NCT00203073已完成2 期
A Multi-Center, Randomized, Open Label Study To Evaluate Safety, Tolerability And Efficacy Of Treatment With Mitoxantrone; Pre-Treatment With Glatiramer Acetate (GA) Versus Treatment With GA Alone In Relapsing Forms Of Multiple Sclerosis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Determine if short-term immunosuppression with mitoxantrone (Novantrone®) followed by chronic treatment with Glatiramer Acetate (GA) in comparison to treatment with GA for the same period of time but without immunosuppression is well-tolerated and safe
研究概览
简要总结
It is thought that treating multiple sclerosis with Novantrone for a short period of time prior to treatment with Copaxone may enhance the onset effect of Copaxone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite MS as determined by the McDonald criteria (Ann Neurol, July 2001) with a relapsing disease course.
- •2.EDSS 0.0 - 6.5 inclusive
- •18 to 55 years of age
- •1 or more T1 Gadolinium-enhancing lesions but no more than 15 lesions
- •Able and willing to sign and date an informed consent form
排除标准
- •Patients ever treated with Glatiramer Acetate or Mitoxantrone.
- •Patients treated with interferons or IV immunoglobulins (IV Ig) in the previous 4 weeks prior to screening visits.
- •Patients treated with methotrexate or azathioprine in the previous 6 months prior to screening visits.
- •Patients ever treated with cyclophosphamide or Total Lymphoid Irradiation (TLI), or cladribine for injection or anthracenediones or anthracyclines, or prior mediastinal radiotherapy.
- •Patients treated with intravenous or oral steroids within 28 days prior to initial MRI.
- •Female patients must be non-pregnant, non-lactating, have a negative screening pregnancy test, and must use contraceptive methods deemed reliable by the investigator.
- •Male patients and their partners must use contraceptive methods deemed reliable by the investigator
- •LVEF < 50%
- •Patients using catheters or Foley catheters
- •Patients who have any other known significant systemic medical disease which may confound the evaluation of the study results such as: ALS, cervical spondylitic myelopathy, syphilis, arteritis, cerebellar syndrome (i.e., due to heredodegeneration), B12/folate deficiency, lyme disease, HTLV 1-myelopathy
- •Patients with immune deficiency or other medical condition that would preclude treatment with Mitoxantrone or Glatiramer Acetate
- •Abnormal screening blood tests exceeding any of the limits defined below:
- •Alanine transaminase (ALT) - twice the upper limit of normal Aspartate transaminase (AST) - twice the upper limit of normal Total white blood cell count < 2.3 x 103/uL Baseline neutrophil counts of < 1.5 x103/uL Platelet count < 80 x 103/uL Creatinine >1.5 mg/dL Prothrombin time greater than 150% upper limit of normal
- •Patients with any medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the investigator.
研究组 & 干预措施
Copaxone 20 mg
Active Comparator
Copaxone 20 mg
干预措施: glatiramer acetate 20 mg (Drug)
Copaxone 20mg with Novantrone induction
Active Comparator
Copaxone 20mg with Novantrone induction
干预措施: glatiramer acetate 20 mg, with mitoxantrone (Drug)
结局指标
主要结局
Determine if short-term immunosuppression with mitoxantrone (Novantrone®) followed by chronic treatment with Glatiramer Acetate (GA) in comparison to treatment with GA for the same period of time but without immunosuppression is well-tolerated and safe
时间窗: 15 months
次要结局
未报告次要终点
研究者
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