An Open, Non-randomised Pilot Study of Anti-TNF-alpha Therapy in Early or Progressing HAM/TSP
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Incidence of clinical failure
研究概览
简要总结
An open-label, non-randomised, uncontrolled, proof-of-concept study of eight patients with 'definite' HTLV-I-associated myelopathy/Tropical Spastic Paraparesis (HAM/TSP). Eligible patients will have either early disease (of less than 2 years duration) or progressive disease (with observed clinical deterioration during the preceding 3 months.
Following 2 baseline assessments including Magnetic Resonance Imaging (MRI) of the spinal cord and a lumbar puncture for examination of the fluid around the brain (CSF) participants will be treated with a total of 7 infusions of the anti-TNF-alpha antibody infliximab over a period of 48 weeks. After the last on therapy assessment at 48 weeks participants will be followed up for a further 24 weeks. Study assessments will be clinical, virological, immunological and radiological. MRIs of the spinal cord will be obtained at weeks 12 and 72. CSF will be examined, on therapy, at week 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are able to give informed consent
- •Are 16 years or older
- •Have 'definite' HAM/TSP according to the criteria of "Definite HAM/TSP" agreed in Belem 200361
- •Have early or progressing disease as defined here:
- •"Early HAM/TSP": Patients must have motor disability (minimum of stiffness or weakness) for less than 2 years. (Bladder symptoms if the original and only presenting symptoms as assessed by history are not included)
- •"Progressing HAM/TSP"
- •New or worsening motor symptoms in a patient with definite HAM of > 2 years duration within the last 3 months
排除标准
- •Hepatitis B or hepatitis C infection
- •HIV infection
- •Overt sepsis, abscesses or opportunistic infections
- •Active TB (untreated or on treatment)
- •Strongyloides stercoralis (untreated)
- •Known hypersensitivity to inflixmab, other murine proteins or to any of the excipients
- •Malignancy
- •Moderate or severe heart failure (NYHA class III/IV)
- •Pregnancy or breastfeeding
- •Unhealed surgical wounds
- •Planned impending surgery - treatment would be withheld for 2-4 weeks prior to major surgery and started/restarted post-operatively if no evidence of infection and wound healing is satisfactory
- •Current immunosuppressive or immunomodulatory therapy
研究组 & 干预措施
Infliximab
Infliximab 3mg/kg infused intravenously at weeks 0, 2 and 8 and then every 8 weeks until and including week 40 of the study
干预措施: Infliximab (Drug)
结局指标
主要结局
Incidence of clinical failure
时间窗: 48 weeks
次要结局
- Change in timed 10m walk(12, 24, 48 and 72 weeks)
- Clinical Safety(48 weeks)
- HTLV-I viral load in CSF(12 weeks)
- HTLV-I viral load in peripheral blood(12, 24, 48 and 72 weeks)
- % CD4+ T- lymphocytes expressing CD25(24, 48 and 72 hours)
研究者
Graham Taylor
Reader in Communicable Diseases
Imperial College London