A Single Center, Randomized, Placebo-Controlled, Double Blind, Parallel Group Study to Evaluate the Tolerability of a Single Dose of Abatacept 30 mg/kg Via Intravenous Infusion in Chinese SLE Subjects With Lupus Nephritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs
研究概览
简要总结
The purpose of this study is to determine whether abatacept at a dose 30 mg/kg via intravenous infusion is safe and well tolerated in the treatment of lupus nephritis in mainland Chinese subjects with systemic lupus erythematosus (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
- Double (Participant, Investigator)
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
- •Men and women, at least 18 years of age, with a diagnosis of systemic lupus erythematosus (SLE) and with lupus nephritis currently stable for the last 3 months without change in treatment for lupus nephritis
- •Stable renal disease
- •No flaring of other organ systems in a minimum of the last 3 months
排除标准
- •Unstable lupus nephritis and serum creatinine >3 mg/dL
- •Progressive renal failure, end stage renal disease, or renal transplant requiring continuous dialysis
- •Severe unstable, refractory, or progressive SLE
- •History of cancer
- •Participants at risk for tuberculosis
- •Autoimmune disease other than SLE as main diagnosis
- •Human immunodeficiency virus or herpes zoster infection
- •Hepatitis-B surface antigen-positive or hepatitis C antibody-positive participants
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Abatacept, 30 mg/kg
干预措施: Abatacept (Drug)
Abatacept, 10 mg/kg
Open-label long-term extension phase
干预措施: Abatacept (Drug)
结局指标
主要结局
Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs
时间窗: From Day 1 of double-blind period to 1st dose of long-term period
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Short-term Period: Number of Adverse Events (AEs) Related to Study Drug
时间窗: From Day 1 of double-blind period to 1st dose of long-term period
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. Intensity = mild (grade 1), moderate (grade 2), severe (grade 3), life-threatening/disabling (grade 4).
Short-term Period: MeanSystolic and Diastolic Blood Pressure
时间窗: Day 1 predose and postdose and Day 2
Vital sign measurements are summarized without regard to position (sitting, standing, supine).
Short-term Period: Mean Heart Rate
时间窗: Day 1 predose and postdose and Day 2
Vital signs measurements are summarized without regard to position (sitting, standing, supine).
Short-term Period: Mean Respirations Rate
时间窗: Day 1 predose and postdose and Day 2
Vital sign measurements are summarized without regard to position (sitting, standing, supine).
Short-term Period: Mean Temperature
时间窗: Day 1 predose and postdose and Day 2
Vital sign measurements are summarized without regard to position (sitting, standing, supine).
Short-term Period: Number of Participants With Clinical Laboratory and Electrocardiogram (ECG) Abnormalities
时间窗: Screening and Days 1 and 2
Laboratory tests consisted of complete blood count, chemistry, and urinalysis.
次要结局
- Long-term Period: Number of Participants With Death as Outcome, Serious AEs (SAEs), Discontinuations Due to AEs, and Treatment-related AEs(Days 15 to 56 days post last dose of the long-term period)
- Minimum (Cmin) Plasma Concentration of Abatacept(Days 15, 29, 85, 169, 253 and 337)
- Maximum (Cmax) Plasma Concentration of Abatacept(Postdosing Day 1)
- Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests(Days 15 to 56 days post last dose of the long-term period)
- Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)(Days 15 to 56 days post last dose of the long-term period)
- Long-term Period: Number of Participants With Abatacept-specific Antibodies(Day15 to 56 days post last dose of the long-term period)