FONTOLIZUMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 本研究的目的是了解活动期RA患者静脉注射Fontolizumab是否安全和耐受性良好。这项研究分为两个阶段。阶段A：开放标签×4剂，改善20%的患者继续接受B阶段。阶段B：患者随机接受活性药物或安慰剂×5剂。 整个研究过程中测试的剂量水平为每公斤体重10.0毫克，每28天静脉注射一次。将评估Fontolizumab对活动期类风湿性关节炎患者的疗效，根据美国风湿病学会标准(ACR50)在第14周(研究A阶段)的反应改善50%来确定。 1)评估额外的疗效措施，包括： 在整个研究过程中，根据美国风湿病学会标准(ACR20、ACR50、ACR70)达到至少20%、50%或70%改善的受试者比例。 在整个研究过程中，美国风湿病学会标准的各个组成部分与基线相比的百分比变化。C-反应蛋白在整个研究过程中的变化。接受4剂Fontolizumab的受试者(A期)与接受9剂Fontolizumab的受试者(A期和B期)的反应持续时间进行比较。对接受4剂Fontolizumab的应答者和接受9剂Fontolizumab的受试者(A期和B期)进行的长期评估。 2)在整个研究过程中评估Fontolizumab在活动期类风湿关节炎受试者中的安全性。 3)在整个研究过程中，评估Fontolizumab在活动期类风湿关节炎患者中的药代动力学。 4)在整个研究过程中，评估Fontolizumab在活动期类风湿关节炎患者中的免疫原性。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this study is to find out if Fontolizumab given intravenously is safe and well tolerated by patients with active RA. The study has two stages. Stage A: open label x 4 doses with those patients achieving 20% improvement continue on Stage B. Stage B: patients randomized to receive active drug or placebo x 5 doses. The dose level that is being tested throughout the study is 10.0 mg/kg of body weight, IV every 28 days. Efficacy of fontolizumab in subjects with active rheumatoid arthritis as determined by a 50% improvement of an American College of Rheumatology criteria (ACR50) response at Wk 14 (Stage A of study) will be evaluated. 1)To evaluate additional efficacy measures to include: Proportion of subjects achieving at least 20, 50, or 70% improvement according to the American College of Rheumatology criteria (ACR20, ACR50, ACR70) throughout the study. Percent change from baseline for individual components of the American College of Rheumatology criteria throughout the study. Change in C-reactive protein values throughout the study. Duration of response for subjects who receive four doses of fontolizumab (Stage A) compared with subjects who receive nine doses of fontolizumab (Stage A and B). Long-term evaluation of responders who receive four doses of fontolizumab versus subjects who receive nine doses of fontolizumab (Stage A and B). 2) To evaluate the safety of fontolizumab in subjects with active rheumatoid arthritis throughout the study. 3) To evaluate the pharmacokinetics (PK) of fontolizumab in subjects with active rheumatoid arthritis throughout the study. 4) To evaluate the immunogenicity of fontolizumab in subjects with active rheumatoid arthritis throughout the study.