Phase II Pilot Cohort Study to Investigate the Safety and Efficacy of Infliximab as Additional Therapy in the Treatment if Anti-Neutrophil Cytoplasm Antibody Associated Vasculitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Time to clinical remission (Birmingham Vasculitis Activity Score 0 or 1)
研究概览
简要总结
The purpose of this study is to determine whether Infliximab (monoclonal anti-tumour necrosis factor alpha antibodies) are safe and effective in the treatment of anti-neutrophil cytoplasm antibody (ANCA) associated vasculitis.
详细描述
Anti-neutrophil cytoplasm antibody (ANCA) associated vasculitis is a life-threatening systemic inflammatory autoimmune disease. Current treatment regimes using corticosteroids and cyclophosphamide have improved patient survival but are associated with treatment associated morbidity and mortality. Tumour necrosis factor alpha (TNF) is a proinflammatory cytokine which has been implicated in the pathogenesis of ANCA vasculitis. Anti-TNF therapies have been used successfully in the management of other inflammatory autoimmune diseases. This phase II cohort study has been designed to investigate the safety and efficacy of anti-TNF monoclonal antibody (Infliximab) therapy for patients with ANCA associated vasculitis when used in addition to standard immunosuppressive therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Either newly diagnosed or relapsed ANCA associated vasculitis (Wegener's granulomatosis, microscopic polyangiitis, renal limited vasculitis)
排除标准
- •Active infection
- •Malignancy
- •Pregnancy
- •Diagnosis of Churg-Strauss syndrome or anti-glomerular basement membrane antibody disease
研究组 & 干预措施
1
Patients with active vasculitis who receive infliximab in addition to standard immunosuppressive therapy
干预措施: Infliximab (Biological)
1
Patients with active vasculitis who receive infliximab in addition to standard immunosuppressive therapy
干预措施: Cyclophosphamide (Drug)
1
Patients with active vasculitis who receive infliximab in addition to standard immunosuppressive therapy
干预措施: Prednisolone (Drug)
1
Patients with active vasculitis who receive infliximab in addition to standard immunosuppressive therapy
干预措施: Azathioprine (Drug)
1
Patients with active vasculitis who receive infliximab in addition to standard immunosuppressive therapy
干预措施: Mycophenolate mofetil (Drug)
1
Patients with active vasculitis who receive infliximab in addition to standard immunosuppressive therapy
干预措施: Methylprednisolone (Drug)
2
Patients with active ANCA associated vasculitis who receive standard immunosuppression but no infliximab
干预措施: Cyclophosphamide (Drug)
2
Patients with active ANCA associated vasculitis who receive standard immunosuppression but no infliximab
干预措施: Prednisolone (Drug)
2
Patients with active ANCA associated vasculitis who receive standard immunosuppression but no infliximab
干预措施: Azathioprine (Drug)
2
Patients with active ANCA associated vasculitis who receive standard immunosuppression but no infliximab
干预措施: Plasma exchange (Procedure)
2
Patients with active ANCA associated vasculitis who receive standard immunosuppression but no infliximab
干预措施: Mycophenolate mofetil (Drug)
2
Patients with active ANCA associated vasculitis who receive standard immunosuppression but no infliximab
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
Time to clinical remission (Birmingham Vasculitis Activity Score 0 or 1)
时间窗: 0, 6, 10, 14, 26, 39 and 52 weeks
次要结局
- Adverse events(Weeks 2, 6, 10, 14, 26, 39, 52)
- Vasculitis Damage Index Score(Weeks 0, 14, 26, 39, 52)
- Renal function(Weeks 0, 2, 6, 10, 14, 26, 39, 52)