NCT00113971终止2 期
A Randomized Phase II Pharmacokinetics/Pharmacodynamics Study of Epratuzumab in Patients With Systemic Lupus Erythematosus
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- UCB Pharma
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- Evaluation of pharmacokinetic samples for epratuzumab levels and evaluation of adverse events, infusion reactions and other safety parameters.
研究概览
简要总结
The goal of this study is to evaluate how epratuzumab is processed by the body (pharmacokinetics) and whether 2 dose levels of epratuzumab are safe and effective in patients with SLE.
详细描述
This study is planned to provide information on how the body processes epratuzumab and how epratuzumab affects the body when epratuzumab is given once weekly for 4 weeks in a row at one of 2 different dose levels. Additional information will be obtained related to the natural variability of disease activity in SLE patients.
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
- •Has SLE by American College of Rheumatology revised criteria (meets >/= 4 criteria)
- •Has had SLE for at least 6 months prior to study entry
- •Has at least one elevated autoantibody level at study entry
- •Has moderately active SLE disease at study entry in any body/organ system (Full criteria not present here due to length of considerations. The protocols should be consulted regarding the complete list of entry criteria.)
排除标准
- •Active Severe Lupus as defined by BILAG Index Level A in any body system or organ
- •Allergy to human antibodies or Murine
- •Prior therapy with other anti-B cell antibodies
结局指标
主要结局
Evaluation of pharmacokinetic samples for epratuzumab levels and evaluation of adverse events, infusion reactions and other safety parameters.
次要结局
- Evaluation of pharmacokinetic samples to assess immunogenicity and evaluation of post-treatment BILAG scores for initial efficacy and disease variability.
研究者
研究点 (5)
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