Rituximab Therapy for the Patients With HTLV-1-associated Myelopathy
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The improvement of pyramidal or bowel-bladder function score in EDSS during 12 month treatment
研究概览
简要总结
Neuroprotective or anti-inflammatory strategies are invaluable in HTLV-1-associated myelopathy due to its rapid progression. We evaluated the efficacy of rituximab in patients with HTLV-1-associated myelopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Patients HTLV-1-associated myelopathy (tropical spastic paraparesis)
排除标准
- •Anticipated survival of at least 3 years
- •Inability to undergo neuroimaging with Magnetic Resonance
- •Clinically significant hepatic disease as demonstrated by history, clinical exam (ascites, varices), or laboratory findings (LFTs >2x normal, coagulopathy as described)
- •Comorbid conditions likely to complicate therapy including but not limited to the following: a history of New York Heart Association class II, III, or IV Congestive Heart Failure; end-stage acquired immune deficiency syndrome
- •Pregnancy
- •Malignancy (history of or active)
- •Concomitant use with antineoplastic, immunosuppressive or immune modulating therapies
研究组 & 干预措施
Rituximab group
Rituximab will be administered as 100 mg IV, once per week for 3 consecutive weeks. Continued dosage was dependent on the percentage of circulating CD19 B-cell counts from patients . Whenever it reached 1% of total lymphocyte population, rituximab 100 mg was reinfused
干预措施: Rituximab (Drug)
结局指标
主要结局
The improvement of pyramidal or bowel-bladder function score in EDSS during 12 month treatment
时间窗: up to 360 days
EDSS include the evaluated on visual, brainstem, pyramidal, cerebellar, sensory, bowel-bladder and cerebral functions
次要结局
- Change in immunology function(up to 360 days)
研究者
Wan-Jin Chen
Neurology department
First Affiliated Hospital of Fujian Medical University