A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension

ovartis Pharma Services AG0 个研究点目标入组 350 人开始时间: 2011年7月21日最近更新: 2014年6月2日

适应症

试验速览

暂无简介。

•- Diagnosis of rheumatoid arthritis
•- Patients must be either DMARD naive or have failed at least one DMARD agent (e.g. MTX, leflunamide or sulfasalazine)
•- Patients are allowed up to 3 DMARDs at study entry (e.g. MTX, sulfasalazine or hydroxychloroquine) as long as their dose was stable for 4 weeks prior to initiating study treatment
•- Disease activity at screening defined by =6 out of 28 tender joints and =6 out of 28 swollen joints and hsCRP > 10mg/L
•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 375
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 125

•- Patients with severe rheumatoid arthritis (functional status class IV according to the ACR 1991 revised criteria)
•- Previous exposure to secukinumab or any other biologic, including TNF inhibitors
•- Use of high potency opioid analgesics
•- Pregnant or nursing (lactating) women
•- Use of any investigational drug other than rheumatoid arthritis therapy and/or devices at the time of randomization or within 30 days or 5 half-lives of randomization, whichever is longer.
•Other protocol-defined exclusion criteria may apply.

发起方