JPRN-UMIN000014222已完成4 期
ow-dose glucocorticoids plus rituximab versus high-dose glucocorticoids plus rituximab for remission induction in ANCA-associated vasculitis; a multicentre, open label, randomised control trial - LoVAS
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
研究概览
简要总结
Remission rates: Low-dose group 71% vs High-dose group 69%
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •The presence of any of the following will preclude patient inclusion: (1) Prior treatment for ANCA-associated vasculitis before trial entry (2) ANCA-associated vasculitis related glomerulonephritis (eGFR<15ml/min) or alveolar hemorrhage (oxygen inhalation >2L/min) (3) Presence of another multisystem autoimmune disease (4) Known infection with HIV; a past or current history of hepatitis B virus or hepatitis C virus infection (5) Desire to bear children, pregnancy or lactating (6) History of malignancy within the past 5 years or any evidence of persistent malignancy (7) Ongoing or recent (last 1 year) evidence of active tuberculosis (8) Severe allergy or anaphylaxis to monoclonal antibody therapy (9) Any concomitant condition anticipated to likely require oral systemic glucocorticoids, immunosuppressants, biologics, plasma exchange or IVIg (10) Any biological B cell depleting agent (such as rituximab or belimumab) within the past 6 months (11) Other conditions, in the investigator's opinion, inappropriate for the trial entry
研究者
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