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 INC0 个研究点目标入组 400 人开始时间: 2013年1月14日最近更新: 2016年4月11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: 0
•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.

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