Mease Philip J, Gladman Dafna D, Samad Ahmed S, Coates Laura C, Liu Lyrica X H, Aras Girish A, Collier David H, Chung James B
Rheumatology Clinical Research Division, Swedish Medical Center and Division of Rheumatology, University of Washington, Seattle, Washington, USA.
Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
RMD Open. 2018 Feb 3;4(1):e000606. doi: 10.1136/rmdopen-2017-000606. eCollection 2018.
To evaluate the efficacy of etanercept and methotrexate as monotherapies and as combination therapy in subjects with active psoriatic arthritis (PsA).
The Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects with Psoriatic Arthritis (SEAM-PsA) is an ongoing, global, double-blind, 48-week, randomised, controlled study. Subjects are randomised (1:1:1) to etanercept monotherapy, methotrexate monotherapy or etanercept-methotrexate combination therapy. Endpoints include rates of ACR20 response and Minimal Disease Activity, measures to characterise extra-articular manifestations (dactylitis, enthesitis, nail disease) and safety.
SEAM-PsA will characterise the effects of etanercept with and without background methotrexate and methotrexate alone on PsA manifestations, and provide information of practical importance to clinicians on the optimal treatment of PsA.
评估依那西普和甲氨蝶呤作为单药治疗以及联合治疗对活动性银屑病关节炎（PsA）患者的疗效。
依那西普与甲氨蝶呤联合或单药治疗银屑病关节炎患者的研究（SEAM-PsA）是一项正在进行的全球性、双盲、48周随机对照研究。患者被随机（1:1:1）分为依那西普单药治疗组、甲氨蝶呤单药治疗组或依那西普-甲氨蝶呤联合治疗组。终点指标包括美国风湿病学会20%改善标准（ACR20）反应率和最小疾病活动度，用于描述关节外表现（指（趾）炎、附着点炎、指甲病变）的指标以及安全性。
SEAM-PsA将明确有或无背景甲氨蝶呤时依那西普以及单独使用甲氨蝶呤对PsA表现的影响，并为临床医生提供关于PsA最佳治疗的重要实用信息。
