NCT06949956尚未招募不适用
Administration of Fingolimod in Greek Patients With Multiple Sclerosis for the Evaluation of the Efficacy and Safety, Based on the Standard Clinical Practice.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 主要终点
- Annualized Relapse Rate, ARR
研究概览
简要总结
The goal of this observational study is to evaluate the efficacy of fingolimod through the estimation of the annualized relapse rate (ARR) over a period of 2 years.
Participants who are already taking fingolimod as part of their regular medical care for MS will answer questions about their medical history for the past 1 year and for their status for the next 2 years.
详细描述
The efficacy of fingolimod will be assessed:
- by calculating the difference in annualized relapse rate (ARR) between the 12-month period prior to study entry and that which will occur during the study at 0, 6, 12, 18 and 24 months of treatment
- by calculating the change in EDSS score between the 12-month period prior to study entry and that which will occur during the study at 0, 6, 12, 18 and 24 months of treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age.
- •Consent and compliance of participants with the treatments and procedures of the study.
- •Patients diagnosed with relapsing-remitting multiple sclerosis (RRMS) according to the revised McDonald 2017 criteria.
- •Patients who are receiving fingolimod, according to the drug's Summary of product Characteristics (SmPC).
- •Patients with available follow-up data for at least 12 months prior to their inclusion in the study, which are sufficient to calculate the annualized relapse rate.
排除标准
- •Patients under 18 years of age.
- •Patients with a contraindication to taking fingolimod according to the drug's Summary of product Characteristics (SmPC).
- •Patients with a history of mental illness, substance abuse, to a degree that may prevent their participation in the study.
- •Patients participating in another research protocol.
结局指标
主要结局
Annualized Relapse Rate, ARR
时间窗: 2 years
The difference in the annualized relapse rate (ARR) between the twelve-month period prior to study entry and that which will occur during the study.
次要结局
- Progression Independent of Relapse Activity, PIRA(2 years)
- Expanded Disability Status Scale, EDSS(2 years)
- Further calculation of Progression Independent of Relapse Activity (PIRA) taking into account clinical and imaging data (if available).(2 years)
- Quality of Life (QoL) of patients with multiple sclerosis.(2 years)
- Safety evaluation of the drug throughout the treatment period.(2 years)
研究者
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