Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Relapses Post Partum
研究概览
简要总结
The purpose of this study is to evaluate if monthly natalizumab, initiated after delivery, is effective in preventing postpartum relapses.
详细描述
Postpartum patients with a diagnosis of multiple sclerosis (MS) will be given the opportunity to enroll in this study that will evaluate the efficacy of IV natalizumab to prevent postpartum relapses. Natalizumab, administered as 300mg IV q 4 weeks, will be initiated postpartum (0-30 days post-delivery).
Patients who decline natalizumab treatment postpartum will be given the opportunity to enroll in the study in the control group. The control group will have similar inclusion and exclusion criteria as well as scheduled visit and study procedures as the active natalizumab treatment group.
The primary objective of the trial is to assess the efficacy of IV administered natalizumab, monthly for 1 year, in preventing relapses during the postpartum period.
The secondary objectives of the trial are to assess the efficacy of natalizumab in decreasing the risk for disability progression during the postpartum period and to prevent the appearance of new and/or enlarging brain MRI lesions as measured by qualitative MRI analysis.
The tertiary objective is to assess the association of the clinical outcomes with subject evaluations including patient reported outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects postpartum, 0-30 days postpartum at the time of informed consent.
- •Diagnosis of relapsing form of MS.
- •Willing to initiating natalizumab and enroll in the TOUCH system.
- •Willing and able to comply with the study procedures for the duration of the trial.
- •Signed informed consent and HIPAA authorization.
排除标准
- •Diagnosis of primary progressive MS.
- •Breastfeeding
- •Use of IVIG in Tysabri treated subjects.
- •Significant renal or hepatic impairment (in the opinion of the investigator) or other significant disease (e.g., cognitive impairment) that would compromise adherence and completion of the trial.
- •History of hypersensitivity to previous exposure or presence of antibodies to natalizumab.
- •Any other factor that, in the opinion of the investigator, would make the subject unsuitable for participation in this study.
- •Patients that experience relapses and/or initiated DMT's during pregnancy
- •The Control group will consist of relapsing MS patients post-delivery who decline natalizumab therapy but open to enroll in the study.
- •Similar Inclusion and Exclusion criteria as the natalizumab group with the exception of requiring TOUCH enrollment program. The Control group will be allowed to initiate any FDA approved DMT at any time post delivery or remain on no therapy while breastfeeding.
研究组 & 干预措施
natalizumab
Participants in this group are those who opt to receive treatment with natalizumab IV 300mg/day given q 4 weeks for 48 weeks.
干预措施: Natalizumab (Drug)
结局指标
主要结局
Relapses Post Partum
时间窗: 52 weeks
The primary endpoint are the relapses during 1 year post-delivery in patients treated with natalizumab. This will be compared to the relapse frequency in the parallel control group.
次要结局
- Expanded Disability Status Scale (EDSS) Worsening(52 weeks)
- Difference in Mean Expanded Disability Status Scale (EDSS) Scores Between Persons With MS (pwMS) Treated With Natalizumab Versus Other Disease-modifying Therapies (DMT)(52 weeks)
- Change in MRI(52 weeks)
- Percent of Relapse Free Patients(52 weeks)
研究者
Bianca Weinstock-Guttman
Professor of Neurology
State University of New York at Buffalo