A Prospective, Multi-center, Observational Study to Assess the Tolerability of Interferon-beta 1-A (Rebif®) Therapy for Korean Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of subjects with moderate to severe (grade 3-5) injection site reactions based on pain, bruising and/or transient (<24 hours) erythema; inflammation alone and with induration; necrosis at injection site; plastic surgery required for necrosis
研究概览
简要总结
This is an observational study to assess the tolerability of Rebif treatment in Korean multiple sclerosis (MS) subjects.
详细描述
The present observational study is being conducted to assess the safety information from a target of 100 Korean subjects with MS treated with Rebif. Various parameters like subjects' background (age, sex, BMI), MS history, MS status (MS type, Expanded Disability Status Score [EDSS] and others), MS Treatment Concern Questionnaire (MSTCQ), Rebif treatment status, concomitant disease modifying agents (DMA) therapy and Rebif related adverse events will be collected. Subjects will be followed for 12 months. Proportion of subjects with moderate to severe (Grade 3-5) injection site reactions after 3, 6, 12 months of Rebif treatment will be determined. Secondary outcomes like annual relapse rate, change in EDSS, changes in MSTCQ, time to first relapse and incidence of side effects associated with Rebif therapy will also be determined and presented descriptively.
OBJECTIVES
Primary objectives
- To assess the tolerability of Rebif treatment in Korean MS subjects in a non-interventional setting Secondary Objectives
- To evaluate subject's satisfaction, clinical data and disease characteristics of the population of MS subjects undergoing Rebif treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects, who are eligible for Rebif treatment according to the indication in the national label of Rebif in Korean subjects with MS. The national labels approved by Korean Regulatory Authority are:
- •Subjects with relapsing MS with two or more acute exacerbations in the previous two years
- •Subjects with secondary progressive MS with ongoing relapsing activity
- •Subjects who sign the informed consent form.
排除标准
- •Initiation of treatment in pregnancy.
- •Subjects with a history of hypersensitivity to natural or recombinant interferon-ß, or to any excipients.
- •Subjects with current severe depression and/or suicidal ideation.
结局指标
主要结局
Proportion of subjects with moderate to severe (grade 3-5) injection site reactions based on pain, bruising and/or transient (<24 hours) erythema; inflammation alone and with induration; necrosis at injection site; plastic surgery required for necrosis
时间窗: After 3, 6 and 12 months of Rebif treatment
次要结局
- Annual relapse rate(Baseline to 12 months observation period)
- Change in EDSS(Baseline to 12 months observation period)
- Change in MSTCQ(Baseline to 12 months observation period)
- Time to first relapse(Baseline to 12 months observation period)
- Incidence of side effects associated with Rebif therapy(Baseline to 12 months observation period)