跳至主要内容
临床试验/EUCTR2012-002573-62-SE
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

发起方
The Karolinska Institute, ClinTRID

相似试验