CLINICAL TRIAL: RITUXIMAB IN REFRACTORY ADULT AND JUVENILE MYOSITIS

临床试验：利妥昔单抗治疗难治性成人和青少年肌炎

• 批准号: 7718918
• 负责人: Pushpa Narayanaswami
• 金额: $ 0.2万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718918
• 关键词: Adolescent; Adult; Aftercare; Antibodies; Blood; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Condition; Dermatomyositis; Disease; Evaluation; Funding; Future; Grant; Inflammation; Inflammatory; Infusion procedures; Institution; Measurement; Muscle; Myopathy; Myositis; Participant; Patients; Pharmaceutical Preparations; Placebos; Questionnaires; Recruitment Activity; Refractory; Research; Research Personnel; Resources; Safety; Series; Site; Source; Standards of Weights and Measures; United States; United States National Institutes of Health; Urine; Visit; disability; neuronal cell body; rituximab

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. Dermatomyositis and polymositis are two diseases in which there is inflammation in muscles that leads to weakness and disability. The cause of both of these diseases is unknown and treatments are limited in their efficacy. In this study Rituximab will be studied to determine its efficacy in the treatment of patients with these two diseases that have been refractory to standard treatments. Rituximab, an antibody, has been developed to remove a certain type of inflammatory cell from the body and is currently being used to treat several conditions successfully. The efficacy and safety of this drug in these two muscle diseases is unknown. Study participants will be given both the drug and placebo sequentially with neither the patient nor the investigator knowing the order of treatment. The drug and placebo will each be given as two separate infusions. Participants will undergo a series of evaluations both before and after the treatments, for several months (for a total of 14 visits), including measurement of strength, completing questionnaires and having blood obtained. Blood and urine will also be collected for future analysis. A total of 202 subjects are being recruited to participate in this study across 29 sites both within the United States and abroad.

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。 皮肌炎和多发性肌炎是肌肉发炎导致虚弱和残疾的两种疾病。这两种疾病的病因尚不清楚，治疗效果有限。在这项研究中，将对利妥昔单抗进行研究，以确定其对标准治疗无效的这两种疾病患者的疗效。利妥昔单抗是一种抗体，已经被开发出来用于从体内清除某种类型的炎症细胞，目前正被成功地用于治疗几种疾病。这种药物对这两种肌肉疾病的疗效和安全性尚不清楚。研究参与者将按顺序同时给予药物和安慰剂，患者和研究人员都不知道治疗顺序。药物和安慰剂将分别作为两种不同的输液给予。参与者将在治疗前和治疗后接受一系列评估，为期几个月(总共14次访问)，包括测量力量、填写问卷和抽血。血液和尿液也将被采集以供将来分析。共有202名受试者被招募参加这项研究，涉及美国和国外的29个地点。