EUCTR2012-002573-62-SE进行中(未招募)1 期
Doppler quantitative evaluation and follow-up over 12 months in RA patients with moderate and high disease activity who are candidates for biologic add-on therapy with Adalimumab
The Karolinska Institute, ClinTRID0 个研究点目标入组 120 人开始时间: 2012年8月14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
- 性别
- All
入选标准
- •Adult patient (> 18 years of age), male or female
- •Rheumatoid arthritis according to the 1987 ACR or 2010 EULAR/ACR classification criteria
- •Moderate to high disease activity
- •Ongoing anti-rheumatic treatment with DMARD, with stable dosage during the last 3 months, and being a candidate for anti-TNF add-on therapy OR ongoing treatment with first anti-TNF therapy and being a candidate for switch to another anti-TNF therapy
- •Women with child-bearing potential: use of an adequate method of contraception to avoid pregnancy throughout the study
- •Signed Informed Consent*
- •* Signed Informed Consent must be obtained before any study specific procedures take place.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Biologic treatment with Adalimumab before inclusion
- •Two or more ongoing biologic treatments before inclusion
- •Treatment with other biologic treatment than anti-TNF therapy before inclusion
- •Any contraindication for treatment with Adalimumab
- •Intraarticular corticosteroid injection during the last 4 weeks before each follow-up visit
- •Positive for tuberculosis or hepatitis B.
- •Ongoing pregnancy or lactation
研究者
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