EUCTR2011-004569-33-GB进行中（未招募）1 期
A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener’s Granulomatosis and Microscopic Polyangiitis - BREVAS
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)0 个研究点目标入组 106 人开始时间: 2012年11月8日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 106
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Clinical diagnosis Wegener's granulomatosis or microscopic polyangiitis by Chapel Hill criteria.
- •Disease flare in the past 26 weeks requiring treatment with high dose corticosteroids and 1 of the following medications: rituximab, oral cyclophosphamide OR IV cyclophosphamide.
- •Tested positive for anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase (anti-MPO) antibodies at any time prior to enrollment.
- •Achieve remission no more than 26 weeks after first dose of induction treatment. Remission is defined as a Birmingham Vasculitis Activity (BVAS) score of 0 and receiving less than 10 mg/day of oral prednisone (or equivalent) on 2 consecutive visits 14 days apart, between 6 and 26 weeks after the first dose of induction therapy.
- •Maintenance therapy on this study must start no more than 2 weeks after confirmation of remission.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 320
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •Pregnant or nursing.
- •Receipt of a B cell targeted therapy (other than rituximab) at anytime
- •Receipt of an investigational biological agent within the 60 days.
- •Required management of acute or chronic infections within the past 60 days.
- •Current drug or alcohol abuse or dependence.
- •Current or past positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C or abnormal liver function tests.
- •History of severe allergic reaction to contrast agents or biological medicines.
研究者
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