NCT02142205已完成4 期
A Prospective, Open-label, Non-randomized, Clinical Trial to Evaluate the Safety and Efficacy in RUSsian RRMS Patients on One Year Treatment With Natalizumab (TYSabri®).
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 100
- 试验地点
- 11
- 主要终点
- Number of participants that experience Serious Adverse Events (SAEs) and adverse events (AEs)
研究概览
简要总结
The primary objective is to evaluate the safety and tolerability of natalizumab (BG00002, Tysabri®) in the study population (Russian participants with relapsing remitting multiple sclerosis). The secondary objectives are to look at evaluation of severity of relapse, hospitalization and steroid use requirement; Expanded Disability Status Scale (EDSS), functional tests, quality of life self-assessment questionnaires including the short form health survey self-assessment questionnaire (SF-36) and multiple sclerosis impact scale 29 (MSIS-29), evidence of MRI disease activity, participants free of disease activity (clinical activity and/MRI activity) and anti JC Virus (JCV) antibody evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be natalizumab naïve.
- •Must have a documented diagnosis of a relapsing remitting form of MS as defined by the revised McDonald Committee criteria (Polman et al., 2011)
- •Must have had at least 1 relapse in the previous year:
- •Must be stable in disability for at least 30 days prior to enrollment to the study
- •Must be stable in symptomatic management of the disease, specifically spasticity, depression and fatigue for at least 30 days prior to enrollment to the study.
- •Must be considered by the Investigator to be free of signs and symptoms suggestive of Progressive multifocal leukoencephalopathy (PML) based on medical history, physical examination, or laboratory testing.
- •Must be willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFN-beta and Glatiramer Acetate) while being treated with natalizumab during the study.
排除标准
- •Medical History:
- •Onset of a relapse within 50 days prior to first infusion.
- •Considered by the Investigator to be immunocompromised, based on medical history, physical examination, or laboratory testing or due to prior immunosuppressive treatment
- •History of, or available abnormal laboratory results indicative of, any significiant viral, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric (including major depression), renal, and/or other major disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent. The Investigator must re-review the subject's medical fitness for participation and consider any diseases that would preclude treatment.
- •History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible)
- •Known history of human immunodeficiency virus infection or hematological malignancy
- •History of organ transplantation (including anti-rejection therapy)
- •A clinically significant infectious illness (e.g. abscess, pneumonia, septicemia) within 30 days prior to the Screening Visit.
- •Treatment History:
- •Treatment with any kind of immunosuppressant medications (e.g., mitoxantrone, cyclophosphamide, cyclosporine, azathioprine, methotrexate, fingolimod, cladribine) within 6 months prior to Screening
- •Miscellaneous:
- •Female subjects who are not postmenopausal for at least 1 year, surgically sterile (does not include tubal ligation), or unwilling to practice effective contraception (as defined by the Investigator) during the study
- •Women who are breastfeeding, pregnant, or planning to become pregnant while on study
- •Other unspecified reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment into this study.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
结局指标
主要结局
Number of participants that experience Serious Adverse Events (SAEs) and adverse events (AEs)
时间窗: Up to Week 52
次要结局
- Number of new T2 hyper intense lesions(At Week 48)
- Number of newly enlarging T2 hyper intense lesions(At Week 48)
- Time course to first relapse(Up to Week 52)
- Severity of relapse as measured by the Number of relapses requiring hospitalization and the Number of relapses requiring steroid treatment(Up to Week 52)
- Number of participants that do not experience a relapse(Up to Week 52)
- Number of new hypo intense T1 lesions (black holes)(At Week 48)
- Number of conversion of Gd lesions into black holes(At Month 12)
- Annualized relapse rate (ARR)(Up to Week 52)
- Percentage of participants that do not experience a relapse as measured by an EDSS score that is not indicative of progression(At Month 12)
- Number of participates that are Anti JCV antibody positive at baseline(At Baseline)
- Percentage of participants that do not develop new GD+ and new or newly enlarging T2 hyper intense lesions(At Week 48)
- Proportion of participants free of disease activity: no clinical & no MRI activity(Up to Week 48)
- Change in EDSS scores(Up to Week 48)
- Duration of time to progression as measured by EDSS score(Up to Week 48)
- Number of participants that do not experience a progression in EDSS score(Up to Week 48)
- Percentage of participants with improvement in EDSS scores(Up to Week 48)
- Changes from baseline in nine hole peg test (9HPT)(Up to Week 48)
- Changes in Timed 25 foot walk from baseline(Up to Week 48)
- Changes in cognition as assessed by the Symbol digit modalities test (SDMT)(Up to Week 48)
- Changes from baseline in visual function test (VFT)(Up to Week 48)
- Impact on participants quality of life using SF-36 and MSIS-29 self-assessment questionnaires(Up to Week 48)
- Percentage of participants that do not experience a relapse or progression in EDSS score(Month 12)
- Number of T1 gadolinium (Gd) enhancing lesions(At Week 48)
研究者
研究点 (11)
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