EUCTR2017-003425-15-DK进行中(未招募)1 期
Patients with rheumatoid arthritis and synovitis treated with ultrasound guided intraarticular or intramuscular glucocorticoid injection - A randomised, double-blind, controlled study (Panguian)
Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet0 个研究点目标入组 100 人开始时间: 2017年9月12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
- 100
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
- •Treatment demanding synovitis in up to 4 joints, defined as clinical assessed swollen joint and US grey scale og Doppler score =1, in following joints: interphalangeal(IP)-, proximal interphalangeal (PIP)-, metacarpophalangeal(MCP)-, wrist- (radiocarpal-intercarpal and/or ulnacarpal), ankle- and metatarsophalangeal(MTP).
- •Rheumatoid arthritis according to ACR/EULAR 2010 criteria
- •Above 18 years of age
- •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 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Start of Disease-modifying anti-rheumatic drugs (DMARDs) / biological treatment within the last 12 weeks
- •Change of DMARDs treatment within the last 6 weeks.
- •Change of glucocorticoid treatment within the last 6 weeks.
- •Start of Non-Steroidal Anti-Inflammatory Drugs (NSAID) treatment within the last 10 days.
- •Chronic synovitis in the same IP-, PIP-, MCP-, wrist-, ankle- and MTP 2-5 joints, is defined as either severe destructive erosions, assessed by previously x-rays or persistent synovitis (6 months) despite >1 local joint injection with glucocorticoid according to DANBIO or journal registrations.
- •Treatment demanding synovitis in more than 4 joints, defined as clinical assessed swollen using a 44 joint assessment.
- •Lack of ability to understand the information given about the study.
- •Recent operation in hands or feet (12 month).
- •Allergy to betamethasone.
- •Systemic fungal infection
- •Positive urine HCG among women in the age of fertility.
研究者
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