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临床试验/ACTRN12617000877381
ACTRN12617000877381进行中(未招募)3 期

METHODS - A randomised controlled trial of METhotrexate to treat Hand Osteoarthritiswith Synovitis

Monash University0 个研究点目标入组 97 人开始时间: 2017年6月15日最近更新:

试验速览

阶段
3 期
状态
进行中(未招募)
入组人数
97

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
40 Years 至 75 Years(—)
性别
All

入选标准

  • 1. Aged 40 - 75 years with symptomatic radiological hand osteoarthritis and synovitis
  • 2. A pain score of greater than or equal to 40mm on a 100mm visual analogue scale and radiological osteoarthritis (Kellgren and Lawrence grade greater than or equal to 2) in at least one joint
  • 3. Evidence of synovitis determined from magnetic resonance imaging with a grade greater than or equal to 1 in at least one joint

排除标准

  • 1. Concomitant rheumatic disease, inflammatory joint disease, psoriatic arthritis, ankylosing spondylitis, or gout
  • 2. Contraindication to methotrexate (e.g. renal, liver or haematological condition, cancer including skin cancer, serious infections requiring hospitalisation in the last 5 years, known or past infection with HIV, Hepatitis B or C, Tuberculosis, or known lung disease with scarring (any fibrosis or evidence of past tuberculosis exposure on chest x-ray), concurrent regular prednisolone use, taking regular Trimethoprim or Bactrim antibiotics, egg or flu vaccination allergy, women who are pregnant, breast-feeding or trying to become pregnant, or men who father a child)
  • 3. Contraindication to magnetic resonance imaging (e.g. implanted pacemaker, metal sutures, presence of shrapnel or iron filings in the eye, or claustrophobia)
  • 4. Unable to complete informed consent.

研究者

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