EUCTR2010-021978-11-IE进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 856
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •To be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of randomization (Day 0), or at the timepoint specified in the individual eligibility criterion listed:
- •1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- •2. Be between the ages of 18 and 58, inclusive, at the time of informed consent.
- •3. Onset of SPMS at least 2 years prior to enrollment. SPMS is defined as relapsing-remitting disease followed by progression of disability independent of or not explained by MS relapses (Lublin, Reingold, 1996) ) for at least 2 years.
- •4. Have EDSS score of 3.0 to 6.5, inclusive.
- •5. Have an MS Severity Score (MSSS) of 4 or higher.
- •6. Have documented confirmed evidence of disease progression independent of clinical relapses over the 1 year prior to enrollment as defined in the Study Reference Guide.
- •7. Subjects must have completed those baseline assessments associated with components of the primary endpoint (EDSS, T25FW, 9HPT) prior to randomization (Day 0).
- •8. Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last infusion.
- •To be eligible to participate in the Part 2 Extension Phase of this study, candidates must meet the following eligibility criteria at the time of consent into Part 2, or at the timepoint specified in the individual eligibility criterion listed:
- •1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use PHI in accordance with national and local subject privacy regulations.
- •2. Subjects must have participated in and completed Part 1 per protocol, and have documented Week 108 assessment attempts for EDSS, T25FW, and 9HPT prior to first open-label dosing at Week 108.
- •3. Subjects of childbearing potential must practice effective
- •contraception during the study and be able to continue contraception for 3 months after their last infusion.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 856
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Candidates will be excluded from study entry if any of following exist at time of randomization (Day 0) or at timepoint specified in individual criterion listed
- •1.Have a diagnosis of RRMS or PPMS as defined by revised McDonald Committee criteria
- •2.Had recent clinical relapse (within 3 mos) prior to randomization
- •3.Have T25FW test of >30 secs during screening period
- •4.Any value below lower limit of normal for blood levels of leukocytes, lymphocytes, or neutrophils
- •5.Considered by Investigator to be immunocompromised based on
- •medical history, physical examination, laboratory testing, or any other testing required by local guidelines or due to prior immunosuppressive or immunomodulating treatment
- •6.Subjects for whom MRI is contraindicated (ie have pacemakers or
- •other contraindicated implanted metal devices, are allergic to gadolinium, or have claustrophobia that cannot be medically managed)
- •7.History of any clinically significant (as determined by Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, and renal or other major disease that would preclude participation in a clinical study
- •8.History of malignant disease, including solid tumors and hematologic malignancies (with exception of basal cell and squamous cell carcinomas of skin that have been completely excised and are considered cured)
- •9.Known history of or positive test result for HIV
- •10.Positive test result for HCV or HBV (test for hepatitis B surface
- •antigen and/or hepatitis B core antibody)
- •11.History of transplantation or any antirejection therapy
- •12.Presence of any infectious disease (eg cellulitis, abscess, pneumonia, septicemia) within 30 days prior to screening
- •13.History of PML or other opportunistic infections including active
- •tuberculosis
- •14.Any prior treatment with cell-depleting therapies, including total
- •lymphoid irradiation, cladribine, rituximab, alemtuzumab or bone
- •marrow ablation
- •15.Any prior treatment with natalizumab
- •16.Treatment with mitoxantrone, cyclophosphamide, cyclosporine,
- •azathioprine, methotrexate, mycophenolate mofetil, T cell or T cell
- •receptor vaccination, fingolimod, daclizumab, or cytapheresis within 6 months prior to randomization
- •17.Treatment with IV or oral corticosteroids, IvIg, or plasmapheresis for treatment of MS within 3 mos prior to randomization
- •18.Treatment with glatiramer acetate or any interferon beta
- •preparations within 4 wks prior to randomization
- •19.Treatment with 4-aminopyridine within 30 days prior to
- •randomization unless a stable dose has been maintained for at least 30 days prior to randomization and will be continued for the course of this study
- •20.Female subjects considering becoming pregnant while in the study
- •21.Female subjects of childbearing potential who have positive
- •pregnancy test at either Screening Visit or Wk 0
- •22.Female subjects who are pregnant or currently breastfeeding
- •23.History of drug or alcohol abuse in opinion of Investigator within 2 years prior to entry
- •24.Unwillingness or inability to comply with the requirements of protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with protocol
- •25.Participation in any other investigational treatment study within 3 mos prior to screening or concurrent with this study
- •26.Any prescheduled elective procedure during study period that in
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