Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 73
- 试验地点
- 11
- 主要终点
- Change from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29)
研究概览
简要总结
The primary objective of the study is to evaluate the impact of early treatment with Tysabri in Relapsing Remitting Multiple Sclerosis (RRMS) participants on their quality of life (QoL) as measured by Multiple Sclerosis Impact Scale-29 (MSIS-29) over 2 years. The secondary objectives of the study are: to evaluate the impact of early treatment with Tysabri in RRMS participants over 2 years on the following: annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS), work productivity, quality of life (QoL) by EuroQol 5-Dimension questionnaire (EQ-5D), QoL by Subject Global Assessment of Wellbeing visual analog scale (VAS) and to evaluate clinical disease-free status (relapses, EDSS) over 2 years.
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
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent.
- •Documented diagnosis of Relapsing Multiple Sclerosis (McDonald 2010 Criteria).
- •Must have an Expanded Disability Status Scale (EDSS) score from 0 to 4.0, inclusive.
- •Must satisfy the approved therapeutic indications for Tysabri as per Product Monograph.
- •Must either be treatment naïve or have been treated with disease modifying therapy DMT(s) (such as, but not limited to, Avonex, Betaseron, Rebif, Copaxone, Extavia, Tecfidera and/or Gilenya) for ≤5 years total prior to date of informed consent.
- •Decision to treat with Tysabri must precede enrollment.
排除标准
- •Any prior treatment with Tysabri.
- •Contraindications to treatment with Tysabri as described in the Product Monograph.
- •History of progressive multifocal leukoencephalopathy (PML) or other opportunistic infections, or an increased risk for such infections.
- •History of diagnosis of Primary Progressive Multiple Sclerosis [PPMS] and/or Secondary Progressive Multiple Sclerosis [SPMS].
- •Receiving immunomodulatory or immunosuppressive therapy.
- •Prior history of immunosuppressive use (mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate, cladribine, rituximab).
- •Immunocompromised at the time of enrollment.
- •Known active malignancies (subjects with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible).
- •Women breastfeeding, pregnant, or planning to become pregnant; women who are not post-menopausal or surgically sterile who are unwilling to practice contraception.
- •Inability to comply with study requirements.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
Change from Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29)
时间窗: Baseline, Months 12 and 24
The 29-item Multiple Sclerosis Impact Scale (MSIS-29) is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient's perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.
次要结局
- Change from Baseline in Annualized Relapse Rate(Baseline, Months 12 and 24)
- Change from Baseline in Expanded Disability Status Scale (EDSS)(Baseline, Months 12 and 24)
- Change from Baseline in Work Productivity and Activity Impairment(Baseline, Months 12 and 24)
- Change from Baseline in EuroQol 5-Dimension (EQ-5D)(Baseline, Months 12 and 24)
- Percentage of participants with Clinical Disease-Free Status(Baseline, Months 12 and 24)
- Change from Baseline in Patient Global Assessment of Wellbeing Visual Analog Scale(Baseline, Months 12 and 24)