NCT01598857撤回2 期
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel Vasculitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Induction of clinical remission
研究概览
简要总结
The purpose of this study is to evaluate efficacy, safety and tolerability of blisibimod when taken with methotrexate in the induction of remission in ANCA-Associated Small Vessel Vasculitis.
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
- Double (Participant, Investigator)
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
- •18 years of age or older (male or female).
- •Granulomatosis with polyangiitis (GPA, or Wegener's granulomatosis) or microscopic polyangiitis (MPA) according to the definitions of the American College of Rheumatology and Chapel Hill Consensus Conference.
- •Active GPA or MPA disease at screening.
- •Positive for either PR3-ANCA or MPO-ANCA at screening.
- •Subject willing to initiate corticosteroids and methotrexate (MTX) if not already on corticosteroids and/or MTX at baseline.
- •Clinical intention to prescribe MTX therapy for treatment of GPA or MPA.
排除标准
- •Diagnosed with Churg Strauss syndrome.
- •Severe GPA or MPA disease that would conventionally be treated with cyclophosphamide.
- •Nursing or pregnant.
- •Active systemic infection or deep-space infection.
- •Active hepatitis B, active hepatitis C or a documented history of HIV, hepatitis B, or hepatitis C.
- •Liver disease.
- •History of documented anti-glomerular basement membrane (GBM) disease.
- •Malignancy within the past 5 years.
- •History of active tuberculosis (TB) or history of TB infection.
- •Anemia, neutropenia, or thrombocytopenia.
- •Serum creatinine level greater than 2.5 mg/dL.
- •Prior administration of a B-cell modulating therapy other than rituximab.
- •Subject has not yet completed at least 3 months or 5 half-lives (whichever is longer) since ending other investigational study.
- •History of congenital immunodeficiency.
研究组 & 干预措施
Blisibimod
Experimental
干预措施: Blisibimod (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Induction of clinical remission
时间窗: 24 weeks
Clinical remission includes the ability to taper corticosteroids.
次要结局
- Time to treatment failure(Various timepoints to 24 weeks)
- Ability to taper corticosteroids(Various timepoints to 24 weeks)
- Change in baseline BVAS/WG score(Various timepoints to 24 weeks)
- Safety profile(Various timepoints to 24 weeks)
- Compare biomarker changes from baseline(Various timepoints to 24 weeks)
- Time to complete remission(Various timepoints to 24 weeks)
研究者
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