NCT01433250已完成2 期
An Open Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients With Relapsing-remitting Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments
研究概览
简要总结
The study will assess the long-term safety and tolerability of AIN457 in patients with relapsing-remitting multiple sclerosis (RRMS). In addition the long-term pattern of maintenance of efficacy and health related quality of life will be explored.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Was exposed to AIN457 or placebo in study CAIN457B2201 and completed the CAIN457B2201 study, up to at and including Visit 10 (week 24).
排除标准
- •Have been treated with:
- •immunosuppressive medications such as azathioprine or methotrexate within 1 month prior to enrollment, if lymphocyte count normal.
- •immunoglobulins and/or monoclonal antibodies (with the exception of AIN457) within 2 month prior to enrollment, or if the immunosuppressive effects are likely to persist at enrollment (such as presence of B cell depletion after rituximab treatment).
- •Have received total lymphoid irradiation, bone marrow transplantation, alemtuzumab, cladribine, cyclophosphamide, mitoxantrone or other immunosuppressive treatments with long-lasting (over 6 months) or permanent effects.
- •Have received any live or live attenuated vaccines (including live vaccines for varicella-zoster virus or measles) within 2 months prior to enrollment.
- •A diagnosis of chronic disease of the immune system other than MS, or of an immunodeficiency syndrome.
- •Current severe depression.
- •Pregnant or nursing (lactating) women.
- •Malignancy diagnosed since enrollment in the core study (except for successfully-treated basal or squamous cell carcinoma of skin).
- •A new diagnosis of diabetes
- •Positive testing for tuberculosis (QuantiFeron or chest X-ray).
- •Subjects with clinically significant cardiac abnormalities
- •Unable or unwilling to undergo multiple venipunctures
- •Unable to undergo MRI scans due to newly acquired claustrophobia or metallic implants incompatible with MRI.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
AIN 457 Core
Experimental
(10mg/kg i.v.). AIN 457 core study /AIN 457 Extension
干预措施: AIN457 (Drug)
AIN457 Placebo Core
Experimental
(10mg/kg i.v.). AIN 457 placebo core study /AIN 457 Extension
干预措施: AIN457 (Drug)
结局指标
主要结局
Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments
时间窗: 97 weeks
Safety outcomes will be described in Adverse events section as there was not an efficacy primary outcome
次要结局
- Distribution of Patients With Relapses to End of Study (EOS) (All Subjects)(week 97)
- Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI(weeks 13,25,37,53,73 and 97)
- Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI(weeks 13,25,37,53,73 and 97)
- Change in Brain Volume at End of Study.(week 97)
- Measure of Disability: Expanded Disability Status Scale (EDSS).(Baseline to week 97)
研究者
研究点 (1)
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