A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab

HUMAN GENOME SCIENCES INC0 个研究点目标入组 4,018 人开始时间: 2013年1月14日最近更新: 2022年8月8日

研究概览

暂无简介。

•Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria. • Active SLE disease. • Autoantibody-positive. • On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate).
•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 4500
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 500

•Pregnant or nursing. • Have received treatment with any of the following: belimumab, either as a marketed product or as an investigational agent; any B cell targeted therapy (for example, rituximab) in the past year; or any biological agent (for example, adalimumab, etanercept, infliximab, or anakinra) in the past 90 days. • Have received a live vaccine within the past 30 days. • Have severe active lupus kidney disease. • Have severe active central nervous system (CNS) lupus. • Current or past positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.

发起方