Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients (RENEW)
2013年10月21日 更新者：EMD Serono
The overall objective of this study is to collect data relevant to the tolerability of Novantrone® therapy in patients with multiple sclerosis (MS) using dosing and monitoring recommendations specified in the package insert.
研究概览
地位
完全的
条件
详细说明
This phase IV, multicenter, prospective, open-label tolerability and safety monitoring study will enroll a select cohort of 500 multiple sclerosis patients receiving commercially available Novantrone®. The patients will be assessed every 3 months during treatment followed by annual assessment for a total of five (5) years.
The select cohort of MS patients enrolled will have secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting disease (i.e., patients whose neurological status is significantly abnormal between relapses).
The overall objective of this study is to collect data relevant to the tolerability of Novantrone® therapy in patients with multiple sclerosis (MS) using dosing and monitoring recommendations specified in the package insert.
研究类型
观察性的
注册 (实际的)
509
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Kentucky
-
Lexington、Kentucky、美国、40504-3276
- Registrat Inc
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Male and female patients with a clinically definite or laboratory supported diagnosis of MS and having secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting disease (i.e., patients whose neurologic status is significantly abnormal between relapses).
Patients with primary progressive disease will not be included in this study.
描述
Inclusion Criteria:
- To be eligible for inclusion into this study, the subjects must fulfill all of the following criteria:
- Platelet count >100,000 cells/µL
- Granulocyte count > 2000 cells/µL
- Age 18-65 years
- Negative pregnancy test for female patients who are biologically capable of becoming pregnant, even if they are taking birth control
- For patients of reproductive age, agreement to practice effective contraception throughout the study and for 6 months following the last administration of Novantrone®
- Signed Inform Consent.
Exclusion Criteria:
- To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
- Presence of cardiac risk factors:
- History of congestive heart failure
- LVEF < 50% determined by echocardiography or MUGA
- Previous treatment with Novantrone®, other anthracenediones, or anthracyclines
- Prior mediastinal radiotherapy or total lymphoidal irradiation
- AST, ALT, bilirubin > 2x upper limits of normal
- Severe untreated infection (including current urinary tract infection)
- Nursing or pregnant women)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Congestive Heart Failure (Treatment Phase)
大体时间：up to 36 months
|
Number of patients experiencing congestive heart failure during the treatment phase of the trial
|
up to 36 months
|
|
Congestive Heart Failure (Annual Follow-Up Phase)
大体时间：up to 5 years
|
Number of patients experiencing congestive heart failure during the annual follow-up phase of the trial
|
up to 5 years
|
|
Left Ventricular Ejection Fraction (Treatment Phase)
大体时间：up to 36 months
|
Number of patients with left ventricular ejection fraction test results that decreased below 50% during the treatment phase of the trial
|
up to 36 months
|
|
Left Ventricular Ejection Fraction (Annual Follow-Up Phase)
大体时间：up to 5 years
|
Number of patients with left ventricular ejection fraction test results that decreased below 50% during the annual follow-up phase of the trial
|
up to 5 years
|
|
Serious Infections (Treatment Phase)
大体时间：up to 36 months
|
Number of serious infections during the treatment phase of the trial
|
up to 36 months
|
|
Serious Infections (Annual Follow-Up Phase)
大体时间：up to 5 years
|
Number of serious infections during the annual follow-up phase of the trial
|
up to 5 years
|
|
IV Antibiotics (Individual Drugs Unspecified) Utilized Due to Serious Infection (Treatment Phase)
大体时间：up to 36 months
|
Number of subjects in whom IV antibiotics were utilized due to serious infection during the treatment phase
|
up to 36 months
|
|
IV Antibiotics (Individual Drugs Unspecified) Utilized Due To Serious Infection (Annual Follow-Up Phase)
大体时间：up to 5 years
|
Number of subjects in whom IV antibiotics were utilized due to serious infection during the annual follow-up phase
|
up to 5 years
|
|
Severe Neutropenia (Treatment Phase)
大体时间：up to 36 months
|
Number of infections associated with severe neutropenia at onset during the treatment phase
|
up to 36 months
|
|
Severe Neutropenia (Annual Follow-Up Phase)
大体时间：up to 5 years
|
Number of infections associated with severe neutropenia at onset during the annual follow-up phase
|
up to 5 years
|
|
Clinical Relapses (Treatment Phase)
大体时间：up to 36 months
|
Number of clinical relapses reported during the treatment phase of the trial
|
up to 36 months
|
|
Clinical Relapses (Annual Follow-Up Phase)
大体时间：up to 5 years
|
Number of clinical relapses reported during the annual follow-up phase of the trial
|
up to 5 years
|
|
Symptomatic CHF, Left Ventricular Ejection Fraction - Prior to Each Dose • Serious Infections, IV Antibiotics, or Assoc w/ Severe Neutropenia-evaluated. Novantrone Admin - Per PI • SAE, Clinical Relapses
大体时间：up to 5 years
|
Outcomes are presented separately above apart from adverse events which are presented in the adverse event section
|
up to 5 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 研究主任：Randy Bennett、EMD Serono
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2000年10月1日
初级完成 (实际的)
2008年1月1日
研究完成 (实际的)
2008年9月1日
研究注册日期
首次提交
2005年12月5日
首先提交符合 QC 标准的
2005年12月5日
首次发布 (估计)
2005年12月6日
研究记录更新
最后更新发布 (估计)
2013年11月14日
上次提交的符合 QC 标准的更新
2013年10月21日
最后验证
2013年10月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 24293
- 19-297
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.