An Open-Label Re-treatment Trial for Patients Previously Randomized Into the SL0003 and SL0004, Randomized, Double-blind, Placebo-controlled, Multi-center Studies of Epratuzumab in Patients With Systemic Lupus Erythematosus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 29
- 试验地点
- 10
- 主要终点
- Number of subjects reporting at least 1 serious adverse event (SAE) from entry Visit 1 through end of treatment (approximately 6 years)
研究概览
简要总结
Epratuzumab is an investigational antibody designed to help treat Systemic Lupus Erythematosus (SLE). The purpose of the study is to obtain additional long-term information regarding the safety and efficacy of continued maintenance-cycle administrations of Epratuzumab.
详细描述
Due to the logistical considerations, UCB has decided to consolidate the Phase II and Phase III open-label extension trials. Subjects completing this study will be offered the option of continuing to receive epratuzumab through participation in Phase III open-label extension study SL0012 (NCT01408576).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have participated in SL0003 or SL0004 and benefitted from participation in those studies
排除标准
- •Development of toxicity to epratuzumab
- •Significant protocol deviations during the SL0003 or SL0004 studies
- •Evidence of significant infection
结局指标
主要结局
Number of subjects reporting at least 1 serious adverse event (SAE) from entry Visit 1 through end of treatment (approximately 6 years)
时间窗: From Entry Visit 1 through end of treatment (approximately 6 years)
Number of subjects prematurely discontinuing due to a treatment emergent adverse event (TEAE) from entry Visit 1 through end of treatment (approximately 6 years)
时间窗: From Entry Visit 1 through end of treatment (approximately 6 years)
次要结局
- Epratuzumab plasma concentration levels at Week 0(Week 0)
- Time to treatment failure from First Visit through end of treatment (approximately 6 years)(From the first infusion of the first treatment cycle and continuing through end of treatment (approximately 6 years))
- Epratuzumab plasma concentration levels at Week 48(Week 48)
- Epratuzumab plasma concentration levels at Week 96(Week 96)
- Epratuzumab plasma concentration levels at Week 144(Week 144)
- Epratuzumab plasma concentration levels at Week 192(Week 192)
- Epratuzumab plasma concentration levels at Week 240(Week 240)
- Subject Epratuzumab plasma concentration levels at Week 288(Week 288)
- Number of subjects with anti-epratuzumab antibody in plasma at Week 0(Week 0)
- Number of subjects with anti-epratuzumab antibody in plasma at Week 48(Week 48)
- Number of subjects with anti-epratuzumab antibody in plasma at Week 96(Week 96)
- Number of subjects with anti-epratuzumab antibody in plasma at Week 144(Week 144)
- Number of subjects with anti-epratuzumab antibody in plasma at Week 192(Week 192)
- Number of subjects with anti-epratuzumab antibody in plasma at Week 240(Week 240)
- Number of subjects with anti-epratuzumab antibody in plasma at Week 288(Week 288)
- Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Score(Baseline, Last Visit)
- Change from Baseline in Short Form 36-items Health Survey (SF-36) Mental Composite Summary (MCS) Score(Baseline, Last Visit)
- Change from Baseline in Patient's Global Assessment of Disease Activity (PtGADA)(Baseline, Last Visit)
- Change from Baseline in Physician's Global Assessment of Disease Activity (PGADA)(Baseline, Last Visit)