CLINICAL TRIAL: RITUXIMAB IN REFRACTORY ADULT AND JUVENILE MYOSITIS

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。 皮肌炎和多发性肌炎是两种疾病，其中有肌肉炎症，导致虚弱和残疾。 这两种疾病的病因尚不清楚，治疗效果有限。 在这项研究中，利妥昔单抗将被研究，以确定其在治疗这两种疾病的患者，已难治性标准治疗的疗效。 利妥昔单抗是一种抗体，已被开发用于从体内清除某种类型的炎症细胞，目前已成功用于治疗多种疾病。 这种药物在这两种肌肉疾病中的疗效和安全性尚不清楚。 研究受试者将依次接受药物和安慰剂给药，患者和研究者均不知道治疗顺序。 药物和安慰剂将分别作为两次单独输注给药。 参与者将在治疗前后进行一系列评估，为期几个月（共14次访问），包括测量力量，填写问卷和采血。 还将采集血液和尿液用于未来分析。 在美国和国外的29家研究中心共招募了202例受试者参与本研究。

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.