Effectiveness and Safety of Generic Delayed-Release Dimethyl Fumarate (Sclera® or Marovarex ®, Hikma) in Routine Medical Practice in the Treatment of Relapsing-Remitting Multiple Sclerosis in MENA Region
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 6
- 主要终点
- The primary endpoint of the study is ARR (Annualized Relapse Rate) at 12 month.
研究概览
简要总结
The purpose of this observational study is to evaluate the effectiveness, safety and health related quality of life of Generic DMF (Sclera® or Marovarex ®, Hikma) in patients undergoing routine clinical care for RRMS in MENA Region
详细描述
This is an observational, multi-center, 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 initiated treatment with Generic DMF (Sclera® or Marovarex ®, Hikma) in accordance with the approved 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 Hikma Generic DMF at baseline in accordance with the approved Summary of Product Characteristics
- •Age ≥ 18 years
- •Patients who had a diagnosis of RRMS per 2010 or 2017 revised McDonald criteria who are :
- •Newly diagnosed who had no prior DMT, or
- •Switched patients who had ≥1 prior DMTs, other than DMF
- •Patients who agree to participate in the study and provide a written informed consent
排除标准
- •Patients with previous exposure to DMF other than (Sclera® or Marovarex ®-Hikma), Fumaderm (fumaric acid esters), or compounded fumarates.
- •Patients participating in other clinical studies
- •Patients who meet any of the contraindications to the administration of the Study drug according to the approved Summary of Product Characteristics
结局指标
主要结局
The primary endpoint of the study is ARR (Annualized Relapse Rate) at 12 month.
时间窗: 12 Months
Relapses will be identified and recorded by Site investigators. A relapse is defined as any new or historical neurological symptom, not associated with fever or infection, lasting for at least 24 h and accompanied by new neurological signs. New or recurrent neurologic symptoms that occurred \<30 days after the onset of a relapse as defined earlier were considered part of the same relapse.
次要结局
- Proportion of patients with Adverse Events (AEs) and Serious Adverse Events (SAEs) (including laboratory abnormalities)(up to 12 months from Initiation of Hikma DMF)
- Proportion of patients with AEs and SAEs (including laboratory abnormalities) leading to treatment discontinuation will be assessed(up to 12 months from Initiation of Hikma DMF)
- Proportion of patients experiencing a relapse over the 12 months period from Initiation of Hikma DMF(up to 12 months from Initiation of Hikma DMF)
- Time to First Relapse(up to 12 months from Initiation of Hikma DMF)
- Proportion of patients with disability progression as measured by the EDSS over time(up to 12 months from Initiation of Hikma DMF)
- Change in Multiple Sclerosis Impact Scale-29 Items (MSIS-29) scores over time(up to 12 months from Initiation of Hikma DMF)