EUCTR2013-002778-38-IT进行中（未招募）1 期
A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy and safety of gevokizumab in the treatment of patients with giant cell arteritis
Institut de Recherches Internationales Servier (IRIS)0 个研究点目标入组 50 人开始时间: 2013年10月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •- Relapsing GCA with systemic symptoms,
- •- Diagnosis of GCA according to ACR criteria and at least one previous GCA relapse,
- •- Oral CS therapy,
- •- Male or female, age = 50 years,
- •- Weight > 40 kg at selection,
- •- For subjects with reproductive potential, a willingness to use highly effective contraceptive measures.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- relapse of GCA with symptoms indicative of a risk of ischemic event,
- •- History of recent, permanent or transient visual loss due to GCA and the presence of any specific visual abnormality,
- •- History of major ischemic event, unrelated to GCA,
- •- History of fibromyalgia,
- •- Evidence of active pulmonary infection, active TB disease, or malignancy, or suspicion of active or latent TB, or exposition to TB,
- •- History of severe allergic or anaphylactic reactions to monoclonal antibodies,
- •- History of malignancy within 5 years prior to selection,
- •- Known immunodeficiency,
- •- Infectious disease,
- •- Pregnancy, breastfeeding or possibility to become pregnant during the study
研究者
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