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 400 人开始时间: 2012年11月26日最近更新: 2017年2月20日

适应症

试验速览

暂无简介。

•-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 21 to 35 days apart.
•-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

•-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.
•-History of severe allergic reaction to contrast agents or biological medicines.

发起方

Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)