ACTRN12617000877381进行中(未招募)3 期
METHODS - A randomised controlled trial of METhotrexate to treat Hand Osteoarthritiswith Synovitis
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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