EUCTR2010-022100-42-HU进行中（未招募）不适用
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2) - ILLUMINATE-2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,140
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
- •[1] Clinical diagnosis of SLE as defined by American College of Rheumatology (ACR) criteria
- •[2] Have positive antinuclear antibodies (ANA)
- •[3] Agree not to become pregnant throughout the course of the trial
- •[4] Have the appropriate Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus (SLE) Disease Activity Index (SELENA-SLEDAI) score at screening
- •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 1026
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 114
排除标准
- •[1] Have active severe Lupus kidney disease
- •[2] Have active Central Nervous System or peripheral neurologic disease
- •[3] Have received intravenous immunoglobulin (IVIg) within 180 days of randomization
- •[4] Have active or recent infection within 30 days of screening
- •[5] Have had a serious infection within 90 days of randomization
- •[6] Have evidence or test positive for Hepatitis B
- •[7] Have Hepatitis C
- •[8] Are human immunodeficiency virus (HIV) positive
- •[9] Have evidence of active or latent tuberculosis (TB)
- •[10] Presence of significant laboratory abnormalities at screening
- •[11] Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization
- •[12] Have received greater than 40 mgs of prednisone or equivalent in the past 30 days
- •[13] Have changed your dose of antimalarial drug in the past 30 days
- •[14] Have changed your dose of immunosuppressive drug in the past 90 days
- •[15] Have previously received rituximab
研究者
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