CLINICAL TRIAL: RITUXIMAB WITH OR WITHOUT METHOTREX IN PSORIATIC ARTHRITIS AND P

这个子项目是许多利用 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。 银屑病关节炎（PsA）是一种病因不明的慢性炎症性关节炎。 目前，甲氨蝶呤（MTX），环孢素和柳氮磺胺吡啶已被证明在治疗银屑病A的适度疗效，虽然柳氮磺胺吡啶相关的银屑病皮肤病变没有显着的效果。 抗TNF药物对关节炎和银屑病都有好处，但是很大一部分患者没有获得足够的益处，有些根本没有反应。因此，在相当多的患者中仍然存在对PsA的充分治疗的未满足的需求。 利妥昔单抗是一种嵌合的鼠/人单克隆抗体，针对正常和恶性前B和成熟B细胞表面上发现的CD 20抗原。 它被批准用于治疗复发性或难治性低级别或滤泡性、CD 20+、B细胞非霍奇金淋巴瘤。利妥昔单抗治疗，特别是与甲氨蝶呤或环磷酰胺联合治疗，也已被证明在治疗类风湿性关节炎（RA）中有效，类风湿性关节炎是一种与PsA炎性滑膜炎具有相当多重叠特征的疾病。 已知PsA的滑膜浸润和银屑病的皮肤病变含有大量B细胞，即利妥昔单抗治疗的靶细胞。 本研究将评估利妥昔单抗作为PsA潜在替代治疗的安全性和有效性，这些患者的其他治疗已被证明是不够的。

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. Psoriatic arthritis (PsA) is a chronic inflammatory arthritis of unknown etiology. Currently, methotrexate (MTX), cyclosporine and sulfasalazine have demonstrated modest efficacy in the treatment of PsA, although sulfasalazine had no significant effect on associated psoriatic skin lesions. Anti-TNF medications have benefited both the arthritis and psoriasis components of the disease, however a significant portion of patients do not achieve adequate benefit and some do not respond at all. Thus, there remains an unmet need for adequate treatment of PsA in a substantial number of patients. Rituximab is a chimeric, murine/human monoclonal antibody directed against the CD20 antigen found on the surface of normal and malignant pre-B and mature B cells. It is approved for the treatment of relapsed or refractory low grade or follicular, CD20+, B-cell non-Hodgkin's lymphoma. Therapy with rituximab, especially in combination with methotrexate or cyclophosphamide, has also been shown to be efficacious in the treatment of rheumatoid arthritis (RA), a condition with considerable overlapping features with the inflammatory synovitis of PsA. It is known that the synovial infiltrate of PsA and skin lesions of psoriasis contain numerous B cells, the target cell of rituximab therapy. This study will assess the safety and efficacy of rituximab as a potential alternative treatment for PsA in those patients where other therapies have proven inadequate.