A Non-interventional Study Evaluating Kesimpta® (Ofatumumab) Treatment Effects in Patients With Relapsing Multiple Sclerosis Transitioning From Other Therapies [KAIROS]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 307
- 试验地点
- 41
- 主要终点
- Reasons for recent therapy switch to ofatumumab
研究概览
简要总结
KAIROS was a prospective, multicenter, non-interventional study (NIS) in Germany. Prospective, primary data was collected via questionnaires and an electronic case report form (eCRF) over a period of one year (max. 1.5 years) of treatment. Additionally, medical history of participants was collected including disease duration, EDSS, MRI parameters and relapses.
详细描述
The decision for ofatumumab as routine medical treatment must have been taken independently of and prior to the study start. During the observation phase of the study, data was collected according to standard of care as recommended by KKNMS (Competence Network Multiple Sclerosis in Germany).
The prospective observational period per patient was up to approx. one year from the time of consent (1 year ± 2 months visit window + potentially 6 months follow-up to confirm disability worsening in patients who showed increase in EDSS within 6 months prior to EOS). The observational period was not dictated by the protocol. The follow-up documentation took place at a frequency defined as per investigator's discretion. The diagnostic or monitoring procedures were only those ordinarily applied to the therapeutic strategy and to routine clinical care, could be performed as telemedicine visits and took place as per investigator's discretion.
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) (Thompson, Banwell et al. 2018)
- •Prior treatment with EU approved DMT for MS other than ofatumumab
- •Decision for treatment initiation of ofatumumab (Kesimpta®) prior to study participation and planned initiation of ofatumumab after respective wash-out period of prior DMT (if applicable) or performed initiation of ofatumumab within the last 14 days
- •Ofatumumab treatment in line with the German label
排除标准
- •Use of investigational drugs during 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
- •Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with ofatumumab
结局指标
主要结局
Reasons for recent therapy switch to ofatumumab
时间窗: Baseline
Reasons for recent therapy switch to ofatumumab will be collected
次要结局
- Proportion of missed ofatumumab doses(12 months)
- Proportion of patients demonstrating the individual NEDA-3 components(Baseline, month 12)
- Duration of treatment interruptions per patient(12 months)
- Proportion of patients permanently discontinuing ofatumumab during the study by planned next DMT(12 months)
- Change on Multiple Sclerosis Impact Scale 29 (MSIS-29) as compared to baseline in general and depending on reasons for treatment switch(Baseline, month 6, month 12)
- Proportion of patient subgroups with and without 100% adherence depending on different characteristics(12 months)
- Fatigue Scale for Motor and Cognitive Functions (FSMC) compared to baseline in general and depending on reasons for treatment switch(Baseline, month 6, month 12)
- Number of patients by reasons for treatment interruptions(12 months)
- Number of treatment interruptions per patient(12 months)
- Proportion of patients permanently discontinuing ofatumumab during the study by reason for discontinuation(12 months)
- Percentage of patients with no clinical evidence of disease activity (NEDA)(Baseline, month 6, month 12)
- Treatment Satisfaction Questionnaire for Medication (TSQM) 1.4 as compared to baseline in general and depending on reasons for treatment switch(Baseline, month 6, month 12)
- The proportion of subjects discontinuing treatment due to insufficient effectiveness (lack of effectiveness) or tolerability/safety reasons(12 months)
- Number of participants with injection related AEs(12 months)