NCT02254304已完成4 期
Prospective Phase IV Clinical Trial on Effectiveness of Rebif Treatment of CIS and RMS Patients in Romania Using Electronic Device RebiSmart™
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Percentage of Relapse-free RMS Subjects
研究概览
简要总结
This is a Phase 4, interventional, multicenter study of subcutaneous Rebif® (interferon beta-1a) using RebiSmart™ device to assess effectiveness and adherence of treatment in subjects with clinically isolated syndrome (CIS) or relapsing multiple sclerosis (RMS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects between 18 to 65 years of age
- •Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential as defined in the protocol
- •Subjects diagnosed with CIS or RMS according to the revised McDonald criteria (2010)
- •Treatment-naive subjects or subjects treated with Rebif® multi-dose injected by RebiSmart™ for no longer than 6 weeks prior to Baseline visit
- •Subjects that are able to self-inject with RebiSmart™ (in the opinion of the physician)
- •Subjects with Expanded Disability Status Scale (EDSS) score less than (<) 6 (inclusive) at Baseline
- •Signed informed consent and subject data collection form
排除标准
- •Subjects experiencing a relapse within 30 days before Baseline
- •Participation in other studies within 30 days before Baseline
- •Received any MS therapy within 6 months prior to study enrolment (for example, other disease-modifying drugs: immunomodulatory, immunosuppressive agents or combination therapy) with the exception of Rebif® multi-dose injected by RebiSmart™
- •Any visual or physical impairment that precludes the subject from self-injecting the treatment using the RebiSmart™
- •Pregnancy and breast-feeding
- •Serious or acute heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure, as per investigator opinion
- •Current or past (within the last 2 years) history of alcohol or drug abuse
- •Have any contra-indications to treatment with interferon beta-1a according to Summary of Product Characteristics
研究组 & 干预措施
Rebif in Relapsing Multiple Sclerosis (RMS) Subjects
Experimental
干预措施: Rebif (Drug)
Rebif in Clinically Isolated Syndromes (CIS) Subjects
Experimental
干预措施: Rebif (Drug)
结局指标
主要结局
Percentage of Relapse-free RMS Subjects
时间窗: Month 12
A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to multiple sclerosis (MS), accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. Relapse-free RMS subjects were those who did not had relapse during 12 month treatment period. Data was planned to be reported for "Rebif in RMS Subjects" arm.
Time to the First Relapse for CIS Subjects
时间窗: Baseline up to 12 months
A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to MS, accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. Time to the first relapse was defined as the duration from start of the treatment until first relapse. Data was planned to be reported for "Rebif in CIS Subjects" arm.
次要结局
- Percentage of Subjects With Treatment Adherence(Month 12)
- Percentage of Subjects With Relapse by Adherence Category(Month 12)
- Percentage of Subjects Who Prematurely Terminated Treatment and Reasons(Baseline up to 12 months)
- Percentage of Subjects Free From Clinical Disease Activity(Baseline up to 12 months)
- Percentage of Subjects Free From Disability Progression(Baseline up to 12 months)
- Mean Number of Relapses in RMS Subjects(Month 12)
- Number of Subjects With Reasons of Missed Injections(Baseline up to 12 months)
- Overall Evaluation of RebiSmart Use as Assessed by Investigator(Month 12)
- Healthcare Resource Utilization Questionnaire - Number of Visits to Clinic by Subjects Due to Multiple Sclerosis (MS)(Month 12)
- Healthcare Resource Utilization Questionnaire - Number of Subjects Visiting Different Types of Doctors During Their Clinical Visit(Month 12)
- Healthcare Resource Utilization Questionnaire -Number of Subjects Who Paid Someone to Assist Them Due to Multiple Sclerosis (MS)(Month 12)
- Healthcare Resource Utilization Questionnaire - Number of Visits by Healthcare Professional to Subjects' Home(Month 12)
- Healthcare Resource Utilization Questionnaire - Number of Times Subjects Visited Emergency Room Due to Multiple Sclerosis (MS)(Month 12)
- Healthcare Resource Utilization Questionnaire - Number of Days Subjects Hospitalized Due to Multiple Sclerosis (MS)(Month 12)
- Healthcare Resource Utilization Questionnaire - Number of Working Days Missed by Relative or Friend Due to Subjects' Multiple Sclerosis (MS)(Month 12)
- Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Assistant Worked for Subject Due to Multiple Sclerosis (MS)(Month 12)
- Healthcare Resource Utilization Questionnaire - Number of Subjects Whose Relatives or Friends Missed Work Due to Subjects' Multiple Sclerosis (MS)(Month 12)
- Healthcare Resource Utilization Questionnaire - Number of Days Per Week Assistant Worked For Subject Due to Multiple Sclerosis (MS)(Month 12)
- Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Full Days From Work Due to Multiple Sclerosis (MS).(Month 12)
- Healthcare Resource Utilization Questionnaire - Number of Full Days Missed From Work by Subjects(Month 12)
- Healthcare Resource Utilization Questionnaire - Number of Subjects Accomplished Less Work Due to Multiple Sclerosis (MS)(Month 12)
- Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Partial Days From Work Due to Multiple Sclerosis (MS).(Month 12)
- Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Missed From Work by Subjects(Month 12)
- Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS)(Month 12)
- Number of Subjects With Medication Adherence Based on Morisky Medication Adherence Score(Month 12)
- Number of Subjects With Adverse Event or Adverse Drug Reaction (AE/ADR), Serious AE/ADR, AE/ADR Leading to Death and AE/ADR Leading to Early Termination(Baseline up to 12 months)
- Expanded Disability Status Scale (EDSS) Score(Baseline, Month 12)
- Body Mass Index (BMI)(Baseline, Month 12)
研究者
研究点 (1)
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