NCT04832399已完成不适用
Tysabri in Early Relapsing Remitting Multiple Sclerosis Patients - TYPIFI (Tysabri Patient Initiation After Failure of the Initial DMT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical Disease-Free Status at Month 12 in Comparison to the Previous Year
研究概览
简要总结
The purpose of this study is to evaluate the impact of an early treatment with Natalizumab on the management of the progressive nature of Relapsing Remitting Multiple Sclerosis (RRMS).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of Relapsing Remitting Multiple Sclerosis (McDonald 2010 Criteria).
- •EDSS ≤ 3.
- •Must fulfill Tysabri indication (relapse and MRI criteria).
- •Decision to start treatment with Natalizumab must precede enrollment.
- •Up to four natalizumab infusions.
排除标准
- •Any prior treatment with Natalizumab.
- •Prior imunossupressive treatment (Mitoxantrone, Azathioprine, Methotrexate, Cyclophosphamide, Mycophenolate, Cladribine, Rituximab).
- •Contraindications to treatment with Natalizumab.
- •History of Progressive Multifocal Leukoencephalopathy (PML) or other opportunistic infections, or an increased risk for such infections.
- •Immunocompromised at the time of enrollment. Known active malignancies.
- •Inability to comply with study requirements.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Natalizumab
Natalizumab 300 mg is administered by intravenous infusion once every 4 weeks.
干预措施: Natalizumab (Drug)
结局指标
主要结局
Clinical Disease-Free Status at Month 12 in Comparison to the Previous Year
时间窗: Month 12
Overall Disease-Free Status at Month 12
时间窗: Month 12
Annualized Relapse Rate at Month 12 in Comparison to the Previous Year
时间窗: Month 12
次要结局
- Change From Baseline in Ability to Work and Productivity as Assessed by Work Productivity and Activity Impairment (WPAI) Questionnaire(Months 12, 24, 36 and 48)
- Quality of life (QoL) Assessed Using Fatigue Severity Scale(Months 12, 24, 36 and 48)
- Annualized Relapse Rate (ARR)(Months 12, 24, 36 and 48)
- Overall Disease-Free Status at Months 24, 36 and 48(Months 24, 36 and 48)
- Clinical Disease-free Status Every 6 Months(Every 6 months (Up to 48 months))
- Change From Baseline in Sustained Expanded Disability Status Scale (EDSS) Score (24-week Sustained)(Months 12, 24, 36 and 48)
- MRI measures: T2, T1, T1 with Gadolinium (Gd)(Months 12, 24, 36 and 48)
- Cognitive Impairment Using Symbol Digit Modalities Test (SDMT)(Months 12, 24, 36 and 48)
- QoL assessed using Multiple Sclerosis Functional Composite (MSFC) Test(Months 12, 24, 36 and 48)
- QoL Assessed Using Beck Depression Inventory, 2nd Edition (BDI-II)(Months 12, 24, 36 and 48)
- QoL Assessed Using Multiple Sclerosis Impact Scale (MSIS-29)(Months 12, 24, 36 and 48)
研究者
研究点 (1)
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