NCT00049751已完成3 期
A Multicenter Study of the Safety of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 3,000
- 试验地点
- 61
- 主要终点
- Change in disease activity score at visit week 12 as compared to baseline
研究概览
简要总结
The purpose of the study is to evaluate safety by collecting serious adverse events in subjects with moderately to severely active rheumatoid arthritis who are unable to obtain etanercept and who have failed one or more prior disease-modifying antirheumatic drugs (DMARDs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects must meet ACR criteria for diagnosis of RA for at least 3 months, must meet ACR Functional Class I, II or III (1992 criteria) and must have a confirmed diagnosis of active moderate to severe rheumatoid arthritis as defined by 6 or more swollen joints and 9 or more tender joints;
- •must also have DAS of 3.2 or greater at study entry,
- •normal laboratory parameters and ESR >20,
- •satisfactory response or intolerance to one or more prior DMARDs and
- •be willing and able to give informed consent.
排除标准
- •Previous treatment with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies resulting in persistent CD4 lymphopenia,
- •history of acute inflammatory joint disease other than RA,
- •prior treatment with cyclophosphamide or chlorambucil,
- •prior treatment with intravenous immunoglobulin within 70 days,
- •history of malignant lymphoma,
- •history of uncontrolled diabetes,
- •unstable ischemic heart disease,
- •active inflammatory bowel disease,
- •active peptic ulcer disease or stroke,
- •positive HIV status,
- •positive serology for Hepatitis B or C,
- •no previous history of tuberculosis or listeria infection,
- •no previous history of cancer other than successfully treated skin cancer;
- •women can not be pregnant or be breastfeeding
结局指标
主要结局
Change in disease activity score at visit week 12 as compared to baseline
次要结局
未报告次要终点
研究者
研究点 (61)
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