A Pilot Study of Musculoskeletal Ultrasound Assessment in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Evidence of reliability of intra- and inter-rater ultrasound agreement for power Doppler synovitis score
研究概览
简要总结
Little is currently known as to the predictive value of ultrasound in guiding the decision to taper drug treatment in patients with stable rheumatoid arthritis, nor the influence that patients' views and opinions regarding their medications may have upon this. In this study, patients with stable rheumatoid arthritis will undergo a simple examination of their joints to look for any swelling or tenderness followed by an ultrasound scan to look for joint inflammation. Half of the patients will also complete an interview to assess their views and opinions of arthritis drug treatment. The study will be completed in a single patient visit - no invasive tests will be performed, and no changes to treatment will be made.
This study is being conducted as part of a Masters degree from Newcastle University. The results of this study will be used to inform the feasibility of inclusion of ultrasound assessment within the design of a future PhD study to investigate potential markers of remission in patients with rheumatoid arthritis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of rheumatoid arthritis with symptom onset at least 12 months previously
- •Current disease-modifying anti-rheumatic drug (DMARD) therapy or biologic therapy
- •Currently stable arthritis defined as no change in DMARD treatment over previous 6 months, and no use of steroids (enteral, parenteral or intra-articular) over previous 6 months
排除标准
- •Inability to provide informed consent
- •Current or recent (within 4 months) participation within another clinical trial
结局指标
主要结局
Evidence of reliability of intra- and inter-rater ultrasound agreement for power Doppler synovitis score
时间窗: At recruitment
Defined as Kappa statistic of at least 0.4.
次要结局
- Simplified Disease Activity Index (SDAI)(At recruitment)
- Disease Activity Score (DAS)(At recruitment)
- Qualitative data relating to patients' views and opinions of their arthritis medication(At recruitment)
- Disease Activity Score in 28 joints (DAS-28)(At recruitment)