NCT02499315终止1 期
A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 357 in Female Subjects With Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- The number of subjects reporting of treatment-emergent adverse events or clinically significant changes in physical examinations, vital signs, laboratory safety tests, and ECGs
研究概览
简要总结
The purpose of the study is to find out if AMG 357 is safe and tolerated by women with Rhematoid 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
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject provided informed consent.
- •Rheumatoid arthritis present for ≥ 3 months.
- •Global functional class I, II, or III.
- •History of or positive for, Rheumatoid Arthritis
- •Taking methotrexate consecutively for ≥ 12 weeks and on a stable dose at 10-25 mg weekly.
- •Subjects currently taking NSAIDs or oral corticosteroids.
- •Normal ECG values
- •Immunizations up to date.
排除标准
- •Positive Hepatitis B, Hepatitis C, Positive HIV
- •Sensitivity to any of the products or components to be administered.
- •Malignancy within 3 years
- •Presence of recurrent or chronic infections
- •Evidence of infections within the 30 days prior to randomization
- •Presence of a serious infection
- •Prosthetic joint infection within 3 years or native joint infection within 1 year
- •History of exposure to tuberculosis without a history of prophylactic treatment
- •Class IV RA.
- •Felty's syndrome
- •Chronic pelvic pain or hemorrhagic ovarian cyst within 3 years
- •Any bleeding disorder that is clinically significant
- •Low white blood cell or neutrophil count
- •Elevated serum creatinine clearance
- •Low hemoglobin and platelet count
- •Received live vaccines within 3 months of first dose
- •Alcohol and/or substance abuse within past 12 months
- •Blood donation within 60 days
- •Positive urine screen for drugs of abuse
- •Any prior use of rituximab in the last 6 months (or other B cell depleting agents) and CD19 levels < lower limits of normal
- •Use of a weekly or bimonthly biologic within 2 weeks or monthly biologic agents within 4 weeks
- •Corticosteroid injections for acute RA flare within 4 weeks
- •Grapefruit juice or grapefruit containing products within 7 days of first dose.
- •All herbal medicines, vitamins, and supplements within the 30 days
- •The use of any experimental/investigational biologic DMARD unless off agent for 3 months; or off for 6 months for B cell depleting agents
- •Known GI disease or GI procedures
- •Women of reproductive potential who are unwilling to practice birth control
- •Women who are pregnant/lactating/breastfeeding
- •Subject with IgG levels < lower limit of normal at screening
研究组 & 干预措施
AMG 357
Experimental
干预措施: AMG 357 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The number of subjects reporting of treatment-emergent adverse events or clinically significant changes in physical examinations, vital signs, laboratory safety tests, and ECGs
时间窗: 1 year
次要结局
- AMG 357 pharmacokinetic profile (eg, plasma concentration, maximum observed concentration [Cmax], time at Cmax [Tmax], and area under the concentration-time curve [AUC])(1 year)
研究者
研究点 (1)
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