NCT01414101已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ISIS 329993 in Subjects With Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ISIS CRP Rx and its effects on CRP and other pharmacodynamic measures, versus placebo, in subjects with active 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female; age 18 to 75 years
- •Active RA for at least 6 months
- •Active disease defined by having equal to or greater than 6 swollen joints and 6 tender joints, based on a 28 joint count
- •On stable doses and regimen of allowed RA medications
- •Currently receiving at least 10 mg of methotrexate a week. Patients unable to tolerate doses greater than 10 mg may also be eligible for enrollment.
排除标准
- •Diagnosis of Felty's syndrome, psoriatic arthritis, gout, or auto-immune rheumatic disease
- •Any surgical procedure within 30 days of Screening or likely to need joint or tendon surgery or other surgical procedure during the study
- •Intra-articular or intra-muscular corticosteroids within 60 days prior to dosing
- •Previous treatment with any biologic response modifying agent for RA within 90 days or 5 half-lives, whichever is greater, prior to screening
- •Previous treatment with rituximab at any time
- •Use of corticosteroid therapy equivalent to an average daily dose of >10 mg of prednisone
- •Any Screening laboratory values that are out of allowed reference ranges
- •Inability to comply with protocol or study procedures
- •Any other significant illness or condition that may adversely affect the subjects participation in the study
研究组 & 干预措施
Group A
Experimental
Dose 1 ISIS CRP Rx versus Placebo
干预措施: ISIS CRP Rx or Placebo (Drug)
Group B
Experimental
Dose 2 ISIS CRP Rx versus Placebo
干预措施: ISIS CRP Rx or Placebo (Drug)
Group C
Experimental
Dose 3 ISIS CRP Rx versus Placebo
干预措施: ISIS CRP Rx or Placebo (Drug)
结局指标
主要结局
Safety
时间窗: 155 Days
Adverse events, laboratory tests, and vital signs
次要结局
- hsCRP(155 Days)
研究者
研究点 (2)
Loading locations...
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