Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 509
- 试验地点
- 1
- 主要终点
- Congestive Heart Failure (Annual Follow-Up Phase)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Congestive Heart Failure (Annual Follow-Up Phase)
时间窗: up to 5 years
Number of patients experiencing congestive heart failure during the annual follow-up phase of the trial
Left Ventricular Ejection Fraction (Annual Follow-Up Phase)
时间窗: 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
Serious Infections (Treatment Phase)
时间窗: up to 36 months
Number of serious infections during the treatment phase of the trial
Congestive Heart Failure (Treatment Phase)
时间窗: up to 36 months
Number of patients experiencing congestive heart failure during the treatment phase of the trial
IV Antibiotics (Individual Drugs Unspecified) Utilized Due to Serious Infection (Treatment Phase)
时间窗: up to 36 months
Number of subjects in whom IV antibiotics were utilized due to serious infection during the treatment phase
Left Ventricular Ejection Fraction (Treatment Phase)
时间窗: 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
IV Antibiotics (Individual Drugs Unspecified) Utilized Due To Serious Infection (Annual Follow-Up Phase)
时间窗: up to 5 years
Number of subjects in whom IV antibiotics were utilized due to serious infection during the annual follow-up phase
Severe Neutropenia (Annual Follow-Up Phase)
时间窗: up to 5 years
Number of infections associated with severe neutropenia at onset during the annual follow-up phase
Clinical Relapses (Treatment Phase)
时间窗: up to 36 months
Number of clinical relapses reported during the treatment phase of the trial
Clinical Relapses (Annual Follow-Up Phase)
时间窗: up to 5 years
Number of clinical relapses reported during the annual follow-up phase of the trial
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
时间窗: up to 5 years
Outcomes are presented separately above apart from adverse events which are presented in the adverse event section
Serious Infections (Annual Follow-Up Phase)
时间窗: up to 5 years
Number of serious infections during the annual follow-up phase of the trial
Severe Neutropenia (Treatment Phase)
时间窗: up to 36 months
Number of infections associated with severe neutropenia at onset during the treatment phase
次要结局
未报告次要终点