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临床试验/EUCTR2013-004006-26-DK
EUCTR2013-004006-26-DK进行中(未招募)1 期

Optical images for monitoring treatment changes in rheumatoid arthritis – a longitudinal study with Rheumascan

Knowledge Centre for Rheumatology and Back Diseases0 个研究点开始时间: 2013年12月18日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方

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

  • Inclusion criteria
  • A. – RA-patients.
  • RA according to ACR/EULAR 2010 criteria (study A & B).
  • Above 18 years of age (study A & B).
  • At least one clinical inflamed joint in hands (study A & B).
  • Clinical indication for escalating treatment (study B).
  • B. – Healthy controls.
  • No inflammatory joint disease
  • No chronic pain syndrome.
  • No current joint symptoms
  • 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 100
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • Exclusion criteria
  • Lack of ability to understand the information given about the study.
  • Recent operation i the hands (within the last 4 weeks).
  • Impaired renal function at inclusion (GFR < 90).
  • Significant decreased liver function (liver enzymes > 2 x upper normal limit at time of inclusion).
  • Previous allergy to contrast agents.
  • Contraindications to ICG (Iod allergy, untreated hyperthyroidism, allergy to ICG-pulsion)
  • Contraindications to MRI (pacemaker, claustrofobia, none compatible MRI metal in the body, allergy to Dotarem).
  • Positive urine HCG among women in the age of fertility.

研究者

发起方
Knowledge Centre for Rheumatology and Back Diseases

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