NCT01123070已完成1 期
A Phase Ib Study Evaluating Safety, Pharmacokinetic and Pharmacodynamic Profiles of a Single Course of TL011 Infusions in Subjects With Severe, Active Rheumatoid Arthritis
Teva Pharmaceutical Industries, Ltd.36 个研究点 分布在 5 个国家目标入组 54 人开始时间: 2010年2月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 36
- 主要终点
- Area Under the Plasma Concentration Versus Time Curve [AUC(0-t)] in Part B
研究概览
简要总结
The purpose of this study is to determine the safety and pharmacology of TL011 in patients with severe rheumatoid arthritis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects
- •Rheumatoid arthritis as defined by the 1987 ACR Classification
- •Severe active seropositive disease
- •Inadequate response or intolerance to other DMARDs
- •Treatment with MTX
排除标准
- •Rheumatic autoimmune disease other than RA
- •Active infection
- •Known immunodeficiency syndrome
- •Positive Hepatitis B surface antigen or antibodies to Hepatitis C
- •History of cancer
结局指标
主要结局
Area Under the Plasma Concentration Versus Time Curve [AUC(0-t)] in Part B
时间窗: Day 1 to Day 57
次要结局
- Number of Participants With Adverse Events in Part B(From randomization up to Week 24)
- Cmax Post First Dose (C1max) and Post Second Dose (C2max) in Part B(Day 1, Day 15)
- Maximum Observed Concentration (Cmax) in Part B(Day 1 to Day 57)
- AUC At First Dose (AUC1) and AUC At Second Dose (AUC2) in Part B(Day 1, Day 15)
- Number of Participants With American College of Rheumatology (ACR20) Criteria Response in Part B(Baseline to Day 57)
- Area Under the Plasma Concentration Versus Time Curve [AUC (0-t)] for Part A Cohort 2(Day 1 to Day 57)
- Percent Change From Baseline in CD19+ B-cell Count in Part B(Baseline to Day 57)
- Number of Participants With Adverse Events in Part A(From randomization up to Week 24)
研究者
研究点 (36)
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