An ITAlian Observational, Multicenter, 12-month, Single-arm Study to Evaluate the Effectiveness and Safety of Treatment With Ofatumumab (Kesimpta®) in a pOpulation of RRMS Patients in a Real-world Setting - the ITAKOS Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 379
- 试验地点
- 31
- 主要终点
- Annualized relapse rate (ARR)
研究概览
简要总结
Study to evaluate the effectiveness of ofatumumab in Italian RRMS patients in the real-life setting.
详细描述
Prospective real-world data on ofatumumab is still very limited. For this reason, the main aim of this study is to investigate the impact of ofatumumab in a population of Italian RRMS patients in routine clinical practice to evaluate if ofatumumab is able in these conditions to provide relevant clinical benefits that comprehensively encompass anti-inflammatory activity (relapses), disability accumulation, cognitive impairment, fatigue symptoms and quality of life.
This is an observational, multicenter, single-arm, prospective study. Prospective data will be collected on patients newly treated with ofatumumab over an observational period of 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Male or female outpatients ≥18 years old.
- •Patients diagnosed with RRMS (McDonald criteria 2017).
- •Patients newly treated with ofatumumab, for whom the decision to start treatment with the drug has already been taken independently from study inclusion, based on clinical practice and according to the SmPC and to AIFA reimbursement criteria and who already successfully qualified for treatment with ofatumumab (i.e., passed the screening procedure mandated by the SmPC and the Risk Management Plan (RMP) for this treatment).
- •Patient or a legal representative of the patient must provide written informed consent before any study assessment is performed.
排除标准
- •Patients outside the approved label of ofatumumab.
- •Pregnant and lactating women.
- •Patients with any clinical condition that may interfere with the subject's ability to cooperate and comply with the study procedures based on investigator's judgement.
- •Patients cannot participate in this non-interventional study if they also participate in an interventional trial.
- •Treatment with ofatumumab prior to inclusion in this study or after 7 days from baseline visit.
研究组 & 干预措施
Ofatumumab
Patients treated with Ofatumumab
干预措施: Ofatumumab (Drug)
结局指标
主要结局
Annualized relapse rate (ARR)
时间窗: 1 year
Annualized relapse rate (ARR) after a maximum observation period of 12 months of ofatumumab treatment. ARR is the number of confirmed relapses in a year, calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of time in study.
次要结局
- Fatigue Severity Scale [FSS](Baseline, month 3, month 6 and month 12)
- Expanded Disability Status Scale (EDSS)(Baseline, month 12 months)
- Variation of NfL in plasma(Baseline, month 6 and month 12)
- Discontinuation rates due to AE and/or other reasons(12 months)
- Treatment satisfaction assessed by TSQM-9(Month 6, month 12)
- Proportion of patients with an improvement in SDMT (Symbol Digit Modality Test)(Baseline, month 6, month 12)
- Quality of life parameters assessed by EQ-5D-3L(Baseline, 12 months)
- Adverse Events (AEs)(12 months)