FONTOLIZUMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

丰托利珠单抗治疗活动性类风湿关节炎患者

• 批准号: 7605242
• 负责人: MARK C GENOVESE
• 金额: $ 1.4万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-15 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605242
• 关键词: American; Body Weight; C-reactive protein; Computer Retrieval of Information on Scientific Projects Database; Dose; Drug Kinetics; Evaluation; Funding; Grant; Individual; Institution; Label; Measures; Patients; Pharmaceutical Preparations; Placebos; Purpose; Randomized; Research; Research Personnel; Resources; Rheumatoid Arthritis; Rheumatology; Safety; Source; Staging; Testing; United States National Institutes of Health; college; day; immunogenicity; response

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 本研究的目的是查明静脉注射 Fontolizumab 是否安全且活动性 RA 患者耐受性良好。该研究分为两个阶段。 A 阶段：开放标签 x 4 剂量，其中改善 20% 的患者继续进行 B 阶段。B 阶段：患者随机接受活性药物或安慰剂 x 5 剂量。 整个研究中测试的剂量水平为 10.0 mg/kg 体重，每 28 天静脉注射一次。将评估 Fontolizumab 在活动性类风湿关节炎受试者中的疗效，根据第 14 周（研究 A 阶段）美国风湿病学会标准 (ACR50) 反应改善 50% 来确定。 1) 评估额外的功效措施，包括： 根据美国风湿病学会标准（ACR20、ACR50、ACR70），在整个研究过程中获得至少 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相对于基线的变化百分比。整个研究过程中 C 反应蛋白值的变化。接受四剂 Fontolizumab 的受试者（A 期）与接受九剂 Fontolizumab 的受试者（A 期和 B 期）的反应持续时间。对接受四剂 Fontolizumab 的应答者与接受九剂 Fontolizumab 的受试者进行长期评估（A 期和 B 期）。 2) 在整个研究过程中评估 Fontolizumab 在活动性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 在活动性类风湿关节炎受试者中的药代动力学 (PK)。 4) 在整个研究过程中评估 Fontolizumab 在活动性类风湿关节炎受试者中的免疫原性。