NCT00162201已完成1 期
An Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF Therapy
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2003年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Comparison of each subject's synovial tissue markers
研究概览
简要总结
Study to assess changes in synovial tissue before and after treatment with Abatacept in subjects with RA who remained on their background disease modifying anti-arthritis medications but who have failed previous therapy with anti-TNF (tumor necrosing factor)blocking agents.
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
- •RA for at least 1 year
- •Clear clinical signs of active RA in 1 knee joint
- •Meet ARA (1987) criteria for diagnosis of RA and ACR (1991) criteria for RA functional classes I, II, or III
- •Inadequate clinical response to a minimum of 3 months of therapy with anti-TNF-blocking agents
- •Taking background DMARDs for a minimum of 3 months and at stable doses for at least 28 days
排除标准
- •Serious bacterial infection in last 3 months
- •History of TB
- •History of cancer within 5 years
- •Evidence of latent or active bacterial or viral infection
- •Intra-articular corticosteroids within 3 months
- •Exposure to live vaccines
- •Exposure to CTLA4Ig or BMS-188667
- •Treatment with immunoadsorption column(s), mycophenolate mofetil, leflunomide, anakinra, cyclosporine, etanercept, adalimumab, infliximab, azathioprine, oral or parenteral gold, D-penacillamine, calcineurin inhibitors, cyclophosphamide or other alkylating agents
研究组 & 干预措施
1
Experimental
干预措施: Abatacept (Drug)
结局指标
主要结局
Comparison of each subject's synovial tissue markers
时间窗: at baseline and after 4 months of treatment with abatacept
次要结局
- assess baseline & post treatment synovitis by dynamic gadolinium enhanced MRI; determine concentrations of abatacept in synovial fluid & serum(after 4 months of treatment)
- assess safety & tolerability of abatacept(administered for 4 months)
研究者
研究点 (1)
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