FONTOLIZUMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究的目的是确定Fontolizumab静脉给药是否安全，活动性RA患者是否耐受良好。研究分两个阶段。A期：开放标签× 4次给药，达到20%改善的患者继续进入B期。阶段B：患者随机接受活性药物或安慰剂x5次给药。 整个研究期间检测的剂量水平为10.0 mg/kg体重，IV，每28天一次。将评价fontolizumab在活动性类风湿性关节炎受试者中的疗效，根据第14周（研究阶段A）时美国风湿病学会标准（ACR 50）缓解改善50%确定。 1）评价其他有效性指标，包括： 整个研究期间根据美国流变学会标准（ACR 20、ACR 50、ACR 70）获得至少20%、50%或70%改善的受试者比例。 在整个研究期间，美国流变学会标准的单个组分较基线的百分比变化。整个研究期间C反应蛋白值的变化。与接受9剂fontolizumab（A和B阶段）的受试者相比，接受4剂fontolizumab（A阶段）的受试者的缓解持续时间。接受4剂fontolizumab的应答者与接受9剂fontolizumab的受试者的长期评价（阶段A和B）。 2)评价fontolizumab在整个研究期间在活动性类风湿关节炎受试者中的安全性。 3)评价整个研究期间fontolizumab在活动性类风湿关节炎受试者中的药代动力学（PK）。 4)在整个研究期间，评价fontolizumab在活动性类风湿关节炎受试者中的免疫原性。

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.