EUCTR2011-004296-36-BG进行中（未招募）1 期
A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects with Systemic Lupus Erythematosus
MedImmune, LLC,0 个研究点目标入组 300 人开始时间: 2013年3月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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
- 性别
- All
入选标准
- •Fulfills at least 4 of the 11 American College of Rheumatology (ACR) criteria for systemic lupus erythematosus (SLE) including a positive antinuclear antibody (ANA) greater than or equal to 1:80 or elevated anti-double-stranded DNA or anti-Smith antibody at screening
- •Pediatric or adult SLE with chronic disease activity for greater than or equal to 24 weeks
- •Weight greater than or equal to 40 kg
- •Currently receiving stable dose of oral prednisone (or equivalent) less than or equal to 40 mg/day and/or antimalarials/immunosuppressives
- •Active moderate to severe SLE disease based on SLE disease activity score (SLEDAI) and British Isles Lupus Assessment Group Index (BILAG) and Physicians Global Assessment
- •No evidence of cervical malignancy on Pap smear within 2 years of randomization
- •Female subjects must be willing to avoid pregnancy
- •Negative tuberculosis (TB) test or newly positive TB test due to latent TB for which treatment must be initiated at or before randomization
- •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 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Active severe SLE-driven renal disease or unstable renal disease prior to screening
- •Active severe or unstable neuropsychiatric SLE
- •Clinically significant active infection including ongoing and chronic infections
- •History of human immunodeficiency virus (HIV)
- •Confirmed Positive tests for hepatitis B or positive test for hepatitis C
- •History of severe herpes infection such as herpes encephalitis, ophthalmic herpes, disseminated herpes
- •Live or attenuated vaccine within 4 weeks prior to screening
- •Subjects with significant hematologic abnormalities
研究者
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