Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo - Assessment of Structural and Clinical Action of Magnetic Resonance Imaging
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- pain assessed with EVA
研究概览
简要总结
Interest of methotrexate in inflammatory rheumatisms was demonstrated since several years.
At present time,there is no effective treatment against digital arthritis. The investigators purpose to measure the efficacy of methotrexate on digital arthritis.
In this aim, two groups were compared. The first group receive 10mg/week of methotrexate administered in one shot (every Monday for example)during 12 months. The second group receive 10mg/week of placebo according to the same procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hand arthritis
- •pain over 40/100
- •stable treatment since 4 weeks at least with non-steroid analgesic
- •between 45 et 85 years
排除标准
- •pregnancy or breast feeding women
- •hyaluronic acid injection within the past 6 months
- •cortisonic derivated injection within the past 3 months
研究组 & 干预措施
Methotrexate
Patients with digital arthritis receiving methotrexate treatment at 10mg/week during 12 months
干预措施: Methotrexate (Drug)
Placebo
Patients with digital arthritis receiving placebo at 10mg/week during 12 months
干预措施: Placebo (Drug)
结局指标
主要结局
pain assessed with EVA
时间窗: at screening visit, inclusion visit, first month, and every month during one year
次要结局
- Quality of life survey : SF-36(at inclusion visit, first month, and every month during one year)