Pharmacological Treatment In Osteoarthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Pain intensity measured by 100 mm Visual Analog Scale (VAS)
研究概览
简要总结
The purpose of this study is to determine the efficacy of hydroxychloroquine in hand osteoarthritis.
详细描述
Osteoarthritis is the most common joint disease, most frequently involving the hands, resulting in pain, stiffness and loss of hand function. At present, there is no option to prevent the onset or the progression of hand osteoarthritis (OA). It is believed that inflammation plays an important role in the pathogenesis of OA and that anti-inflammatory drugs might be an effective treatment for OA. Anti-malarial agents like chloroquine and hydroxychloroquine are potential anti-inflammatory drugs and hydroxychloroquine has already proven to be an effective suppressor of inflammation in rheumatoid arthritis. Several previous studies with hydroxychloroquine in hand OA also showed a possible effect on pain and inflammation, but these studies were mostly retrospective with a small number of patients. This is the first prospective, randomised, placebo-controlled study to determine the effect of hydroxychloroquine in hand osteoarthritis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years
- •Primary hand OA according to the ACR classification
- •Heberden or Bouchard nodule or Kellgren-Lawrence grade 1, 2 or 3 changes in ≥ 2 symptomatic joints
- •Pain in the dominant hand ≥ 12 months
- •Use of an NSAID for ≥ 1 episode of pain
- •Written informed consent
排除标准
- •Secondary hand OA, e.g. haemochromatoses, rheumatoid arthritis, posttraumatic
- •Kellgren-Lawrence grade 4 OA
- •Use of hydroxychloroquine within 3 months before entering the study
- •Use of NSAIDs or corticosteroids within 7 days before entering the study
- •Retinopathy
- •Myasthenia gravis
- •Known allergy or hypersensitivity for hydroxychloroquine
研究组 & 干预措施
Placebo
干预措施: cellulose (Drug)
Hydroxychloroquine
干预措施: Hydroxychloroquine (Drug)
结局指标
主要结局
Pain intensity measured by 100 mm Visual Analog Scale (VAS)
时间窗: 24 weeks
次要结局
- Pain intensity measured by 100 mm VAS(6, 12 weeks)
- Radiological progression measured by the anatomical lesion progression system from Verbruggen et al.(24 weeks)
- Hand function measured by Arthritis Impact Measurement Scales 2 short form (AIMS2-SF) and Australian/Canadian Osteoarthritis Hand Index (AUSCAN)(6, 12 and 24 weeks)
研究者
WeiChing Lee
pharmacist
Maasstad Hospital