EUCTR2004-004903-39-GB进行中（未招募）1 期
A pilot multi-centre randomised controlled trial of sequential treatment with Mitoxantrone and Glatiramer Acetate vs. Interferon Beta-1a in early active relapsing remitting Multiple Sclerosis. - UNKEMPT
The Walton Centre for Neurology and Neurosurgery0 个研究点目标入组 60 人开始时间: 2005年6月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
入选标准
- •Definite MS as determined by the McDonald criteria (Ann Neurol, July 2001) with relapsing remitting disease course, clinical status should be stable or improving for 1 month prior to screening.
- •Patients 18 to 55 years of age with disease duration less than 5 years from onset, who had 2 relapses in the last 2 years and EDSS 0 – 5.5.
- •At least 3 of the following:
- •a)Patients with three or more relapses in the first two years of disease
- •b)Motor involvement in early relapses (weakness/ataxia)
- •c)Incomplete recovery from early relapses (EDSS >1.5)
- •d)10 or more lesions on T2-weighted brain MRI
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a)Patients ever treated with GA, Mitoxantrone or Interferons.
- •b)Patients treated with IV immunoglobulins (IVIg) in the 4 weeks prior to screening visits.
- •c) Patients treated with methotrexate or azathioprine in the previous 6 monthsprior to screening visits.
- •d) Patients ever treated with cyclophosphamide, Total Lymphoid Irradiation(TLI), or cladribine for injection or anthracenediones or anthracyclines, or prior mediastinal radiotherapy.
- •e) Patients treated with IV or oral steroids within 30 days of screening visit
- •f) Pregnant or lactating women at the screening visit.
- •g) Left ventricular ejection fraction (LVEF) < 50%
- •h) Patients using catheters or Foley catheters.
- •i) Patients who have any other known significant systemic medical disease which may confound the evaluation of the study results such as: amyotrophic lateral sclerosis (ALS), cervical spondylitic myelopathy, syphilis, arteritis, cerebellar syndrome, B12/folate deficiency, lyme disease, human lymphotropic virus, type 1 (HTLV 1)-myelopathy.j) Patients with immune deficiency or other medical condition that would preclude treatment with Mitoxantrone, GA or Interferon.k) Abnormal screening blood tests exceeding any of the limits defined below:
- •· Alanine transaminase (ALT) –twice the upper limit of normal (normal = 5-35 U/L)(may be repeated once)
- •· Aspartate transaminase (AST)-- twice the upper limit of normal (normal = 0-35 U/L)(may be repeated once)
- •· Baseline neutrophil counts of less than 1.5 X109/L
- •· Total white blood cell count less than 2.3 X109/L
- •· Platelet count less than 80 X109/L
- •· Creatinine 60 – 110 µmol/L
- •· Prothrombin time: >150% upper limit of normal (normal = 11.5 – 15.5 secs.)
- •l) Patients with any medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the investigator
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