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:
相关药物
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.
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