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临床试验/NCT00293072
NCT00293072已完成2 期

Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis Resistant to Conventional Therapy

Cambridge University Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2002年3月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
20
试验地点
2
主要终点
1. Clinical remission at 6 or 12 months

研究概览

简要总结

Lupus and vasculitis are autoimmune conditions which can be life threatening. In order to treat these conditions toxic therapies such as cyclophosphamide and steroids are often required. These standard treatments are associated with significant side effects. Furthermore a proportion of patient do not respond to these conventional therapies. Newer safer therapies are being sought. Rituximab is a drug that eliminates B cell from the blood. B cells are one part of the human immune system that helps prevent infections. Abnormal activity of the immune system is responsible for autoimmune disease although the exact mechanisms in lupus and vasculitis are not yet established. Rituximab is liscenced as a treatment for a form of B cell cancer called non-Hodgkins Lymphoma and has a good safety track record when used in this context. It has recently been used to treat some autoimmune conditions with positive results. In this pilot study we wish to assess the effectiveness and safety of rituximab in patients with lupus and vascultis that are resistant to conventional therpies.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of SLE or ANCA associated vasculitis
  • Active disease refractory to 6 months conventional therapy with cyclophosphamide, prednisolone and at least one other immunosupressive agent ( or a lesser period if this therapy cannot be tolerated)

排除标准

  • HbeAg or HCV Ab positive or known HIV positivity ( HIV testing not necessary for this study)
  • Pregnancy, inadequate contraception or lactation
  • Current enrolment in pother clinicla trials -

结局指标

主要结局

1. Clinical remission at 6 or 12 months

2. Absence of a severe life threatening adverse event

次要结局

未报告次要终点

研究者

研究点 (2)

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