An Open-Label Long-term Safety Extension Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321 (PEARL-SC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 382
- 试验地点
- 71
- 主要终点
- To assess the long term safety of A-623 in subjects with SLE
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Completed the treatment period specified in study AN-SLE3321 or were enrolled in study AN-SLE3321 prior to November 30, 2010
排除标准
- •Developed a new medical disease or condition that has made the subject unsuitable for this study in the opinion of the Investigator, including interference with written informed consent, study evaluation, completion, and/or procedures
- •Pregnant or nursing
- •Any prior administration of a B-cell modulating therapy other than A-623
- •Received cyclophosphamide, cyclosporine, anti-TNF alpha therapies, transfusion, plasmapheresis or plasma exchange, IV immunoglobulin, or live vaccines according to listed wash-out periods
研究组 & 干预措施
A-623 high dose weekly
High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
干预措施: A-623 (Drug)
A-623 low dose weekly
Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
干预措施: A-623 (Drug)
A-623 high dose every 4 weeks
High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
干预措施: A-623 (Drug)
结局指标
主要结局
To assess the long term safety of A-623 in subjects with SLE
时间窗: Until the drug is approved or the Sponsor discontinues the study
Safety assessments such as AEs, SAEs, vital signs, ECG, clinical chemistry, hematology, and immunogenicity will be analyzed in a descriptive manner and will include infections, malignancies, injection site reactions and immunogenicity, neuropsychiatric events, and deaths
次要结局
未报告次要终点