Short-Course Glucocorticoids and Rituximab in ANCA-Associated Vasculitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Complete Remission
研究概览
简要总结
The purpose of this pilot study is to test whether an 8-week course of glucocorticoids, combined with rituximab, is effective in treating ANCA-associated vasculitis.
详细描述
The primary aim of this pilot study is to examine whether an 8 week course of glucocorticoids, in combination with rituximab, is effective in inducing and maintaining disease remission for up to 6 months in a subset of patients with ANCA-associated vasculitis (AAV) who have a more favorable prognosis.
This pilot study will enroll 20 patients with active AAV. Close patient follow-up will insure that any patients who require courses of glucocorticoids longer than two months will receive longer therapy, if appropriate for their well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ages 18-85 years old
- •Diagnosis of GPA or MPA according to the definitions of the Chapel Hill Consensus Conference
- •New diagnosis or disease flare with a Birmingham Vasculitis Activity Score/Wegener's granulomatosis (BVAS/WG) of > 3
排除标准
- •Renal disease in patients with PR3-ANCA as defined by any of the following:
- •Urinary red blood cell casts
- •Biopsy-proven glomerulonephritis
- •Increase in serum creatinine of >30% over baseline
- •Severe renal disease in patients with MPO-ANCA as defined by both of the following:
- •Urinary red blood cell casts or biopsy-proven glomerulonephritis
- •Estimated glomerular filtration rate < 30 ml/min/1.73m2
- •Diffuse alveolar hemorrhage requiring ventilatory support
- •GC treatment for longer than 14 days prior to enrollment unless patient has been on a stable maintenance dose of prednisone at the time of the flare
- •Daily oral cyclophosphamide within 1 month prior to enrollment
- •Completed a remission induction course of cyclophosphamide or rituximab within 4 months of enrollment
- •Hepatitis B infection
- •HIV infection
- •History of anti-GBM disease
- •Other uncontrolled disease, including drug and alcohol abuse, that may interfere with the study
- •Pregnancy or breastfeeding
- •History of severe allergic reactions to human or chimeric monoclonal antibodies
研究组 & 干预措施
Glucocorticoids and Rituximab
This is a single-arm trial. All patients receive both rituximab and glucocorticoids. The protocol calls for the discontinuation of prednisone within two months of the baseline visit.
干预措施: Glucocorticoids (Drug)
Glucocorticoids and Rituximab
This is a single-arm trial. All patients receive both rituximab and glucocorticoids. The protocol calls for the discontinuation of prednisone within two months of the baseline visit.
干预措施: Rituximab (Drug)
结局指标
主要结局
Complete Remission
时间窗: 6 months
We examined whether an 8-week glucocorticoid course in combination with rituximab (RTX) would induce disease remission in patients with AAV. The primary outcome was disease remission off steroids at 6 months.
次要结局
- Sustained Complete Remission(6 months)
- Limited Flares(6 months)
- Disease Response(4 weeks)
- Early Treatment Failures(4 weeks)
- Partial Remission(8 weeks)
- Vasculitis Damage Index (VDI)(24 months)
- Severe Flares(6 months)
研究者
Stone, John H, M.D., M.P.H
Professor of Medicine
Massachusetts General Hospital