A Multicenter, Prospective, Non-interventional Study to Assess Adherence to Treatment for patIeNts With RMS Who Are Prescribed Subcutaneous (sc) Interferon Beta-1a (MAIN-MS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 594
- 试验地点
- 4
- 主要终点
- Percentage adherence of subjects on Rebif, using the Morisky Green Levine Medication Adherence Scale (MGLS) Score
研究概览
简要总结
This is an open label, non randomized, uncontrolled, multicenter, single arm observational study. In this study, the enrolled subjects will be treated with Rebif human serum albumin (HSA)-free formulation (with or without RebiSmart) 44 microgram (mcg), subcutaneous (sc), thrice in a week (tiw) for 24 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged more than or equal to (>=) 18 years and less than or equal to (<=) 60 years at the time of Rebif introduction
- •Subjects diagnosed with RMS according to the revised McDonald criteria (2010)
- •Treatment naïve or subjects on other DMDs who will switch to Rebif.
- •Subjects will receive 1st Rebif 44 mcg dose after signing informed consent
- •Subjects willing and able to provide signed informed consent.
排除标准
- •Have any contraindications to treatment with IFN beta-1a sc according to European summary of product characteristics (EU SPC)/prescribed information
- •Subjects participating in other clinical studies/trials
- •Any female subject of childbearing potential who is not on contraceptives
- •Subjects refusal to participate in the study.
研究组 & 干预措施
Relapsing Multiple Sclerosis (RMS) group
Subjects diagnosed with RMS who are prescribed Rebif (Interferon beta-1a)
干预措施: Rebif (Interferon beta-1a) (Drug)
结局指标
主要结局
Percentage adherence of subjects on Rebif, using the Morisky Green Levine Medication Adherence Scale (MGLS) Score
时间窗: Month 24
MGLS is a four item self-reported questionnaire to assess medication adherence. It consists of four questions/items evaluating drug intake habits in subjects on chronic therapies with a scoring scheme of "Yes" = 1 (no adherence) and "No" = 0 (adherence). The items are summed to give an overall score, which ranges from 0 to 4 where high adherence=0, medium adherence=1-2 or low adherence=3-4.
次要结局
- Percentage of relapse-free subjects(Month 24)
- Percentage of relapse-free subjects based on MGLS Score(Up to 24 month)
- Percentage of subjects on Rebif who discontinued the treatment(up to 24 months)
- Time to treatment discontinuation(up to 24 months)
- Number of subjects with suspected adverse drug reactions (ADRs) related to Rebif treatment and concomitant therapy over the 24 months of the study(Up to 24 months)
- Reason for treatment discontinuation(up to 24 months)
- Percentage of subjects with expanded disability status scale (EDSS) progression(Month 24)