This is a Non-interventional, Prospective, Multicenter Study Conducted in France. The Primary Objective of This Study is to Describe the Quality of Life of MS Patients After Initiation of Treatment With Ofatumumab.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 302
- 试验地点
- 49
- 主要终点
- Quality of life - MUSIQoL questionnaire
研究概览
简要总结
SEPROS is a non-interventional study, based on primary data collection of MS adult patients who initiated ofatumumab as per neurologist practice and regardless of the study protocol.
详细描述
This is a non-interventional, prospective (primary data), multicenter study conducted in metropolitan France. The primary objective of this study is to describe the quality of life of MS patients after initiation of treatment with ofatumumab.
In order to form a representative sample of MS patients taking into account the terms of care in France, free or practicing neurologists in healthcare institutions (public or private) in different regions of France will be selected to participate in this study.
The study will enroll adult patients with MS who initiated ofatumumab according to the physician's advice and independently of the study. Patients will be followed from initiation of ofatumumab either until (i) 12 months (± 1month) after initiation of ofatumumab (End of Study), or until (ii) discontinuation of treatment with ofatumumab prior to the completion of the 12-month follow-up (early termination); whichever occurs first (end of study or early termination).
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
- •Male or female, 18 years of age or older
- •Patient with confirmed MS diagnosis
- •Patient initiating treatment with ofatumumab for the first time
- •Patient for which the decision to initiate treatment with ofatumumab was made by the doctor (investigator) in accordance with his/her usual practices independently of the study
- •Patient not opposed to participation in this study
- •Patient willing and able to complete patient questionnaires
排除标准
- •1. Patient treated with ofatumumab in the context of a clinical trial
研究组 & 干预措施
ofatumumab
MS adult patients who initiated ofatumumab as per neurologist practice and regardless of the study protocol
干预措施: ofatumumab (Other)
结局指标
主要结局
Quality of life - MUSIQoL questionnaire
时间窗: 12 months
The primary objective of this non-interventional study is to describe the quality of life of adult patients with MS treated with ofatumumab in real life, in France, after 12 months of treatment with ofatumumab using the MUSIQoL Quality of Life Questionnaire. The MuSiQoL measures MS-specific quality of life. It comprises 31 items covering 9 domains (activities of daily living, psychological well-being, symptoms, relationships with friends, relationships with family, relationships with the healthcare system, sentimental and sexual life, coping, and rejection). Each item is scored on a 6-point Likert scale. The score on each dimension is obtained by computing the mean of the item scores for that dimension. All dimension scores are linearly transformed to a 0-100 scale. The global index score is computed as the mean of the dimension scores. Higher scores represent higher quality of life.
次要结局
- Ofatumumab discontinuation(12 months)
- Persistence on ofatumumab(Month 6, Month 12)
- Neurologist's decision criteria for initiating ofatumumab and patient involvement in the treatment choice(Baseline)
- Number of patient adherent to ofatumumab from patient and practitioner perspectives(12 months)
- Impact of MS on professional activity using the 6-item WPAI questionnaire(12 months)
- Clinical evolution of Multiple sclerosis - EDSS score(12 months)
- Clinical evolution of Multiple sclerosis - Number of patients with relapses(Up to 12 months)
- Treatment satisfaction of patients treated with ofatumumab using TSQM 9 questionnaire(12 months)