A Phase IV Multicenter Randomized Study to Assess the Impact of a Patient Support Program (MinSupport Plus) on Health Related Quality of Life (HRQoL) and Adherence in Patients With Relapsing Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart Device
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 3
- 主要终点
- Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 12
研究概览
简要总结
This is a randomized, comparative, and multicenter study to assess the impact of a patient support program (MinSupport Plus) on health related quality of life (HRQoL) and adherence in subjects with relapsing-remitting multiple sclerosis administered Rebif® with the RebiSmart™ device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Male or female, aged 18 or older
- •A diagnosis of relapsing-remitting multiple sclerosis according to the revised McDonald Criteria (2010)
- •Treatment with Rebif® 22 or 44 mcg subcutaneously three times a week in accordance to the Summary of product characteristics
- •Rebif® administered by the RebiSmart™ device
- •Provided a signed informed consent form
排除标准
- •Has received any components, except for technical support, of MinSupport Plus prior to study entry
- •Has difficulty reading and/or understanding Swedish
- •Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude
- •No access to computer
- •Participation in another clinical study
研究组 & 干预措施
Technical support for the RebiSmart™ device
Subjects will be administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 microgram (mcg) subcutaneously (SC) 3 times a week in accordance to the summary of product characteristics (SPC) along with technical support for RebiSmart.
干预措施: Rebif® (Drug)
Subject support program (MinSupport Plus)
Subjects will be administered Rebif® by the RebiSmart™ device at a dose of either 22 or 44 mcg SC 3 times a week in accordance to the SPC along with subject support program MinSupport Plus which includes technical support for RebiSmart™ device, personal coaching regarding treatment and understanding of the disease, lifestyle guide and web support.
干预措施: Rebif® (Drug)
结局指标
主要结局
Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 12
时间窗: Baseline and Month 12
Multiple Sclerosis Impact Scale-29 (MSIS-29) is a validated MS specific questionnaire consisting of 29 questions of which 20 addressed the physical impact component and 9 assessed the psychological impact. A combined score can be generated, or both components can be reported separately. The psychological wellbeing assessment portion of the MSIS-29 was comprised of 9 questions in which subjects rate the impact of MS on their day-to-day life from 1=no impact to 5=extreme impact. The total Psychological Score was calculated using following formula: sum of score for 9 questions - 9/0.36. The total score range ranges from 0-100 where, lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a subject's functioning.
次要结局
- Change From Baseline in Modified Fatigue Impact Scale Score at Month 6 and 12(Baseline, Month 6 and 12)
- Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Total Score at Month 6 and 12(Baseline, Month 6 and 12)
- Change From Baseline in Fatigue Severity Scale (FSS) Score at Month 6 and 12(Baseline, Month 6 and 12)
- Number of Subjects With Working Ability at Month 12(Month 12)
- Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12(Month 6 and 12)
- Number of Subjects With Response Based on Health Care Personnel Satisfaction Questionnaire at Month 12(Month 12)
- Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 6(Baseline and Month 6)
- Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Visual Analogue Scale (VAS) Scale at Month 6 and 12(Baseline, Month 6 and 12)
- Percentage of Subjects With Treatment Adherence at Month 6 and 12(Month 6 and 12)
- Percentage of Subjects With Adverse Events (AE) up to Month 12(Baseline up to Month 12)
- Number of Subjects With Response Based on Subject Satisfaction Questionnaire at Month 12(Month 12)
- Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12(Month 12)
- Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Summary Score at Month 6 and 12(Baseline, Month 6 and 12)
- Change From Baseline in Modified Fatigue Impact Scale Index at Month 6 and 12(Baseline, Month 6 and 12)
- Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Month 6 and 12(Baseline, Month 6 and 12)