NCT00034203已完成2 期
Safety and Efficacy of a Monoclonal Antibody for Treatment of 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
- 试验地点
- 52
研究概览
简要总结
The purpose of this study is to determine whether a humanized monoclonal antibody (efalizumab) is safe and effective in the treatment of rheumatoid arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
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
- •Clinical diagnosis of moderate to severe rheumatoid arthritis.
- •On stable dose of methotrexate.
- •18 to 80 years of age.
- •Less than 275 lbs.
排除标准
- •Joint replacement surgery within 60 days of the start of drug dosing.
- •Intra-articular cortisone injections within 28 days of the start of drug dosing.
- •Pregnancy.
- •History of severe allergic or anaphylactic reactions.
- •Active bacterial, viral, fungal, mycobacterium tuberculosis.
- •Positive PPD test.
- •History of any opportunistic infection.
- •Serious persisting local or systemic infection.
- •History of malignancy within the past five years.
- •Received any vaccine within 28 days of the start of study drug dosing.
- •Joint replacement therapy planned within nine months of the start of study drug dosing.
- •Chronic disorders apart from RA affecting the joints.
- •Significant systemic involvement secondary to RA.
- •COPD, asthma, or other pulmonary disease.
- •Received any DMARD other than methotrexate in the 28 days prior to the start of study drug dosing.
- •Approved biologic RA therapy during the 28 days or 7 half-lives of the drug prior to the start of drug dosing.
- •Investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing.
- •Liver disease or abnormal hepatic function.
- •Serum creatinine level > 1.5 mg/dL.
- •Platelet count < 125,000 cells/mm
- •WBC count < 3,500 cells/mm
- •Seropositive for hepatitis B surface antigen.
- •Seropositive for hepatitis C antibody.
- •Known seropositivity for HIV.
研究组 & 干预措施
未命名试验
干预措施: efalizumab (Drug)
研究者
研究点 (52)
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