Post-Authorization Observational Study to Evaluate Cognition and Fatigue in RRMS Patients Treated With Rebif
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 10
- 主要终点
- Percentage of subjects with decreased/increased/stable cognition status (PASAT)
研究概览
简要总结
The study is planned to evaluate the cognitive functions in subjects with RRMS treated with interferon beta-1a, and its relationship to the fatigue and neurological dysfunction status.
详细描述
Besides the motor and sensory dysfunctions, the progression of cognitive decline is a frequent manifestation of RRMS. Fatigue is another important symptom of MS, and can negatively affect subject's Quality of life (QoL) and socio-economic functioning, including the ability to work, independent of the direct effects of disability. This is a phase IV observational, non-interventional, prospective, multicentric study to evaluate cognition in RRMS subjects treated with Rebif and its relationship to the fatigue and neurological dysfunction status. The study plans to enroll 300 subjects, across 14 centres in Czech Republic, who will be prescribed with Rebif according to its summary of product characteristics (SmPC). Assessment of cognitive and fatigue status will be done at baseline and follow-up visits at Months 3, 6, 12, 24. Subjects will be selected using the convenience method following the non-probability sampling.
OBJECTIVES
Primary Objective:
- To assess changes of cognition [measured by Paced Auditory Serial Addition Test (PASAT)] in RRMS subjects treated with Rebif
Secondary Objectives:
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with RRMS
- •Subjects eligible for treatment with Rebif as per SmPC, the Czech local guidelines and the actual Health insurance policy.
- •Subjects 18-65 years of age
- •Subjects with EDSS score < 4
- •Subjects who are willing and able to give informed consent
排除标准
- •Treatment with Rebif for more than 24 months prior the informed consent form has been obtained.
- •Subjects with history of hypersensitivity to natural or recombinant interferon-β, or to any excipients
- •Female subject who is pregnant or breast feeding and/or planning to become pregnant
- •Subjects with current severe depression and/or suicidal ideation
- •Any contraindication for Rebif therapy as per SmPC
- •Subjects with severe disability and/or any neurologic or psychiatric condition that may interfere with test performance
- •Prior treatment with interferon beta-1a i.m. or interferon beta-1b or glatiramer acetate.
结局指标
主要结局
Percentage of subjects with decreased/increased/stable cognition status (PASAT)
时间窗: Baseline vs Month 6 - 12 - 24
次要结局
- Percentage of subjects with decreased/increased/stable fatigue (FDS)(Baseline vs Month 6- 12 - 24)
- Relationship between the cognition status, the fatigue status and the EDSS status(Baseline, Month 6- 12 - 24)
- Relationship between the Rebif dosage used with cognition and fatigue status(Baseline, Month 6- 12 - 24)
- Proportion of relapse-free subjects(Month 3 - 6 - 12 - 24)
- Proportion of subjects with defined EDSS changes (decrease; no change; increase of 0.5 - 1.0; 1.5 - 2.0; 2.5 - 3.0; 3.0 or more points, respectively)(Month 6 - 12 - 24)
- Proportion of subjects without either relapse, EDSS progression, cognition status decrease and fatigue increase(Month 6 - 12- 24)
- Number of Rebif doses not taken since the last study visit, and the reason of dose not taken(Month 3 - 6 - 12 - 24)
- Proportion of subjects using the antidepressive or antifatigue medication(Baseline, Month 3 - 6 - 12 - 24)