Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study (KOSMOS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 13
- 主要终点
- Proportion of patients with no evidence of disease activity (NEDA-3)
研究概览
简要总结
This is a multi-center, observational study carried out in Switzerland that aims to describe the effects of Ofatumumab in a setting of routine medical care.
详细描述
This non-interventional study will observe the effect of Ofatumumab treatment compared to the standard of care (SoC) arm of a closely monitored phase-IIIb study (STHENOS-COMB157G3301) in MS patients in a real-world setting in Switzerland over an observational period of 12 month.
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
- •Written informed consent must be obtained before participating in the study.
- •Diagnosis of RMS per McDonald Criteria (2017) occurred within 3 years prior to initiation of Ofatumumab.
- •Adult patients who have been on treatment with Ofatumumab for at least 3 months, but not longer than 12 months prior to inclusion in the study.
- •Ofatumumab treatment in line with the Swiss Kesimpta® label (i.e. adult patients with active, relapsing forms of MS)
- •Patient is willing and able to complete patient diary during course of the study, as well as to complete PRO questionnaires.
排除标准
- •Use of investigational drugs during the study, OR between Ofatumumab initiation and inclusion into the study, OR within 3 months before Ofatumumab initiation, OR within 5 half-lives of investigational drug before Ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
- •Subjects who are not able to provide consent due to incapable judgement
研究组 & 干预措施
Ofatumumab
Population under routine medical care prescribed Ofatumumab in an early Relapsing Multiple Sclerosis
干预措施: Ofatumumab (Other)
结局指标
主要结局
Proportion of patients with no evidence of disease activity (NEDA-3)
时间窗: Month 12
No evidence of disease activity (NEDA-3), as defined by no confirmed MS relapse, no new or enlarging T2 lesions, no Gadolinium-positive T1 lesions, and no six-month confirmed disability worsening, as compared to the SoC arm of STHENOS.
次要结局
- Proportion of patients demonstrating NEDA-3(Month 12)
- Treatment satisfaction with Ofatumumab as measured by TSQM-9(Month 12)
- Proportion of patients permanently discontinuing Ofatumumab(Month 12)
- Proportion of patients demonstrating no evidence of disease activity in individual components of NEDA-3(Month 12)
- Proportion of patients with previous DMT medication(Baseline)
- Proportion of participants with a cumulative treatment interruption of more than six months(Month 12)
- Proportion of patients with clinical and MRI parameters(Baseline)
- Proportion of Ofatumumab doses not completed(Month 12)
- Adherence to Ofatumumab(Month 12)
- Interdependency of adherence and clinical outcome in terms of NEDA-3(Month 12)
- Treatment effect of Ofatumumab on the impact of multiple sclerosis as measured by MSIS-29(Month 12)