ISRCTN67054656已完成2 期
A randomised, double-blind, placebo-controlled, phase II study to evaluate the safety and efficacy of CCX354-C in subjects with rheumatoid arthritis partially responsive to methotrexate therapy
ChemoCentryx, Inc. (USA)0 个研究点目标入组 150 人开始时间: 2011年4月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
2011 Abstract results in https://acr.confex.com/acr/2011/webprogram/Paper24548.html conference abstract 2013 Results article in http://dx.doi.org/10.1136/annrheumdis-2011-201605 results 2013 Abstract results in http://dx.doi.org/10.1136/annrheumdis-2012-eular.1886 conference abstract
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adult subjects, with active RA, with at least 8 swollen joints, and 8 tender joints
- •2. Serum C-reactive protein (CRP) above upper limit of normal
- •3. Must have been on stable dose methotrexate for less than or equal to 8 weeks prior to randomisation
- •4. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol
- •5. Female subjects of childbearing potential, and male subjects with partners of childbearing potential, may participate if adequate contraception is used during, and for at least the four weeks after, any administration of study medication
排除标准
- •1. Diagnosed with RA prior to 16 years of age
- •2. Have received sulfasalazine, azathioprine, 6-mercaptopurine, mycophenolate mofetil, tetracycline, cyclosporine, gold, tacrolimus, sirolimus, or other disease modifying anti-rheumatic drug (DMARD) within 8 weeks of randomisation
- •3. Use of infliximab, adalimumab, abatacept, certolizumab, golimumab, or tocilizumab within 8 weeks of randomisation
- •4. Use of leflunomide within 6 months of randomisation
- •5. Use of etanercept or anakinra within 4 weeks of randomisation
- •6. Use of a B-cell depleting agent such as rituximab or ocrelizumab, or cytotoxic agents, such as cyclophosphamide or chlorambucil, within one year of randomisation
研究者
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