Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Proportion of patients with AEs and SAEs (including laboratory abnormalities).
研究概览
简要总结
The purpose of this observational study is to evaluate the Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients with Relapsing-Remitting Multiple Sclerosis in Egypt
详细描述
This is an observational, prospective, cohort study, where no visits or intervention(s) additional to the daily practice will be performed. In the study sites, patients undergoing routine clinical care for RRMS and initiating treatment with generic Fingolimod in accordance with the approved summary of product characteristics (SPC) will be followed up and assessed for a total of 12 months.
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 who initiate treatment with generic Fingolimod at baseline in accordance with the approved summary of product characteristics (SPC).
- •Males and females who are ≥ 18 years old.
- •Patients who had a diagnosis of RRMS per 2010 or 2017 revised McDonald criteria, who are:
- •Newly diagnosed who had no prior Disease-Modifying Therapy (DMT), or
- •Switched patients from Gilenya®, Novartis, or
- •Switched patients from interferon beta (IFNβ).
- •Patients who agree to participate in the study and provide a written informed consent.
排除标准
- •Pregnant or lactating female patients and women of childbearing potential not using effective contraception.
- •Patients lacking immunity against varicella zoster virus (VZV).
- •Patients participating in other clinical studies.
- •Patients who meet any of the contraindications to the administration of the study drug according to the approved SPC.
结局指标
主要结局
Proportion of patients with AEs and SAEs (including laboratory abnormalities).
时间窗: up to 12 months from initiating generic Fingolimod.
Proportion of patients experiencing a relapse.
时间窗: Time frame: up to 12 months period from initiating generic Fingolimod.
Time to First Relapse (TTFR)
时间窗: up to 12 months from initiating generic Fingolimod.
Proportion of patients with disability progression as measured by the EDSS over time.
时间窗: up to 12 months from initiating generic Fingolimod.
次要结局
- Proportion of patients with AEs and SAEs (including laboratory abnormalities) leading to treatment discontinuation.(up to 12 months from initiating generic Fingolimod.)