A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents

ovartis Pharma AG0 个研究点目标入组 234 人开始时间: 2012年10月23日最近更新: 2016年4月11日

适应症

试验速览

暂无简介。

•1) Presence of Rheumatoid Arthritis classified by ACR 2010 revised criteria for at least 3 months
•2) Disease activity defined by =6 tender joints out of 68 and = 6 swollen joints out of 66 at baseline and with: either Anti-CCP antibodies positive OR Rheumatoid Factor positive
•and with either hsCRP = 10 mg/L OR ESR =28 mm/1st hr
•3) Intake of at least one anti-TNF-a agent such as etanercept, adalimumab, infliximab, certolizumab or golimumab for at least 3 months before entering the study and to have experienced an inadequate response to treatment or to have been intolerant to at least one administration
•Other protocol-defined inclusion criteria may apply
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 187
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 47

•1) Current RA functional status class IV according to the ACR 1991 revised criteria
•2) Previous use of secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor and/or any history of hypersensitivity to secukinumab or its excipient or to drugs of similar chemical classes
•3) Subjects who have ever received biologic immunomodulating agents except for those targeting TNFa
•Other protocol-defined exclusion criteria may apply

发起方