NCT00718588终止1 期
A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial, With a Single Ascending-Dose Stage Followed by a Multiple Ascending-Dose Stage, of the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous MTRX1011A in Patients With Rheumatoid Arthritis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 66
- 主要终点
- Safety and tolerability of MTRX1011A in both the SAD and MAD stages
研究概览
简要总结
This is a Phase I multicenter study that will be conducted in the United States and consists of a double-blind, placebo-controlled, SAD stage, followed by a double-blind, placebo controlled MAD stage. The study will be conducted in approximately 65 adult patients between 18 and 80 years old who have RA.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RA diagnosed according to the ACR
- •For patients taking anti-rheumatic therapies, receipt of a stable regimen prior to randomization
- •Previous treatment with biologic agents, including anti-TNF agents, permitted but discontinued for an appropriate washout period
- •MAD Stage (same as above with the addition of the following)
- •Failure of at least one biologic agent, defined as lack of or loss of response or intolerance
- •Active disease defined by swollen and tender count
排除标准
- •Significant systemic involvement of RA, including vasculitis, pulmonary fibrosis, or Felty's syndrome
- •Malignancy, or prior malignancy, other than non-melanoma skin cancer or cervical carcinoma in situ that has been resected
- •History of treatment with any T cell-directed therapy
结局指标
主要结局
Safety and tolerability of MTRX1011A in both the SAD and MAD stages
时间窗: Length of study
次要结局
- Characterize the pharmacokinetic response of MTRX1011A(Length of study)
- Characterize the pharmacodynamic profile of single and multiple doses of MTRX1011A(Length of study)
研究者
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