EUCTR2013-003658-26-NL进行中（未招募）1 期
Treat-to-target strategy for early RA patients in usual clinical practice: The COBRA Cohort Study - COBRA Cohort Study
VU University Medical Center0 个研究点目标入组 120 人开始时间: 2013年10月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
入选标准
- •- RA according to the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) (13)
- •- Age of 18 years and older
- •- Early RA: a diagnosis of RA of less than 2 years
- •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 98
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •- Prior treatment DMARDs (except hydroxychloroquine)
- •- Insulin-dependent Diabetes mellitus
- •- Uncontrollable non-insuline dependent diabetes mellitus
- •- Heart failure NYHA class 3-4
- •- Uncontrollable hypertension
- •- ALAT/ASAT >3 times normal values
- •- Reduced renal function (serum creat >125 µmol/l for male and >100 µmol/l for female)
- •- Contra-indications for methotrexate, sulphasalazine or prednisolone
- •- Indications of probable tuberculosis
- •- Increased risk of harm due to contraindications to the study drugs
- •- Language problems
研究者
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