EUCTR2011-000102-21-HU进行中（未招募）不适用
A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - NURTURE-1
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 548
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
- •- Male or non-pregnant, non-lactating female patients
- •- Presence of rheumatoid arthritis classified by ACR 2010 revised criteria for at least 3 months before screening
- •- At Baseline : disease activity criteria defined by = 6 tender joints out of 68 and = 6 swollen joints out of 66 WITH at least 1 of the following at screening:
- •Anti-CCP antibodies positive OR
- •Rheumatoid Factor positive
- •AND WITH at least 1 of the following at screening:
- •hsCRP = 10mg/L
- •ESR = 28 mm/1st hr
- •- Patients must have been taking at least one anti-TNFa agents given at an approved dose for at least 3 months before randomization and have experienced an inadequate response to treatment or have been intolerant to at least one administration of an anti-TNFa agent
- •- Patients must be taking Methotrexate or any other DMARD (but not more than 1 DMARD) for at least 3 months before randomization and have to be on a stable dose at least 4 weeks before randomization (7,5 to 25mg/week for Methotrexate or other DMARD at maximum tolerated dose)
- •Other protocol-defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 439
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 109
排除标准
- •- Chest x-ray with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
- •- Rheumatoid arthritis patients functional status class IV according to the ACR 1991 revised criteria
- •- Patients who have ever received biologic immunomodulating agents except for those targeting TNFa
- •- Previous treatment with any cell-depleting therapies
- •Other protocol-defined exclusion criteria may apply.
研究者
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