Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif® New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Incidence and type of injection site reactions (ISRs)
研究概览
简要总结
This observational multicentric study is planned to assess the tolerability of Rebif New Formulation in an Australian clinical setting by the incidence of injection site reactions (ISRs). The study will allow the comparison of tolerability data with historical data for both Rebif New and classic formulations, and will do so by using the same pre- specified preferred terms of treatment emergent adverse events as done in historical studies. In addition, the study will analyse whether interaction(s) with a nurse impacts tolerability and the impact of Rebif New Formulation on the patient's Quality of Life.
详细描述
The disease-modifying therapies for multiple sclerosis (MS) aim to slow down the disease process and consequent damage to central nervous system. This study is an open-label, multicentric study planned to assess the tolerability of Rebif New Formulation in an Australian clinical setting by the incidence of ISRs. A total of 100 subjects having relapsing MS across approximately 20 sites in Australia will be enrolled into the study. Subject visits will be scheduled at baseline (month 0) and months 3, 6, 9 and 12 and the data related to demographic factors, disease history, quality of life and adverse drug reactions (ADRs) will be recorded in the case report form (CRF).
OBJECTIVES
Primary Objective:
- To assess the tolerability of Rebif New Formulation in an Australian clinical setting by the incidence of ISRs
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory patients with Multiple Sclerosis who:
- •have experienced two or more relapses within the last 2 years. or
- •are not tolerating their current MS therapy.
- •Patients 18 years of age or over.
- •Patients with Expanded Disability Status Scale (EDSS) score <6.
- •Patients who have given informed consent to participate in the study.
排除标准
- •Subjects with diagnosis of any other form of MS other than relapsing MS.
- •Contra-indicated medical conditions for IFN beta-1a as defined in the Product Information i.e: women who are or plan to become pregnant whilst on therapy; subject with severe depressive disorders and/or suicidal ideation and; epileptic subjects with seizures not adequately controlled by treatment
- •Subjects with a known hypersensitivity to natural or recombinant interferon beta, mannitol, poloxamer, methionine, sodium acetate buffer or benzyl alcohol.
- •Subjects who are pregnant and/or breastfeeding.
- •Subjects currently on Rebif New Formulation.
- •Subjects currently experiencing a relapse.
结局指标
主要结局
Incidence and type of injection site reactions (ISRs)
时间窗: Month 3, 6, 9 and 12
次要结局
- Relapse rate(Month 3, 6, 9 and 12.)
- Number of missed injections of Rebif New Formulation since the previous visit(Month 3, 6, 9 and 12)
- Changes in quality of life (MusiQoL)(Baseline visit and at Month 6 and 12)
- Number and type (telephone, face-to-face, written) of interactions with nurse support(Month 3, 6, 9 and 12)
- Reasons for missed injections of Rebif New Formulation since the previous visit(Month 3, 6, 9 and 12)
- Proportion of subjects with dose reductions to 22 mcg as a result of tolerability(Month 3, 6, 9 and 12)