EUCTR2011-006058-94-DE进行中（未招募）不适用
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 - REASSURE 2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 234
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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