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临床试验/EUCTR2017-003425-15-DK
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

发起方
Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet

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