ-RMS)(Baseline, Month 12, Month 24)