NCT00605735已完成2 期
A Randomized, Parallel Group, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of BMS-582949 Given Orally to Subjects With Rheumatoid Arthritis Having an Inadequate Response to Methotrexate
Bristol-Myers Squibb9 个研究点 分布在 2 个国家目标入组 121 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 9
- 主要终点
- The primary endpoint is the proportion of subjects achieving an ACR 20 at Week 12
研究概览
简要总结
The purpose of this study is to find out if 300 mg of BMS-582949 given once daily will be more effective than placebo after 12 weeks of treatment in subjects with rheumatoid arthritis who are also taking methotrexate
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a diagnosis of RA for at least 6 months
- •Must be taking methotrexate for at least 3 months & on a stable dose of 7.5-30 mg weekly) for 4 weeks before dosing with study medication
- •Must have at least 6 swollen and at least 8 tender joints
- •CRP above upper limit of normal or ESR > 28 mm/hr
- •Must wash-out (stop taking) other immunosuppressant medications to treat RA (except for methotrexate) before dosing with study medication
排除标准
- •Any infection including TB, HIV, Hepatitis B or C
- •Recent infection requiring antibiotics within 4 weeks
- •History of gastrointestinal disease (such as GERD, gastrointestinal ulcers, heartburn) requiring medical or surgical treatment within 3 months
- •Chronic use of proton pump inhibitors (such as Losec, Prilosec, Prevacid, Nexium), H2 blockers (such as Tagamet, Pepcid, Zantac, Axid) or antacids (such as Mylanta, Maalox)
研究组 & 干预措施
A1
Experimental
干预措施: BMS-582949 (Drug)
P1
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The primary endpoint is the proportion of subjects achieving an ACR 20 at Week 12
时间窗: at Week 12
次要结局
- Proportion of subjects achieving an ACR 20(at each scheduled visit)
- Percent change from baseline to each scheduled visit in DAS28 score(at each scheduled visit)
- Proportion of subjects schieving a 20% change in assessment of pain, disease activity and fatigue(at each scheduled visit)
- Percent change from baseline to each scheduled visit in HAQ score(at each scheduled visit)
- Percent change from baseline to each scheduled visit in ACR scores(at each scheduled visit)
- Proportion of subjects schieving and ACR 50(at each scheduled visit)
- Proportion of subjects schieving and ACR 70(at each scheduled visit)
研究者
研究点 (9)
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