a phase 2 randomized, double-blind study of amg 108, a fully human monoclonal antibody to il-1r, in patients with rheumatoid arthritis第二阶段的随机、双盲研究amg 108 il-1r完全人类单克隆抗体,在类风湿性关节炎患者.pdfVIP

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2017-09-05 发布于上海
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a phase 2 randomized, double-blind study of amg 108, a fully human monoclonal antibody to il-1r, in patients with rheumatoid arthritis第二阶段的随机、双盲研究amg 108 il-1r完全人类单克隆抗体,在类风湿性关节炎患者.pdf

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a phase 2 randomized, double-blind study of amg 108, a fully human monoclonal antibody to il-1r, in patients with rheumatoid arthritis第二阶段的随机、双盲研究amg 108 il-1r完全人类单克隆抗体,在类风湿性关节炎患者

Cardiel et al. Arthritis Research Therapy 2010, 12:R192 /content/12/5/R192 RESEARCH ARTICLE Open Access A phase 2 randomized, double-blind study of AMG 108, a fully human monoclonal antibody to IL-1R, in patients with rheumatoid arthritis 1* 2 3 4 5 6 Mario H Cardiel , Paul P Tak , William Bensen , Francis X Burch , Sarka Forejtova , Janusz E Badurski , Tarundeep Kakkar7 8 9 10 10 10 , Terry Bevirt , Liyun Ni , Ellen McCroskery , Angelika Jahreis , Debra J Zack Abstract Introduction: Preclinical work has suggested that IL-1 plays a critical role in the pathogenesis of rheumatoid arthritis (RA). The objective of the present study was to determine the effect of a long-acting IL-1 receptor inhibitor, AMG 108, in a double-blind, placebo-controlled, parallel-dosing study in patients with active RA who were receiving stable methotrexate (15 to 25 mg/week). Methods: Patients were randomized equally to receive placebo or 50, 125, or 250 mg AMG 108 subcutaneously every 4 weeks for 6 months. The primary efficacy endpoint was a 20% improvement in the American College of Rheumatology response (ACR20) at week 24; other efficacy endpoints included the ACR50, the ACR70, and the RA disease activity score (28-joint count Disease Activity Score) responses, patient-reported outcomes, and pharmacokinetic parameters. Safety endpoints included treatment-emergent adverse events (AEs), infectious AEs, serious AEs, serious infections, injection site reactions, laboratory abnormalities, and antibodies to AMG 108. Results: Of 813 patients enrolled in the study, 204 patients were randomized to the 50 mg gr