Cyclophosphamide and Hydroxychloroquine for the Treatment of Severe Thrombocytopenia in Systemic Lupus Erythematosus
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 15
- 主要终点
- complete remission rate
研究概览
简要总结
Treating severe thrombocytopenia is a challenge in the management of systemic lupus erythematosus. Although rheumatologists have followed some rules in real practice,there is very few evidence to support the current treatment algorithm. The purpose of this study is to compare the complete remission rate and partial remission rate of cyclophosphamide and hydroxychloroquine for treating severe thrombocytopenia in Chinese SLE patients.
详细描述
This is a prospective,randomized,open-label,multi-center clinical trial. The aim of this study is to test the efficacy of GC(gluco-corticosteroid)+HCQ(hydroxychloroquine) and GC(glucocorticosteroid)+CTX(cyclophosphamide) with sequential AZA(azathioprine) in the induction and maintenance therapy of severe thrombocytopenia in SLE patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients fulfilled the 1997 ACR modified or SLICC classification criteria of SLE；
- •New onset thrombocytopenia: platelet count <30X109/L(by both routine test and citric acid anti-coagulated blood count test) within 3 months
排除标准
- •Thrombocytopenia caused by other reasons, including drugs；
- •Positive for active HAV(hepatitis A virus)/HBV(hepatitis B virus) infection
- •Active HIV(human immunodeficiency virus) or HCV(hepatitis C virus) infection;
- •Active HP(Helicopter pylori) infection;
- •Severe liver and kidney dysfunction；
- •Severe neuropsychiatric lupus；
- •No response to high dose steroid and/or cyclophosphamide 1 month prior to study enrollment；
- •Uncontrolled diabetes or hypertension before entry
- •Active GI bleeding 3 months before entry
- •Intolerant to HCQ in the past treatment history；
- •Severe bone marrow suppression or liver damage caused by cyclophosphamide in the past history；
- •Active infection , including bacteria, virus, fungi, mycobacteria
- •Allergy to any of the study medications
- •Confirmed TTP(thrombolic thrombocytopenic purpura)or CAPS(catastrophic anti-phosphilipid syndrome)
- •Platelet count less than 20X109/L with active bleeding
- •Myelodysplastic diseases
- •Patients with heart and lung function impairment
- •thiopurine S-methyltransferase (TPMT) gene positive -
研究组 & 干预措施
Group1:Hydroxychloroquine
Hydroxychloroquine: 100 mg tablets by mouth, 400mg everyday for 12 months Methylprednisolone: 4 mg tablets by mouth, 40-50mg everyday and tapering for 12 months
干预措施: Hydroxychloroquine (Drug)
Group1:Hydroxychloroquine
Hydroxychloroquine: 100 mg tablets by mouth, 400mg everyday for 12 months Methylprednisolone: 4 mg tablets by mouth, 40-50mg everyday and tapering for 12 months
干预措施: Methylprednisolone (Drug)
Group 2:Cyclophosphamide
Cyclophosphamide, Azathioprine & Methylprednisolone Cyclophosphamide: 200mg powder intravenous infusion, 1000mg every month for 6 month.
Azathioprine: 100 mg tablets by mouth, everyday for 6 months. Methylprednisolone: 4 mg tablets by mouth, 40-50mg everyday and tapering for 12 months
干预措施: Hydroxychloroquine (Drug)
Group 2:Cyclophosphamide
Cyclophosphamide, Azathioprine & Methylprednisolone Cyclophosphamide: 200mg powder intravenous infusion, 1000mg every month for 6 month.
Azathioprine: 100 mg tablets by mouth, everyday for 6 months. Methylprednisolone: 4 mg tablets by mouth, 40-50mg everyday and tapering for 12 months
干预措施: Cyclophosphamide (Drug)
Group 2:Cyclophosphamide
Cyclophosphamide, Azathioprine & Methylprednisolone Cyclophosphamide: 200mg powder intravenous infusion, 1000mg every month for 6 month.
Azathioprine: 100 mg tablets by mouth, everyday for 6 months. Methylprednisolone: 4 mg tablets by mouth, 40-50mg everyday and tapering for 12 months
干预措施: Azathioprine (Drug)
Group 2:Cyclophosphamide
Cyclophosphamide, Azathioprine & Methylprednisolone Cyclophosphamide: 200mg powder intravenous infusion, 1000mg every month for 6 month.
Azathioprine: 100 mg tablets by mouth, everyday for 6 months. Methylprednisolone: 4 mg tablets by mouth, 40-50mg everyday and tapering for 12 months
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
complete remission rate
时间窗: at 12 month
percentage of patients whose platelet count \> 100X109/L
次要结局
- partial remission rate(at 12 month)