NCT00279760已完成1 期
A Pilot, Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Preliminary Clinical Activity and Immunogenicity of Multiple Doses of LEA29Y and CTLA4Ig Administered Intravenously to Subjects With Rheumatoid Arthritis
Bristol-Myers Squibb61 个研究点 分布在 6 个国家目标入组 210 人开始时间: 2006年1月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 61
- 主要终点
- Assess the relative safety and preliminary efficacy (clinical activity) of BMS-188667 and BMS-224818 in subjects with rheumatoid arthritis (RA)
研究概览
简要总结
This randomized, double-blind, placebo controlled, parallel and multiple dose study provided safety, preliminary efficacy, and immunogenicity information about the use of BMS-188667 and BMS-224818 in subjects with 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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RA < 5 years
- •Functional class I, II, or II as defined by the American College of Rheumatology (ACR) criteria.
- •Must have failed at least 1 Disease Modifying Anit-Rheumatic Drug (DMARD)
- •Joint count of 10 or more swollen and 12 or more tender.
- •Erythrocyte Sedimentation Rate (ESR) > - 28mm/rr or norning stiffness > - 45 minutes.
排除标准
- •Women and men who are not willing to use an accepted form of contraception.
- •Active vasculitis
- •Treatment with another investigational drug within 30 days
- •History of asthma, angioedema, or anaphylaxix
结局指标
主要结局
Assess the relative safety and preliminary efficacy (clinical activity) of BMS-188667 and BMS-224818 in subjects with rheumatoid arthritis (RA)
次要结局
- Assess the immunogenicity of BMS-188667 and BMS-224818 in subjects with RA, and in a site specific substudy to the protocol, the pharmacokinetics (PK) and pharmacodynamics (PD) of BMS-188667 and BMS-224818 in subjects with RA
研究者
研究点 (61)
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